Chronic Plaque Psoriasis
Conditions
Keywords
Psoriasis, Chronic Plaque Psoriasis, Bimekizumab
Brief summary
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with moderate to severe chronic plaque psoriasis in order to guide the selection of doses and clinical indices in the Phase 3 development program.
Interventions
DRUGBimekizumab
Subjects will be randomized to receive a combination of injections of Bimekizumab.
OTHERPlacebo
Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Sponsors
Parexel
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has provided informed consent * Chronic plaque psoriasis for at least 6 months prior to Screening * PASI (Psoriasis Area and Severity Index) \>=12 and BSA (body surface area) \>=10% and IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale * Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy * Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug * Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication
Exclusion criteria
* Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis * Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastrointestinal or neurological disease * Subject has any significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol * Subject taking prohibited psoriatic medications * Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug administration * Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17) therapy or has been exposed to more than 1 biological response modifier (limited to anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis prior to the Baseline * Subject has any current sign or symptom that may indicate an active infection (except for common cold)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Week 12 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Erythrocytes mean corpuscular volume was measured in femtolitres (fL). |
| Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 | Week 8 | The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. |
| Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 | Week 8 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Week 12 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease. |
| Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | Week 12 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12. |
| Plasma Concentrations of Bimekizumab During the Study | Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point. |
| Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab | From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28) | The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent. |
| Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab | From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28) | The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent. |
| Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50) | From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28) | The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent. |
| Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment | Baseline (Week 0) | Antibody positive status prior study treatment was defined as having an antibody level greater than (\>) 28.5% at Baseline (Week 0). |
| Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment | From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28) | Overall antibody positive was defined as having a value of \> 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples. |
| Percentage of Participants With at Least One Adverse Event (AE) During the Study | From Screening to End of Safety Follow-up (up to Week 32) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. |
| Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | From Screening to End of Safety Follow-up (up to Week 32) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. |
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Platelets was measured in number of platelets per liter (10\^9/L). |
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L). |
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg). |
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Erythrocytes was measured in number of red blood cells per liter (10\^12/L). |
| Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 | Week 12 | The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. |
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10\^9/L). |
| Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L). |
| Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L). |
| Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Creatinine and bilirubin were measured in micromols per liter (μmol/L). |
| Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | C Reactive Protein was measured in milligrams per liters (mg/L). |
| Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Urine pH was measured on a pH scale. |
| Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | From Baseline (Week 0) until Week 12 | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. |
| Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | From Baseline (Week 0) until Week 12 | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. |
| Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | From Baseline (Week 0) until Week 12 | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. |
| Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | From Baseline (Week 0) until Week 12 | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. |
| Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | From Baseline (Week 0) until Week 12 | Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12. |
| Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Blood pressure was measured in millimeters of mercury (mmHg). |
| Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Pulse rate was measured in beats per minute (beats/min). |
| Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Temperature was measured in degrees Celsius (°C). |
| Percentage of Participants With Clinically Significant Physical Examination Abnormalities | At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose) | The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Any clinically significant abnormal findings during the study were captured as adverse events. |
| Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Percentages were based on the number of participants with a non-missing measurement for that variable at the visit. |
| Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose) | Hematocrit was measured in volume percentage (%) of red blood cells in blood. |
Countries
Canada, Czechia, Hungary, Japan, Poland, United States
Participant flow
Recruitment details
The study started to enroll participants in August 2016 and concluded in July 2017.
Pre-assignment details
The study included a 2-4 week Screening Period and a 12-week Treatment Period. Completed study was defined as completed the 12-week double-blind Treatment Period. After Treatment Period participants either enrolled in an extension study (PS0011) or entered a 20-week Safety Follow-Up Period. Participant Flow refers to the Randomized Set.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). | 42 |
| Bimekizumab 64 mg Q4W Participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. | 39 |
| Bimekizumab 160 mg Q4W Participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. | 43 |
| Bimekizumab 160 mg w/ LD Q4W Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. | 40 |
| Bimekizumab 320 mg Q4W Participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. | 43 |
| Bimekizumab 480 mg Q4W Participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. | 43 |
| Total Title | 250 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 | 1 | 0 | 1 |
| Overall Study | Lab withdrawal criterion met | 0 | 1 | 2 | 2 | 2 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Patient moved abroad | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Patient randomized by mistake | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Positive for Tuberculosis | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Screening exclusion criteria met | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Subject positive for Hep B | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Bimekizumab 64 mg Q4W | Bimekizumab 160 mg Q4W | Bimekizumab 160 mg w/ LD Q4W | Bimekizumab 320 mg Q4W | Bimekizumab 480 mg Q4W | Total Title | Placebo |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants | 4 Participants | 5 Participants | 22 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 40 Participants | 35 Participants | 39 Participants | 36 Participants | 225 Participants | 39 Participants |
| Age, Continuous | 44.2 years STANDARD_DEVIATION 13.8 | 43.4 years STANDARD_DEVIATION 12.4 | 46.5 years STANDARD_DEVIATION 15.2 | 42.6 years STANDARD_DEVIATION 13.6 | 42.9 years STANDARD_DEVIATION 15.2 | 44.3 years STANDARD_DEVIATION 13.7 | 46.7 years STANDARD_DEVIATION 12.3 |
| Race/Ethnicity, Customized American Indian/Alaskan native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 6 Participants | 3 Participants | 4 Participants | 22 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 35 Participants | 39 Participants | 33 Participants | 39 Participants | 38 Participants | 223 Participants | 39 Participants |
| Sex: Female, Male Female | 19 Participants | 11 Participants | 11 Participants | 15 Participants | 14 Participants | 87 Participants | 17 Participants |
| Sex: Female, Male Male | 20 Participants | 32 Participants | 29 Participants | 28 Participants | 29 Participants | 163 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 39 | 0 / 43 | 0 / 40 | 0 / 43 | 0 / 43 | 0 / 42 | 0 / 39 | 0 / 43 | 0 / 40 | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 8 / 42 | 16 / 39 | 12 / 43 | 12 / 40 | 14 / 43 | 10 / 43 | 0 / 42 | 0 / 39 | 0 / 43 | 0 / 40 | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 1 / 42 | 0 / 39 | 0 / 43 | 0 / 40 | 0 / 43 | 1 / 43 | 0 / 42 | 1 / 39 | 0 / 43 | 0 / 40 | 0 / 43 | 0 / 43 |
Outcome results
Primary
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 12
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 46.2 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 67.4 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 75.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 79.1 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 72.1 percentage of participants |
p-value: <0.0001Regression, Logistic
p-value: <0.0001Regression, Logistic
p-value: <0.0001Regression, Logistic
p-value: <0.0001Regression, Logistic
Secondary
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose)
Calcium, chloride, potassium, magnesium, sodium, urea nitrogen, cholesterol and glucose were measured in millimoles per liter (mmol/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 1 | 0.5 mmol/L | Standard Deviation 1.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 12 | -0.014 mmol/L | Standard Deviation 0.093 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride SFU | 1.0 mmol/L | Standard Deviation 1.6 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 2 | 0.00 mmol/L | Standard Deviation 1.16 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 2 | 0.29 mmol/L | Standard Deviation 1.62 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 1 | 0.50 mmol/L | Standard Deviation 1.59 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 8 | -0.28 mmol/L | Standard Deviation 1.29 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 1 | -0.010 mmol/L | Standard Deviation 0.074 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 8 | 0.01 mmol/L | Standard Deviation 0.39 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 4 | -0.06 mmol/L | Standard Deviation 0.59 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 12 | 0.3 mmol/L | Standard Deviation 1.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 4 | -0.023 mmol/L | Standard Deviation 0.077 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 12 | -0.17 mmol/L | Standard Deviation 1.35 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium SFU | 0.10 mmol/L | Standard Deviation 0.36 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 8 | 0.2 mmol/L | Standard Deviation 2.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 6 | -0.033 mmol/L | Standard Deviation 0.07 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium SFU | 0.053 mmol/L | Standard Deviation 0.093 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 4 | -0.14 mmol/L | Standard Deviation 1.16 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose SFU | -0.40 mmol/L | Standard Deviation 0.48 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol SFU | -0.28 mmol/L | Standard Deviation 0.3 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 8 | -0.08 mmol/L | Standard Deviation 0.67 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 2 | 0.0 mmol/L | Standard Deviation 2.3 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 8 | -0.026 mmol/L | Standard Deviation 0.07 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 6 | -0.1 mmol/L | Standard Deviation 2.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 6 | -0.12 mmol/L | Standard Deviation 0.96 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 6 | 0.05 mmol/L | Standard Deviation 0.46 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 12 | -0.20 mmol/L | Standard Deviation 0.88 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 4 | 0.1 mmol/L | Standard Deviation 1.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 1 | -0.04 mmol/L | Standard Deviation 0.47 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 1 | -0.010 mmol/L | Standard Deviation 0.076 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 6 | -0.5 mmol/L | Standard Deviation 2 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen SFU | 0.65 mmol/L | Standard Deviation 1.74 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 2 | -0.012 mmol/L | Standard Deviation 0.063 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 12 | 0.22 mmol/L | Standard Deviation 1.27 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 12 | -0.05 mmol/L | Standard Deviation 0.35 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 8 | -0.6 mmol/L | Standard Deviation 2 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 6 | -0.04 mmol/L | Standard Deviation 0.32 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 6 | -0.013 mmol/L | Standard Deviation 0.054 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 8 | -0.023 mmol/L | Standard Deviation 0.084 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 4 | -0.2 mmol/L | Standard Deviation 1.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 12 | -0.4 mmol/L | Standard Deviation 2 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 2 | 0.03 mmol/L | Standard Deviation 0.3 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 6 | 0.44 mmol/L | Standard Deviation 1.42 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 4 | 0.09 mmol/L | Standard Deviation 0.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 12 | -0.011 mmol/L | Standard Deviation 0.095 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 2 | -0.3 mmol/L | Standard Deviation 1.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium SFU | -0.5 mmol/L | Standard Deviation 2.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 2 | -0.003 mmol/L | Standard Deviation 0.082 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 2 | -0.13 mmol/L | Standard Deviation 0.71 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 4 | 0.37 mmol/L | Standard Deviation 1.42 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium SFU | -0.095 mmol/L | Standard Deviation 0.083 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 1 | -0.1 mmol/L | Standard Deviation 1.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 1 | 0.08 mmol/L | Standard Deviation 0.45 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 4 | -0.029 mmol/L | Standard Deviation 0.073 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 1 | -0.16 mmol/L | Standard Deviation 1.09 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 8 | 0.37 mmol/L | Standard Deviation 1.48 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 1 | 0.2 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen SFU | 0.80 mmol/L | Standard Deviation 1.19 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 1 | 0.12 mmol/L | Standard Deviation 0.82 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium SFU | 0.110 mmol/L | Standard Deviation 0.295 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 1 | -0.06 mmol/L | Standard Deviation 0.54 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 8 | 0.22 mmol/L | Standard Deviation 1.48 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 12 | 0.007 mmol/L | Standard Deviation 0.074 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 2 | 0.03 mmol/L | Standard Deviation 0.63 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 4 | 0.04 mmol/L | Standard Deviation 0.63 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 8 | -0.023 mmol/L | Standard Deviation 0.042 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 6 | -0.02 mmol/L | Standard Deviation 0.73 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 6 | 0.009 mmol/L | Standard Deviation 0.079 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 6 | -0.014 mmol/L | Standard Deviation 0.053 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 6 | 0.30 mmol/L | Standard Deviation 1.15 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 8 | 0.001 mmol/L | Standard Deviation 0.106 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 12 | 0.025 mmol/L | Standard Deviation 0.092 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 4 | 0.25 mmol/L | Standard Deviation 1.22 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium SFU | -0.050 mmol/L | Standard Deviation 0.109 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 4 | 0.48 mmol/L | Standard Deviation 1.52 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 2 | 0.17 mmol/L | Standard Deviation 1.23 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 6 | 0.21 mmol/L | Standard Deviation 1.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 8 | 0.14 mmol/L | Standard Deviation 1.33 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 2 | 0.08 mmol/L | Standard Deviation 0.33 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol SFU | -0.83 mmol/L | Standard Deviation 1.56 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 12 | -0.04 mmol/L | Standard Deviation 1.37 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose SFU | 0.75 mmol/L | Standard Deviation 0.89 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 1 | 0.6 mmol/L | Standard Deviation 2 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 2 | 0.1 mmol/L | Standard Deviation 2.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 12 | -0.07 mmol/L | Standard Deviation 0.62 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 4 | 0.8 mmol/L | Standard Deviation 2.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 8 | -0.17 mmol/L | Standard Deviation 0.68 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 6 | 0.0 mmol/L | Standard Deviation 2.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 1 | 0.011 mmol/L | Standard Deviation 0.088 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 8 | 0.3 mmol/L | Standard Deviation 2.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 2 | -0.03 mmol/L | Standard Deviation 1.25 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 12 | -0.1 mmol/L | Standard Deviation 2.5 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride SFU | 3.0 mmol/L | Standard Deviation 2.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 1 | 0.11 mmol/L | Standard Deviation 1.12 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 1 | 0.08 mmol/L | Standard Deviation 0.33 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 12 | 0.01 mmol/L | Standard Deviation 1.08 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium SFU | 0.8 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 4 | 0.12 mmol/L | Standard Deviation 0.41 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 2 | 0.034 mmol/L | Standard Deviation 0.094 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 12 | -0.2 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 6 | 0.11 mmol/L | Standard Deviation 0.35 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 8 | 0.0 mmol/L | Standard Deviation 2.8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 8 | 0.07 mmol/L | Standard Deviation 0.36 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 12 | 0.08 mmol/L | Standard Deviation 0.34 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 6 | -0.1 mmol/L | Standard Deviation 2.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium SFU | 0.10 mmol/L | Standard Deviation 0.37 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 4 | 0.2 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 1 | -0.002 mmol/L | Standard Deviation 0.052 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 2 | -0.004 mmol/L | Standard Deviation 0.064 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 4 | 0.012 mmol/L | Standard Deviation 0.099 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 2 | -0.2 mmol/L | Standard Deviation 1.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 4 | -0.004 mmol/L | Standard Deviation 0.062 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 2 | -0.05 mmol/L | Standard Deviation 0.92 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium SFU | -0.073 mmol/L | Standard Deviation 0.045 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen SFU | 0.78 mmol/L | Standard Deviation 3.27 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 1 | 0.05 mmol/L | Standard Deviation 0.41 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 8 | -0.023 mmol/L | Standard Deviation 0.063 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium SFU | -2.0 mmol/L | Standard Deviation 2.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium SFU | -0.035 mmol/L | Standard Deviation 0.047 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 2 | 0.02 mmol/L | Standard Deviation 0.32 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose SFU | -0.33 mmol/L | Standard Deviation 0.67 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 12 | -0.038 mmol/L | Standard Deviation 0.12 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 12 | -0.1 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 4 | -0.12 mmol/L | Standard Deviation 1.03 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 1 | -0.020 mmol/L | Standard Deviation 0.069 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 4 | 0.09 mmol/L | Standard Deviation 0.38 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 2 | 0.12 mmol/L | Standard Deviation 0.58 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 12 | -0.025 mmol/L | Standard Deviation 0.069 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 8 | -0.027 mmol/L | Standard Deviation 0.099 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 6 | -0.04 mmol/L | Standard Deviation 1.26 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 2 | -0.4 mmol/L | Standard Deviation 1.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 6 | -0.03 mmol/L | Standard Deviation 0.31 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 2 | -0.007 mmol/L | Standard Deviation 0.092 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 8 | -0.2 mmol/L | Standard Deviation 1.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 1 | 0.00 mmol/L | Standard Deviation 0.65 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 8 | 0.12 mmol/L | Standard Deviation 0.38 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 1 | 0.3 mmol/L | Standard Deviation 2.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 1 | -0.14 mmol/L | Standard Deviation 1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 6 | -0.8 mmol/L | Standard Deviation 1.6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 6 | -0.019 mmol/L | Standard Deviation 0.091 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 2 | -0.010 mmol/L | Standard Deviation 0.065 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 12 | 0.08 mmol/L | Standard Deviation 0.37 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 4 | 0.0 mmol/L | Standard Deviation 2.5 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 8 | 0.16 mmol/L | Standard Deviation 0.64 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 6 | -0.013 mmol/L | Standard Deviation 0.057 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 2 | -0.3 mmol/L | Standard Deviation 2.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 4 | -0.017 mmol/L | Standard Deviation 0.046 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 6 | -0.6 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 6 | 0.17 mmol/L | Standard Deviation 0.56 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 12 | 0.11 mmol/L | Standard Deviation 0.62 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 1 | 0.6 mmol/L | Standard Deviation 2.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 12 | 0.39 mmol/L | Standard Deviation 1.14 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 4 | 0.17 mmol/L | Standard Deviation 0.55 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 8 | 0.3 mmol/L | Standard Deviation 2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 1 | -0.021 mmol/L | Standard Deviation 0.126 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 2 | 0.24 mmol/L | Standard Deviation 1.16 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 4 | -0.020 mmol/L | Standard Deviation 0.106 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol SFU | 0.38 mmol/L | Standard Deviation 0.52 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium SFU | -0.10 mmol/L | Standard Deviation 0.29 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 12 | -0.2 mmol/L | Standard Deviation 2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 8 | 0.32 mmol/L | Standard Deviation 1.08 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 4 | 0.50 mmol/L | Standard Deviation 1.31 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 1 | 0.27 mmol/L | Standard Deviation 1.19 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 6 | 0.41 mmol/L | Standard Deviation 1.14 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 8 | -0.15 mmol/L | Standard Deviation 0.87 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride SFU | 0.5 mmol/L | Standard Deviation 5.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 12 | 0.02 mmol/L | Standard Deviation 1.35 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 4 | 0.2 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose SFU | -0.25 mmol/L | Standard Deviation 0.49 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 4 | -0.03 mmol/L | Standard Deviation 1.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 1 | -0.017 mmol/L | Standard Deviation 0.076 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 2 | 0.004 mmol/L | Standard Deviation 0.074 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 4 | -0.008 mmol/L | Standard Deviation 0.074 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 6 | -0.008 mmol/L | Standard Deviation 0.092 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 8 | 0.019 mmol/L | Standard Deviation 0.089 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 12 | 0.001 mmol/L | Standard Deviation 0.093 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium SFU | -0.125 mmol/L | Standard Deviation 0.134 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 6 | 0.19 mmol/L | Standard Deviation 1.31 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 8 | -0.08 mmol/L | Standard Deviation 1.58 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 12 | 0.08 mmol/L | Standard Deviation 1.13 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 1 | 0.6 mmol/L | Standard Deviation 2.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 2 | 0.4 mmol/L | Standard Deviation 2.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 4 | 0.2 mmol/L | Standard Deviation 2.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 6 | 0.0 mmol/L | Standard Deviation 2.4 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 8 | -0.1 mmol/L | Standard Deviation 2.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 12 | 0.2 mmol/L | Standard Deviation 2.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride SFU | 2.0 mmol/L | Standard Deviation 0 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 1 | 0.02 mmol/L | Standard Deviation 0.36 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 2 | -0.06 mmol/L | Standard Deviation 0.29 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 4 | 0.01 mmol/L | Standard Deviation 0.34 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 6 | -0.07 mmol/L | Standard Deviation 0.33 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 8 | -0.06 mmol/L | Standard Deviation 0.38 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 12 | -0.06 mmol/L | Standard Deviation 0.37 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium SFU | -0.45 mmol/L | Standard Deviation 0.07 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 1 | 0.005 mmol/L | Standard Deviation 0.079 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 2 | 0.001 mmol/L | Standard Deviation 0.068 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 4 | 0.008 mmol/L | Standard Deviation 0.071 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen SFU | -0.65 mmol/L | Standard Deviation 2.05 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 1 | -0.09 mmol/L | Standard Deviation 0.59 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 2 | -0.11 mmol/L | Standard Deviation 0.52 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 4 | -0.31 mmol/L | Standard Deviation 0.88 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 6 | -0.24 mmol/L | Standard Deviation 0.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 6 | -0.008 mmol/L | Standard Deviation 0.065 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 8 | 0.003 mmol/L | Standard Deviation 0.071 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 12 | 0.009 mmol/L | Standard Deviation 0.074 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium SFU | -0.050 mmol/L | Standard Deviation 0.057 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 1 | 0.1 mmol/L | Standard Deviation 1.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 2 | 0.0 mmol/L | Standard Deviation 2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 4 | -0.2 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 6 | -0.1 mmol/L | Standard Deviation 1.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 8 | -0.2 mmol/L | Standard Deviation 2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 12 | -0.2 mmol/L | Standard Deviation 2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium SFU | -2.0 mmol/L | Standard Deviation 2.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 1 | 0.34 mmol/L | Standard Deviation 1.22 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 2 | 0.16 mmol/L | Standard Deviation 1.17 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 8 | -0.13 mmol/L | Standard Deviation 0.83 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 12 | -0.18 mmol/L | Standard Deviation 0.77 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol SFU | -0.80 mmol/L | Standard Deviation 0.14 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 1 | -0.06 mmol/L | Standard Deviation 1.14 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 2 | -0.20 mmol/L | Standard Deviation 1.13 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 4 | -0.09 mmol/L | Standard Deviation 1.24 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 6 | 0.02 mmol/L | Standard Deviation 1.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 8 | -0.06 mmol/L | Standard Deviation 1.43 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 12 | -0.17 mmol/L | Standard Deviation 1.23 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 12 | 0.13 mmol/L | Standard Deviation 1.08 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 4 | -0.017 mmol/L | Standard Deviation 0.067 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 6 | 0.21 mmol/L | Standard Deviation 1.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 1 | 0.0 mmol/L | Standard Deviation 2.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 2 | -0.017 mmol/L | Standard Deviation 0.086 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 2 | 0.2 mmol/L | Standard Deviation 2.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 1 | -0.007 mmol/L | Standard Deviation 0.077 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium SFU | 0.20 mmol/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 4 | -0.1 mmol/L | Standard Deviation 2.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 12 | -0.07 mmol/L | Standard Deviation 0.37 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 4 | 0.005 mmol/L | Standard Deviation 0.099 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 6 | -0.1 mmol/L | Standard Deviation 2.9 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 8 | -0.12 mmol/L | Standard Deviation 0.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 6 | -0.07 mmol/L | Standard Deviation 0.34 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 8 | -0.1 mmol/L | Standard Deviation 2.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 4 | 0.05 mmol/L | Standard Deviation 0.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 12 | -0.2 mmol/L | Standard Deviation 2.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 2 | 0.05 mmol/L | Standard Deviation 0.37 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 1 | -0.03 mmol/L | Standard Deviation 0.32 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 8 | 0.11 mmol/L | Standard Deviation 1.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium SFU | -1.0 mmol/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride SFU | 0.0 mmol/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 1 | 0.27 mmol/L | Standard Deviation 1.24 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 12 | 0.8 mmol/L | Standard Deviation 2.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 8 | 0.1 mmol/L | Standard Deviation 2.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 2 | 0.006 mmol/L | Standard Deviation 0.088 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 2 | 0.27 mmol/L | Standard Deviation 1.17 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 6 | -0.24 mmol/L | Standard Deviation 1.32 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 6 | -0.1 mmol/L | Standard Deviation 3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 4 | -0.1 mmol/L | Standard Deviation 2.6 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 8 | -0.17 mmol/L | Standard Deviation 1.22 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 2 | 0.5 mmol/L | Standard Deviation 2.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 1 | 0.000 mmol/L | Standard Deviation 0.077 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 12 | 0.01 mmol/L | Standard Deviation 1.29 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 1 | 0.3 mmol/L | Standard Deviation 2.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 8 | 0.33 mmol/L | Standard Deviation 1.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose SFU | 0.20 mmol/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol SFU | 0.20 mmol/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 12 | -0.15 mmol/L | Standard Deviation 0.88 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 1 | 0.07 mmol/L | Standard Deviation 1.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 6 | 0.29 mmol/L | Standard Deviation 1.14 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium SFU | 0.020 mmol/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 2 | 0.03 mmol/L | Standard Deviation 1.09 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 12 | -0.019 mmol/L | Standard Deviation 0.121 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 4 | 0.37 mmol/L | Standard Deviation 1.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 8 | -0.002 mmol/L | Standard Deviation 0.089 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 6 | -0.020 mmol/L | Standard Deviation 0.073 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 4 | 0.00 mmol/L | Standard Deviation 1.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 8 | -0.019 mmol/L | Standard Deviation 0.072 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 2 | 0.12 mmol/L | Standard Deviation 1.04 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 1 | 0.12 mmol/L | Standard Deviation 0.65 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 6 | -0.026 mmol/L | Standard Deviation 0.086 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 12 | -0.017 mmol/L | Standard Deviation 0.075 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen SFU | -0.30 mmol/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 4 | -0.11 mmol/L | Standard Deviation 1.08 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium SFU | -0.060 mmol/L | — |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 12 | -0.001 mmol/L | Standard Deviation 0.092 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 4 | -0.1 mmol/L | Standard Deviation 1.9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen SFU | 0.77 mmol/L | Standard Deviation 1.27 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 1 | -0.010 mmol/L | Standard Deviation 0.08 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 1 | 0.0 mmol/L | Standard Deviation 1.4 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 2 | 0.005 mmol/L | Standard Deviation 0.075 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 8 | -0.016 mmol/L | Standard Deviation 0.084 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 1 | -0.009 mmol/L | Standard Deviation 0.064 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 6 | 0.29 mmol/L | Standard Deviation 1.27 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 8 | 0.01 mmol/L | Standard Deviation 0.48 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 2 | 0.0 mmol/L | Standard Deviation 1.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 2 | 0.1 mmol/L | Standard Deviation 1.9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium SFU | -0.20 mmol/L | Standard Deviation 0.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 4 | 0.15 mmol/L | Standard Deviation 1.04 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 4 | -0.010 mmol/L | Standard Deviation 0.084 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 1 | 0.1 mmol/L | Standard Deviation 1.8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 4 | -0.2 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 12 | -0.06 mmol/L | Standard Deviation 0.33 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 1 | 0.06 mmol/L | Standard Deviation 0.34 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 8 | 0.02 mmol/L | Standard Deviation 0.35 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 4 | 0.19 mmol/L | Standard Deviation 0.92 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 12 | -0.05 mmol/L | Standard Deviation 0.76 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 6 | -0.3 mmol/L | Standard Deviation 1.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 4 | -0.013 mmol/L | Standard Deviation 0.07 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 6 | -0.02 mmol/L | Standard Deviation 0.35 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 8 | 0.35 mmol/L | Standard Deviation 0.88 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 2 | -0.006 mmol/L | Standard Deviation 0.085 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 12 | 0.01 mmol/L | Standard Deviation 0.85 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 8 | -0.6 mmol/L | Standard Deviation 2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 4 | 0.03 mmol/L | Standard Deviation 0.33 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 6 | -0.017 mmol/L | Standard Deviation 0.063 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 2 | -0.03 mmol/L | Standard Deviation 0.39 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose SFU | -0.17 mmol/L | Standard Deviation 0.61 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 4 | 0.05 mmol/L | Standard Deviation 0.66 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium Week 12 | -0.3 mmol/L | Standard Deviation 1.9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol SFU | 0.40 mmol/L | Standard Deviation 0.44 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Potassium Week 1 | 0.04 mmol/L | Standard Deviation 0.29 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 6 | 0.12 mmol/L | Standard Deviation 0.93 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium SFU | -0.023 mmol/L | Standard Deviation 0.025 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 2 | 0.05 mmol/L | Standard Deviation 0.57 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Sodium SFU | -1.7 mmol/L | Standard Deviation 1.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride SFU | 0.3 mmol/L | Standard Deviation 2.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 1 | 0.22 mmol/L | Standard Deviation 0.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 12 | 0.1 mmol/L | Standard Deviation 2.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 8 | 0.03 mmol/L | Standard Deviation 0.97 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium Week 6 | -0.027 mmol/L | Standard Deviation 0.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 1 | 0.21 mmol/L | Standard Deviation 0.88 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Calcium SFU | 0.020 mmol/L | Standard Deviation 0.193 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 8 | 0.1 mmol/L | Standard Deviation 2.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 12 | -0.008 mmol/L | Standard Deviation 0.056 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 12 | 0.04 mmol/L | Standard Deviation 0.95 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Magnesium Week 8 | -0.021 mmol/L | Standard Deviation 0.058 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Urea Nitrogen Week 2 | 0.37 mmol/L | Standard Deviation 1.03 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Chloride Week 6 | 0.1 mmol/L | Standard Deviation 2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Glucose Week 2 | 0.05 mmol/L | Standard Deviation 0.67 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Calcium, Chloride, Potassium, Magnesium, Sodium, Urea Nitrogen, Cholesterol, Glucose) | Cholesterol Week 6 | 0.08 mmol/L | Standard Deviation 0.6 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein)
C Reactive Protein was measured in milligrams per liters (mg/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 4 | 1.338 mg/L | Standard Deviation 11.182 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 2 | 1.821 mg/L | Standard Deviation 6.974 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | SFU | 8.000 mg/L | — |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 8 | 3.153 mg/L | Standard Deviation 18.764 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 6 | 2.978 mg/L | Standard Deviation 13.162 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 12 | 7.279 mg/L | Standard Deviation 13.546 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 1 | -2.110 mg/L | Standard Deviation 5.255 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 1 | -5.367 mg/L | Standard Deviation 11.806 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 4 | -5.835 mg/L | Standard Deviation 8.594 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 12 | -5.193 mg/L | Standard Deviation 10.817 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 2 | -6.985 mg/L | Standard Deviation 11.064 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 6 | -5.930 mg/L | Standard Deviation 9.56 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 8 | -6.891 mg/L | Standard Deviation 15.192 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 6 | -4.516 mg/L | Standard Deviation 11.304 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 8 | -3.143 mg/L | Standard Deviation 10.844 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 1 | -0.775 mg/L | Standard Deviation 2.02 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 4 | -1.722 mg/L | Standard Deviation 5.596 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 12 | 0.695 mg/L | Standard Deviation 6.381 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 2 | 0.576 mg/L | Standard Deviation 2.898 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 1 | -2.635 mg/L | Standard Deviation 2.55 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 8 | 2.590 mg/L | Standard Deviation 7.755 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 4 | 0.929 mg/L | Standard Deviation 8.047 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 2 | 2.743 mg/L | Standard Deviation 15.212 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 6 | -0.595 mg/L | Standard Deviation 7.346 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 12 | -3.033 mg/L | Standard Deviation 7.261 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 12 | -9.890 mg/L | Standard Deviation 10.729 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 6 | 1.799 mg/L | Standard Deviation 14.635 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 8 | 12.434 mg/L | Standard Deviation 47.447 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 4 | -4.226 mg/L | Standard Deviation 9.865 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 1 | -5.108 mg/L | Standard Deviation 10.013 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 2 | -6.763 mg/L | Standard Deviation 13.211 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 2 | -3.042 mg/L | Standard Deviation 1.989 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 1 | -3.732 mg/L | Standard Deviation 3.997 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 12 | -5.368 mg/L | Standard Deviation 5.322 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 8 | -1.104 mg/L | Standard Deviation 5.201 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 6 | -6.598 mg/L | Standard Deviation 6.278 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (C Reactive Protein) | Week 4 | 7.141 mg/L | Standard Deviation 32.344 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin)
Creatinine and bilirubin were measured in micromols per liter (μmol/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine SFU | 1.5 μmol/L | Standard Deviation 4.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 8 | -1.1 μmol/L | Standard Deviation 6.2 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin SFU | 2.05 μmol/L | Standard Deviation 2.16 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 12 | -1.6 μmol/L | Standard Deviation 7.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 1 | 0.6 μmol/L | Standard Deviation 7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 8 | -0.21 μmol/L | Standard Deviation 3.81 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 6 | -0.51 μmol/L | Standard Deviation 3.13 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 2 | 0.0 μmol/L | Standard Deviation 7.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 12 | -0.74 μmol/L | Standard Deviation 3.43 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 4 | -0.70 μmol/L | Standard Deviation 3.26 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 4 | 0.0 μmol/L | Standard Deviation 5.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 2 | -0.35 μmol/L | Standard Deviation 2.85 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 1 | -0.53 μmol/L | Standard Deviation 3.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 6 | -1.1 μmol/L | Standard Deviation 7.8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 1 | -1.79 μmol/L | Standard Deviation 4.5 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 12 | -0.2 μmol/L | Standard Deviation 7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 4 | -1.70 μmol/L | Standard Deviation 4.92 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 8 | -0.4 μmol/L | Standard Deviation 7.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 8 | -0.98 μmol/L | Standard Deviation 4.68 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 2 | -0.86 μmol/L | Standard Deviation 5.05 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine SFU | 6.0 μmol/L | Standard Deviation 4.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 1 | 2.7 μmol/L | Standard Deviation 10.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin SFU | -1.23 μmol/L | Standard Deviation 2.62 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 4 | 1.3 μmol/L | Standard Deviation 9.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 6 | -1.15 μmol/L | Standard Deviation 4.59 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 12 | -1.02 μmol/L | Standard Deviation 5.24 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 6 | 1.6 μmol/L | Standard Deviation 10.5 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 2 | -0.8 μmol/L | Standard Deviation 8.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 4 | 0.6 μmol/L | Standard Deviation 7.9 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 12 | -0.73 μmol/L | Standard Deviation 2.98 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 1 | 1.4 μmol/L | Standard Deviation 8.6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 2 | -0.4 μmol/L | Standard Deviation 10.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 6 | -0.1 μmol/L | Standard Deviation 10.6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 8 | -1.0 μmol/L | Standard Deviation 9.6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 12 | 0.7 μmol/L | Standard Deviation 12 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine SFU | -6.5 μmol/L | Standard Deviation 4.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 1 | -0.52 μmol/L | Standard Deviation 2.81 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 2 | -0.48 μmol/L | Standard Deviation 3.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 4 | -0.26 μmol/L | Standard Deviation 3.53 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 6 | 0.35 μmol/L | Standard Deviation 3.44 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 8 | -0.30 μmol/L | Standard Deviation 3.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin SFU | -0.30 μmol/L | Standard Deviation 3.87 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 12 | -1.20 μmol/L | Standard Deviation 3.37 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 2 | -0.38 μmol/L | Standard Deviation 3.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 8 | -2.6 μmol/L | Standard Deviation 8.4 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin SFU | -0.25 μmol/L | Standard Deviation 0.78 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 8 | -0.43 μmol/L | Standard Deviation 4.52 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 2 | -0.7 μmol/L | Standard Deviation 8.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 4 | -0.04 μmol/L | Standard Deviation 2.74 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 12 | -0.7 μmol/L | Standard Deviation 9.1 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine SFU | -10.5 μmol/L | Standard Deviation 16.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 1 | -0.55 μmol/L | Standard Deviation 4.49 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 6 | -0.6 μmol/L | Standard Deviation 7.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 1 | 0.6 μmol/L | Standard Deviation 8.1 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 4 | -1.7 μmol/L | Standard Deviation 8.1 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 6 | -0.33 μmol/L | Standard Deviation 3.94 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 6 | -0.1 μmol/L | Standard Deviation 8.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine SFU | 9.0 μmol/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 4 | 0.6 μmol/L | Standard Deviation 8.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 12 | -0.43 μmol/L | Standard Deviation 3.68 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 1 | 0.57 μmol/L | Standard Deviation 5.73 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 2 | -0.99 μmol/L | Standard Deviation 2.98 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 2 | -0.1 μmol/L | Standard Deviation 8.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 4 | 0.76 μmol/L | Standard Deviation 4.27 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 1 | 0.7 μmol/L | Standard Deviation 8.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 6 | 0.11 μmol/L | Standard Deviation 4.19 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin SFU | -1.50 μmol/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 8 | -0.1 μmol/L | Standard Deviation 7.6 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 8 | -0.15 μmol/L | Standard Deviation 3.79 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 12 | 0.1 μmol/L | Standard Deviation 9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 6 | -0.5 μmol/L | Standard Deviation 11.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 6 | -0.30 μmol/L | Standard Deviation 4.28 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 1 | 0.14 μmol/L | Standard Deviation 4.16 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 12 | -0.34 μmol/L | Standard Deviation 3.45 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 12 | -0.7 μmol/L | Standard Deviation 7.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 4 | 1.6 μmol/L | Standard Deviation 7.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 8 | -0.02 μmol/L | Standard Deviation 4.41 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin SFU | 1.40 μmol/L | Standard Deviation 2.96 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 8 | 0.1 μmol/L | Standard Deviation 8.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 4 | 0.70 μmol/L | Standard Deviation 4.52 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 1 | -0.7 μmol/L | Standard Deviation 7.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine SFU | 1.3 μmol/L | Standard Deviation 6.4 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Bilirubin Week 2 | 0.27 μmol/L | Standard Deviation 3.69 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Creatinine, Bilirubin) | Creatinine Week 2 | 0.0 μmol/L | Standard Deviation 7.1 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase)
Lactate dehydrogenase, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase were measured in units per liter (U/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 6 | 3.9 U/L | Standard Deviation 18.9 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase SFU | -2.8 U/L | Standard Deviation 1.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 4 | -0.2 U/L | Standard Deviation 7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 6 | 1.8 U/L | Standard Deviation 10.5 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 8 | 0.0 U/L | Standard Deviation 5.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 1 | 0.5 U/L | Standard Deviation 6.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 8 | 1.8 U/L | Standard Deviation 10.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 4 | -0.7 U/L | Standard Deviation 8.5 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase SFU | -0.5 U/L | Standard Deviation 7.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 2 | 0.3 U/L | Standard Deviation 6.5 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 12 | -1.3 U/L | Standard Deviation 7.5 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 1 | -2.0 U/L | Standard Deviation 29.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase SFU | -3.8 U/L | Standard Deviation 3 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 8 | 2.4 U/L | Standard Deviation 13.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 1 | -1.8 U/L | Standard Deviation 6.3 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 12 | -4.9 U/L | Standard Deviation 28.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 6 | 1.5 U/L | Standard Deviation 10.6 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 4 | -2.4 U/L | Standard Deviation 8.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 2 | -3.0 U/L | Standard Deviation 12.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase SFU | -8.0 U/L | Standard Deviation 13.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 12 | -2.0 U/L | Standard Deviation 8.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 4 | -1.1 U/L | Standard Deviation 4.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 2 | -4.9 U/L | Standard Deviation 26.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 4 | -4.9 U/L | Standard Deviation 22.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase SFU | -1.5 U/L | Standard Deviation 12.9 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 1 | 2.0 U/L | Standard Deviation 7.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 1 | 0.6 U/L | Standard Deviation 6.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 8 | -4.3 U/L | Standard Deviation 12.2 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 12 | -0.4 U/L | Standard Deviation 10.9 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 6 | -5.0 U/L | Standard Deviation 27.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 6 | -3.0 U/L | Standard Deviation 8.3 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 2 | -1.0 U/L | Standard Deviation 3.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 2 | 0.2 U/L | Standard Deviation 8.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 12 | -1.3 U/L | Standard Deviation 5.5 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 8 | -5.5 U/L | Standard Deviation 27.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 8 | 0.2 U/L | Standard Deviation 6.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 12 | 2.9 U/L | Standard Deviation 26.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 1 | 2.1 U/L | Standard Deviation 10.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase SFU | -5.0 U/L | Standard Deviation 18.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 4 | 1.7 U/L | Standard Deviation 31.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 1 | -0.5 U/L | Standard Deviation 6 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 2 | 0.0 U/L | Standard Deviation 7.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 6 | -1.8 U/L | Standard Deviation 9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 2 | -2.5 U/L | Standard Deviation 25.2 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 1 | -0.8 U/L | Standard Deviation 14.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 2 | -1.6 U/L | Standard Deviation 11.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 6 | 1.1 U/L | Standard Deviation 8.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 6 | -1.8 U/L | Standard Deviation 13.8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 12 | 1.8 U/L | Standard Deviation 9.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 2 | 1.9 U/L | Standard Deviation 9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase SFU | 9.8 U/L | Standard Deviation 8.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase SFU | 4.3 U/L | Standard Deviation 3.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 8 | -1.9 U/L | Standard Deviation 14.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 1 | 2.0 U/L | Standard Deviation 10.8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 6 | -1.4 U/L | Standard Deviation 25.2 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 4 | -1.9 U/L | Standard Deviation 11.8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 4 | 1.1 U/L | Standard Deviation 8.6 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 8 | 0.5 U/L | Standard Deviation 25.2 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 4 | -1.9 U/L | Standard Deviation 9.2 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 2 | 0.4 U/L | Standard Deviation 4.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 12 | 0.3 U/L | Standard Deviation 7.2 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 4 | -0.1 U/L | Standard Deviation 5.8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 12 | -2.2 U/L | Standard Deviation 13.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 6 | 0.8 U/L | Standard Deviation 6 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 8 | 2.2 U/L | Standard Deviation 10.2 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase SFU | 1.3 U/L | Standard Deviation 3.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 1 | 1.1 U/L | Standard Deviation 24.8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 12 | 1.1 U/L | Standard Deviation 7.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 8 | -1.7 U/L | Standard Deviation 8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase SFU | -0.3 U/L | Standard Deviation 2.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase SFU | 19.8 U/L | Standard Deviation 23.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 12 | -2.4 U/L | Standard Deviation 11.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 4 | -6.2 U/L | Standard Deviation 9.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase SFU | 11.5 U/L | Standard Deviation 23.5 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 2 | -1.9 U/L | Standard Deviation 19.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 1 | -2.0 U/L | Standard Deviation 10.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 4 | 0.8 U/L | Standard Deviation 18.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 8 | -4.2 U/L | Standard Deviation 11.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 8 | 0.1 U/L | Standard Deviation 10.5 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase SFU | 3.3 U/L | Standard Deviation 81.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 4 | -2.5 U/L | Standard Deviation 17.5 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 12 | -7.5 U/L | Standard Deviation 25.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 12 | -1.1 U/L | Standard Deviation 21.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 2 | -2.5 U/L | Standard Deviation 10.5 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 1 | -3.5 U/L | Standard Deviation 8.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 12 | -1.4 U/L | Standard Deviation 8.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 12 | -1.0 U/L | Standard Deviation 10.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 6 | -0.9 U/L | Standard Deviation 9.5 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase SFU | 26.5 U/L | Standard Deviation 42.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 1 | -1.7 U/L | Standard Deviation 13.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase SFU | 7.8 U/L | Standard Deviation 15.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 2 | -3.5 U/L | Standard Deviation 22.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 6 | -2.9 U/L | Standard Deviation 13.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 6 | -5.5 U/L | Standard Deviation 10 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 1 | -3.0 U/L | Standard Deviation 15.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 8 | -0.9 U/L | Standard Deviation 18.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 6 | -0.6 U/L | Standard Deviation 11.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 2 | 2.0 U/L | Standard Deviation 29.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 6 | -7.3 U/L | Standard Deviation 20.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 4 | -8.1 U/L | Standard Deviation 16.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 1 | -5.0 U/L | Standard Deviation 24.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 4 | 1.8 U/L | Standard Deviation 18.6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 2 | 0.2 U/L | Standard Deviation 14.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 8 | -1.4 U/L | Standard Deviation 5.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 8 | -12.3 U/L | Standard Deviation 22.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 1 | -3.8 U/L | Standard Deviation 7.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 4 | -2.6 U/L | Standard Deviation 12.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 6 | -2.9 U/L | Standard Deviation 7.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 8 | -2.6 U/L | Standard Deviation 13.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 2 | 0.4 U/L | Standard Deviation 27.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase SFU | -16.5 U/L | Standard Deviation 24.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 12 | -0.6 U/L | Standard Deviation 11.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 4 | 5.0 U/L | Standard Deviation 43.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 6 | 3.5 U/L | Standard Deviation 20.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase SFU | -4.0 U/L | Standard Deviation 2.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase SFU | -3.0 U/L | Standard Deviation 5.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 8 | -0.4 U/L | Standard Deviation 9.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 2 | -0.9 U/L | Standard Deviation 7.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 12 | -0.9 U/L | Standard Deviation 9.1 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase SFU | -6.0 U/L | Standard Deviation 8.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 1 | 1.9 U/L | Standard Deviation 11.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 6 | 2.0 U/L | Standard Deviation 16.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 12 | -0.4 U/L | Standard Deviation 9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 8 | -0.8 U/L | Standard Deviation 18.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 2 | -0.9 U/L | Standard Deviation 4.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 4 | -0.4 U/L | Standard Deviation 5.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 4 | -0.4 U/L | Standard Deviation 10.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 6 | 4.0 U/L | Standard Deviation 15.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 8 | -2.1 U/L | Standard Deviation 10 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 8 | -1.4 U/L | Standard Deviation 4.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 12 | -0.3 U/L | Standard Deviation 4.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 1 | -0.3 U/L | Standard Deviation 21.4 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 12 | -0.3 U/L | Standard Deviation 20.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 6 | -2.4 U/L | Standard Deviation 8.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase SFU | -45.5 U/L | Standard Deviation 16.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 1 | 1.6 U/L | Standard Deviation 12.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 2 | -1.2 U/L | Standard Deviation 8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 2 | -2.7 U/L | Standard Deviation 8.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 4 | -4.3 U/L | Standard Deviation 9.4 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 1 | -7.5 U/L | Standard Deviation 42.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 2 | -0.2 U/L | Standard Deviation 10.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 2 | -1.9 U/L | Standard Deviation 6.5 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 1 | -4.6 U/L | Standard Deviation 18.9 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 4 | 0.4 U/L | Standard Deviation 14.7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 2 | -7.6 U/L | Standard Deviation 27.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 4 | -4.5 U/L | Standard Deviation 37.7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 6 | -1.7 U/L | Standard Deviation 13.7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 8 | -1.1 U/L | Standard Deviation 14.5 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 12 | -0.9 U/L | Standard Deviation 14.6 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase SFU | 16.0 U/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 1 | 0.3 U/L | Standard Deviation 6.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 6 | -11.0 U/L | Standard Deviation 27.5 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 2 | -0.5 U/L | Standard Deviation 6.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 4 | 0.6 U/L | Standard Deviation 8.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 6 | -1.4 U/L | Standard Deviation 7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 8 | -0.4 U/L | Standard Deviation 8.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 12 | -0.5 U/L | Standard Deviation 7.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 8 | -10.7 U/L | Standard Deviation 33.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 12 | -5.6 U/L | Standard Deviation 33.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase SFU | 15.0 U/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 2 | -1.6 U/L | Standard Deviation 6.5 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase SFU | 9.0 U/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 1 | 1.6 U/L | Standard Deviation 22.9 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 4 | -0.4 U/L | Standard Deviation 8.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 6 | -2.1 U/L | Standard Deviation 9.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 8 | -2.5 U/L | Standard Deviation 9.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 12 | -0.4 U/L | Standard Deviation 11.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase SFU | 37.0 U/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 4 | -2.6 U/L | Standard Deviation 8.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 6 | -2.1 U/L | Standard Deviation 9.6 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 8 | -1.1 U/L | Standard Deviation 11.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 12 | -0.5 U/L | Standard Deviation 10.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase SFU | 3.0 U/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 1 | 0.7 U/L | Standard Deviation 8.9 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 1 | -1.9 U/L | Standard Deviation 5.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 1 | -2.3 U/L | Standard Deviation 5.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 2 | -1.7 U/L | Standard Deviation 7.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase SFU | 32.3 U/L | Standard Deviation 34.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 12 | -4.4 U/L | Standard Deviation 24.8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 1 | 1.2 U/L | Standard Deviation 9.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 6 | -1.4 U/L | Standard Deviation 7.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 8 | -3.7 U/L | Standard Deviation 27.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 12 | -0.9 U/L | Standard Deviation 5.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 8 | -0.8 U/L | Standard Deviation 6.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 6 | -1.4 U/L | Standard Deviation 6.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 2 | 1.6 U/L | Standard Deviation 11.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 8 | -1.9 U/L | Standard Deviation 7.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 4 | -0.4 U/L | Standard Deviation 7.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 2 | 0.9 U/L | Standard Deviation 13.4 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase Week 1 | -0.5 U/L | Standard Deviation 7.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 6 | -3.5 U/L | Standard Deviation 22.6 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 6 | -1.1 U/L | Standard Deviation 12.9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 12 | -0.4 U/L | Standard Deviation 8.4 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase SFU | -3.3 U/L | Standard Deviation 3.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 12 | -0.4 U/L | Standard Deviation 10.6 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 8 | 0.8 U/L | Standard Deviation 9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 6 | 1.1 U/L | Standard Deviation 12.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase Week 4 | -1.7 U/L | Standard Deviation 7.8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alkaline Phosphatase SFU | 3.0 U/L | Standard Deviation 1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 4 | -4.4 U/L | Standard Deviation 15.4 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 2 | -5.1 U/L | Standard Deviation 20.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Alanine Aminotransferase Week 4 | 1.0 U/L | Standard Deviation 13.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 12 | -0.9 U/L | Standard Deviation 12.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 8 | 3.1 U/L | Standard Deviation 29.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Lactate Dehydrogenase Week 1 | -3.4 U/L | Standard Deviation 19.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase SFU | 3.0 U/L | Standard Deviation 3.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 4 | -1.4 U/L | Standard Deviation 14.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 2 | 0.4 U/L | Standard Deviation 15 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Gamma Glutamyl Transferase Week 1 | -0.8 U/L | Standard Deviation 6.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Biochemistry Parameters (Lactate Dehydrogenase, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase) | Aspartate Aminotransferase SFU | 0.7 U/L | Standard Deviation 2.5 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils)
Basophils, eosinophils, leukocytes, lymphocytes, monocytes and neutrophils were measured in number of white blood cells per liter (10\^9/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils SFU | -0.45 10^9 white blood cells per liter | Standard Deviation 0.79 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | 0.00 10^9 white blood cells per liter | Standard Deviation 1.37 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | 0.16 10^9 white blood cells per liter | Standard Deviation 1.3 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -0.10 10^9 white blood cells per liter | Standard Deviation 1.34 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | 0.18 10^9 white blood cells per liter | Standard Deviation 1.36 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | 0.17 10^9 white blood cells per liter | Standard Deviation 1.51 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 6 | -0.36 10^9 white blood cells per liter | Standard Deviation 0.98 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 6 | -0.22 10^9 white blood cells per liter | Standard Deviation 1.25 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | 0.04 10^9 white blood cells per liter | Standard Deviation 1.3 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils SFU | 0.05 10^9 white blood cells per liter | Standard Deviation 0.06 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | 0.09 10^9 white blood cells per liter | Standard Deviation 1.29 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 6 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.02 10^9 white blood cells per liter | Standard Deviation 1.16 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes SFU | 0.10 10^9 white blood cells per liter | Standard Deviation 0.22 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.11 10^9 white blood cells per liter | Standard Deviation 1.17 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.16 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | -0.02 10^9 white blood cells per liter | Standard Deviation 0.15 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 6 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.15 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils SFU | 0.03 10^9 white blood cells per liter | Standard Deviation 0.05 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | 0.03 10^9 white blood cells per liter | Standard Deviation 0.16 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.06 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.14 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.16 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.08 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes SFU | 0.25 10^9 white blood cells per liter | Standard Deviation 0.24 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.03 10^9 white blood cells per liter | Standard Deviation 0.09 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | 0.08 10^9 white blood cells per liter | Standard Deviation 0.38 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.37 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 6 | 0.04 10^9 white blood cells per liter | Standard Deviation 0.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -0.13 10^9 white blood cells per liter | Standard Deviation 1.18 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 6 | 0.08 10^9 white blood cells per liter | Standard Deviation 0.46 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | 0.06 10^9 white blood cells per liter | Standard Deviation 0.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.09 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | 0.08 10^9 white blood cells per liter | Standard Deviation 0.32 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.09 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.02 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | 0.12 10^9 white blood cells per liter | Standard Deviation 0.36 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes SFU | -0.05 10^9 white blood cells per liter | Standard Deviation 0.98 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.18 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils SFU | 0.08 10^9 white blood cells per liter | Standard Deviation 0.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | -0.28 10^9 white blood cells per liter | Standard Deviation 1.68 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils SFU | -0.03 10^9 white blood cells per liter | Standard Deviation 0.05 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils SFU | 0.75 10^9 white blood cells per liter | Standard Deviation 1.88 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -0.67 10^9 white blood cells per liter | Standard Deviation 1.55 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | -0.01 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 6 | -0.50 10^9 white blood cells per liter | Standard Deviation 1.95 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 6 | -0.08 10^9 white blood cells per liter | Standard Deviation 0.43 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | -0.04 10^9 white blood cells per liter | Standard Deviation 0.13 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | -0.56 10^9 white blood cells per liter | Standard Deviation 1.31 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 6 | -0.43 10^9 white blood cells per liter | Standard Deviation 1.64 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -0.36 10^9 white blood cells per liter | Standard Deviation 1.31 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.35 10^9 white blood cells per liter | Standard Deviation 1.07 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.12 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -0.59 10^9 white blood cells per liter | Standard Deviation 1.34 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 6 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.19 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.05 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | -0.01 10^9 white blood cells per liter | Standard Deviation 0.12 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.43 10^9 white blood cells per liter | Standard Deviation 1.05 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | -0.11 10^9 white blood cells per liter | Standard Deviation 0.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.55 10^9 white blood cells per liter | Standard Deviation 1.12 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | 0.03 10^9 white blood cells per liter | Standard Deviation 0.22 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 6 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.33 10^9 white blood cells per liter | Standard Deviation 1.5 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.04 10^9 white blood cells per liter | Standard Deviation 0.26 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes SFU | 0.10 10^9 white blood cells per liter | Standard Deviation 0.22 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -0.61 10^9 white blood cells per liter | Standard Deviation 1.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes SFU | 0.25 10^9 white blood cells per liter | Standard Deviation 0.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | -0.01 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | -0.04 10^9 white blood cells per liter | Standard Deviation 0.33 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.14 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.35 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | -0.03 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | -0.05 10^9 white blood cells per liter | Standard Deviation 0.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.04 10^9 white blood cells per liter | Standard Deviation 0.26 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes SFU | 1.15 10^9 white blood cells per liter | Standard Deviation 2.54 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 6 | -0.01 10^9 white blood cells per liter | Standard Deviation 0.18 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | -0.04 10^9 white blood cells per liter | Standard Deviation 0.31 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.08 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 6 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.01 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils SFU | 0.00 10^9 white blood cells per liter | Standard Deviation 0 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.07 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.08 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 6 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.08 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.08 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.09 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils SFU | 0.10 10^9 white blood cells per liter | Standard Deviation 0 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -0.15 10^9 white blood cells per liter | Standard Deviation 1.43 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | -0.22 10^9 white blood cells per liter | Standard Deviation 1.43 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -0.23 10^9 white blood cells per liter | Standard Deviation 1.38 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 6 | -0.47 10^9 white blood cells per liter | Standard Deviation 1.49 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -0.24 10^9 white blood cells per liter | Standard Deviation 1.94 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | -0.47 10^9 white blood cells per liter | Standard Deviation 1.67 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes SFU | 0.95 10^9 white blood cells per liter | Standard Deviation 1.43 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | 0.15 10^9 white blood cells per liter | Standard Deviation 0.42 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | 0.09 10^9 white blood cells per liter | Standard Deviation 0.34 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | 0.15 10^9 white blood cells per liter | Standard Deviation 0.43 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 6 | 0.03 10^9 white blood cells per liter | Standard Deviation 0.31 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.09 10^9 white blood cells per liter | Standard Deviation 0.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | 0.06 10^9 white blood cells per liter | Standard Deviation 0.38 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes SFU | 0.23 10^9 white blood cells per liter | Standard Deviation 0.19 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.15 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.14 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.15 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 6 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.15 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.16 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | -0.02 10^9 white blood cells per liter | Standard Deviation 0.15 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes SFU | 0.03 10^9 white blood cells per liter | Standard Deviation 0.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.32 10^9 white blood cells per liter | Standard Deviation 1.25 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.31 10^9 white blood cells per liter | Standard Deviation 1.33 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.39 10^9 white blood cells per liter | Standard Deviation 1.31 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 6 | -0.49 10^9 white blood cells per liter | Standard Deviation 1.38 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -0.34 10^9 white blood cells per liter | Standard Deviation 1.72 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.49 10^9 white blood cells per liter | Standard Deviation 1.5 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils SFU | 0.65 10^9 white blood cells per liter | Standard Deviation 1.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.08 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 6 | -0.54 10^9 white blood cells per liter | Standard Deviation 1.16 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | 0.13 10^9 white blood cells per liter | Standard Deviation 0.34 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | 0.04 10^9 white blood cells per liter | Standard Deviation 0.17 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | 0.09 10^9 white blood cells per liter | Standard Deviation 0.4 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | 0.08 10^9 white blood cells per liter | Standard Deviation 0.42 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 6 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.09 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 6 | 0.04 10^9 white blood cells per liter | Standard Deviation 0.43 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.11 10^9 white blood cells per liter | Standard Deviation 0.33 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils SFU | -0.95 10^9 white blood cells per liter | Standard Deviation 0.49 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | 0.07 10^9 white blood cells per liter | Standard Deviation 0.48 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.05 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -0.57 10^9 white blood cells per liter | Standard Deviation 1.28 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes SFU | 0.25 10^9 white blood cells per liter | Standard Deviation 0.21 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | 0.04 10^9 white blood cells per liter | Standard Deviation 0.1 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | 0.04 10^9 white blood cells per liter | Standard Deviation 0.15 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils SFU | 0.00 10^9 white blood cells per liter | Standard Deviation 0 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | 0.03 10^9 white blood cells per liter | Standard Deviation 0.13 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 6 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.02 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | -0.01 10^9 white blood cells per liter | Standard Deviation 0.14 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | 0.00 10^9 white blood cells per liter | Standard Deviation 0 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.57 10^9 white blood cells per liter | Standard Deviation 1.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | -0.01 10^9 white blood cells per liter | Standard Deviation 0.18 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes SFU | 0.00 10^9 white blood cells per liter | Standard Deviation 0 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 6 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.02 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.81 10^9 white blood cells per liter | Standard Deviation 1.81 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.02 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | -0.42 10^9 white blood cells per liter | Standard Deviation 1.34 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.59 10^9 white blood cells per liter | Standard Deviation 1.09 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes SFU | -0.65 10^9 white blood cells per liter | Standard Deviation 0.78 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.68 10^9 white blood cells per liter | Standard Deviation 1.02 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -0.54 10^9 white blood cells per liter | Standard Deviation 1.14 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 6 | -0.57 10^9 white blood cells per liter | Standard Deviation 1.34 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -0.63 10^9 white blood cells per liter | Standard Deviation 1.82 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -0.37 10^9 white blood cells per liter | Standard Deviation 1.55 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils SFU | 0.00 10^9 white blood cells per liter | Standard Deviation 0 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | -0.51 10^9 white blood cells per liter | Standard Deviation 1.41 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | -0.31 10^9 white blood cells per liter | Standard Deviation 1.8 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -0.45 10^9 white blood cells per liter | Standard Deviation 1.61 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.48 10^9 white blood cells per liter | Standard Deviation 1.6 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.17 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -0.36 10^9 white blood cells per liter | Standard Deviation 1.73 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | -0.04 10^9 white blood cells per liter | Standard Deviation 0.17 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils SFU | 0.00 10^9 white blood cells per liter | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | -0.50 10^9 white blood cells per liter | Standard Deviation 1.44 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | -0.01 10^9 white blood cells per liter | Standard Deviation 0.17 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 6 | -0.02 10^9 white blood cells per liter | Standard Deviation 0.22 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils SFU | 0.50 10^9 white blood cells per liter | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 6 | -0.45 10^9 white blood cells per liter | Standard Deviation 2.02 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | -0.04 10^9 white blood cells per liter | Standard Deviation 0.17 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -0.19 10^9 white blood cells per liter | Standard Deviation 1.51 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | -0.07 10^9 white blood cells per liter | Standard Deviation 0.17 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 6 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.59 10^9 white blood cells per liter | Standard Deviation 1.28 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | 0.03 10^9 white blood cells per liter | Standard Deviation 0.13 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes SFU | -0.30 10^9 white blood cells per liter | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | 0.14 10^9 white blood cells per liter | Standard Deviation 0.46 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | 0.05 10^9 white blood cells per liter | Standard Deviation 0.18 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -0.30 10^9 white blood cells per liter | Standard Deviation 1.76 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 6 | -0.50 10^9 white blood cells per liter | Standard Deviation 1.78 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.37 10^9 white blood cells per liter | Standard Deviation 1.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | 0.12 10^9 white blood cells per liter | Standard Deviation 0.34 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 6 | 0.05 10^9 white blood cells per liter | Standard Deviation 0.16 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | 0.11 10^9 white blood cells per liter | Standard Deviation 0.36 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.05 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 6 | 0.05 10^9 white blood cells per liter | Standard Deviation 0.37 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.03 10^9 white blood cells per liter | Standard Deviation 0.09 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils SFU | -0.10 10^9 white blood cells per liter | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes SFU | 0.20 10^9 white blood cells per liter | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.41 10^9 white blood cells per liter | Standard Deviation 1.64 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.15 10^9 white blood cells per liter | Standard Deviation 0.45 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | 0.14 10^9 white blood cells per liter | Standard Deviation 0.38 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes SFU | 0.00 10^9 white blood cells per liter | — |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils SFU | -0.13 10^9 white blood cells per liter | Standard Deviation 0.38 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 8 | -0.03 10^9 white blood cells per liter | Standard Deviation 0.16 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 4 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 12 | -0.39 10^9 white blood cells per liter | Standard Deviation 0.93 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 2 | -0.36 10^9 white blood cells per liter | Standard Deviation 1.13 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 1 | -0.03 10^9 white blood cells per liter | Standard Deviation 0.14 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 1 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.45 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils SFU | 0.03 10^9 white blood cells per liter | Standard Deviation 0.06 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 8 | -0.47 10^9 white blood cells per liter | Standard Deviation 0.8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 4 | -0.34 10^9 white blood cells per liter | Standard Deviation 1.24 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 6 | -0.05 10^9 white blood cells per liter | Standard Deviation 0.4 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 2 | -0.03 10^9 white blood cells per liter | Standard Deviation 0.15 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 2 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 1 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.03 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 2 | -0.46 10^9 white blood cells per liter | Standard Deviation 1.29 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 1 | -0.48 10^9 white blood cells per liter | Standard Deviation 0.9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 12 | -0.04 10^9 white blood cells per liter | Standard Deviation 0.37 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 4 | 0.02 10^9 white blood cells per liter | Standard Deviation 0.17 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 12 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes SFU | 0.30 10^9 white blood cells per liter | Standard Deviation 0.4 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 1 | -0.02 10^9 white blood cells per liter | Standard Deviation 0.12 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 4 | -0.40 10^9 white blood cells per liter | Standard Deviation 1.18 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 2 | -0.08 10^9 white blood cells per liter | Standard Deviation 0.37 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 6 | -0.03 10^9 white blood cells per liter | Standard Deviation 0.18 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 12 | -0.48 10^9 white blood cells per liter | Standard Deviation 1.09 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 8 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.05 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 6 | -0.01 10^9 white blood cells per liter | Standard Deviation 0.17 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes SFU | 0.50 10^9 white blood cells per liter | Standard Deviation 0.44 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 6 | -0.36 10^9 white blood cells per liter | Standard Deviation 1.01 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 8 | -0.02 10^9 white blood cells per liter | Standard Deviation 0.15 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Neutrophils Week 1 | -0.44 10^9 white blood cells per liter | Standard Deviation 0.76 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 6 | -0.45 10^9 white blood cells per liter | Standard Deviation 1.12 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 8 | 0.06 10^9 white blood cells per liter | Standard Deviation 0.42 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 12 | -0.03 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Lymphocytes Week 4 | 0.06 10^9 white blood cells per liter | Standard Deviation 0.36 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes Week 12 | -0.01 10^9 white blood cells per liter | Standard Deviation 0.14 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Basophils Week 6 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.04 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils SFU | 0.07 10^9 white blood cells per liter | Standard Deviation 0.06 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 4 | 0.00 10^9 white blood cells per liter | Standard Deviation 0.18 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Eosinophils Week 2 | 0.01 10^9 white blood cells per liter | Standard Deviation 0.11 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Leukocytes Week 8 | -0.45 10^9 white blood cells per liter | Standard Deviation 0.87 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils) | Monocytes SFU | -0.07 10^9 white blood cells per liter | Standard Deviation 0.21 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes)
Erythrocytes was measured in number of red blood cells per liter (10\^12/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 2 | -0.088 10^12 red blood cells per liter | Standard Deviation 0.22 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 12 | -0.007 10^12 red blood cells per liter | Standard Deviation 0.314 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 4 | -0.085 10^12 red blood cells per liter | Standard Deviation 0.274 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 1 | -0.081 10^12 red blood cells per liter | Standard Deviation 0.282 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 6 | -0.053 10^12 red blood cells per liter | Standard Deviation 0.277 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | SFU | -0.090 10^12 red blood cells per liter | Standard Deviation 0.346 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 8 | -0.062 10^12 red blood cells per liter | Standard Deviation 0.32 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 4 | 0.019 10^12 red blood cells per liter | Standard Deviation 0.217 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 8 | 0.022 10^12 red blood cells per liter | Standard Deviation 0.245 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 6 | 0.038 10^12 red blood cells per liter | Standard Deviation 0.218 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 12 | 0.092 10^12 red blood cells per liter | Standard Deviation 0.258 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 2 | 0.010 10^12 red blood cells per liter | Standard Deviation 0.193 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 1 | 0.004 10^12 red blood cells per liter | Standard Deviation 0.213 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | SFU | -0.135 10^12 red blood cells per liter | Standard Deviation 0.184 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 6 | 0.011 10^12 red blood cells per liter | Standard Deviation 0.243 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 4 | -0.018 10^12 red blood cells per liter | Standard Deviation 0.193 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 2 | 0.014 10^12 red blood cells per liter | Standard Deviation 0.215 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 12 | 0.011 10^12 red blood cells per liter | Standard Deviation 0.271 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | SFU | -0.195 10^12 red blood cells per liter | Standard Deviation 0.165 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 8 | 0.048 10^12 red blood cells per liter | Standard Deviation 0.219 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 1 | 0.047 10^12 red blood cells per liter | Standard Deviation 0.238 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 8 | 0.009 10^12 red blood cells per liter | Standard Deviation 0.224 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 2 | -0.060 10^12 red blood cells per liter | Standard Deviation 0.282 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 4 | -0.066 10^12 red blood cells per liter | Standard Deviation 0.215 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 6 | -0.019 10^12 red blood cells per liter | Standard Deviation 0.145 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 12 | -0.005 10^12 red blood cells per liter | Standard Deviation 0.297 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | SFU | -0.215 10^12 red blood cells per liter | Standard Deviation 0.035 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 1 | -0.095 10^12 red blood cells per liter | Standard Deviation 0.184 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 6 | -0.060 10^12 red blood cells per liter | Standard Deviation 0.278 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 4 | -0.053 10^12 red blood cells per liter | Standard Deviation 0.281 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 1 | -0.029 10^12 red blood cells per liter | Standard Deviation 0.259 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 2 | -0.041 10^12 red blood cells per liter | Standard Deviation 0.231 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | SFU | 0.080 10^12 red blood cells per liter | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 8 | -0.028 10^12 red blood cells per liter | Standard Deviation 0.24 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 12 | -0.036 10^12 red blood cells per liter | Standard Deviation 0.297 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 1 | -0.026 10^12 red blood cells per liter | Standard Deviation 0.178 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 12 | 0.039 10^12 red blood cells per liter | Standard Deviation 0.228 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 6 | 0.035 10^12 red blood cells per liter | Standard Deviation 0.224 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 4 | -0.015 10^12 red blood cells per liter | Standard Deviation 0.216 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | SFU | -0.123 10^12 red blood cells per liter | Standard Deviation 0.491 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 2 | -0.001 10^12 red blood cells per liter | Standard Deviation 0.232 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes) | Week 8 | 0.056 10^12 red blood cells per liter | Standard Deviation 0.238 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB))
Erythrocytes mean corpuscular hemoglobin (HGB) was measured in picograms (pg).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | -0.09 picograms (pg) | Standard Deviation 0.57 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | -0.19 picograms (pg) | Standard Deviation 0.64 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | -0.04 picograms (pg) | Standard Deviation 0.59 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | SFU | -0.33 picograms (pg) | Standard Deviation 0.79 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | -0.07 picograms (pg) | Standard Deviation 0.66 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | -0.34 picograms (pg) | Standard Deviation 0.71 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 6 | -0.17 picograms (pg) | Standard Deviation 0.64 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | 0.04 picograms (pg) | Standard Deviation 0.54 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 6 | -0.09 picograms (pg) | Standard Deviation 0.84 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | 0.10 picograms (pg) | Standard Deviation 0.84 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | 0.09 picograms (pg) | Standard Deviation 1.09 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | -0.01 picograms (pg) | Standard Deviation 0.56 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | SFU | 2.93 picograms (pg) | Standard Deviation 6.66 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | 0.09 picograms (pg) | Standard Deviation 1.53 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | -0.07 picograms (pg) | Standard Deviation 0.63 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | 0.05 picograms (pg) | Standard Deviation 0.49 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | -0.10 picograms (pg) | Standard Deviation 0.55 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | -0.16 picograms (pg) | Standard Deviation 1.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | -0.08 picograms (pg) | Standard Deviation 0.58 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 6 | -0.16 picograms (pg) | Standard Deviation 0.61 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | SFU | -0.15 picograms (pg) | Standard Deviation 0.17 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 6 | -0.11 picograms (pg) | Standard Deviation 0.47 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | 0.07 picograms (pg) | Standard Deviation 0.51 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | 0.10 picograms (pg) | Standard Deviation 0.78 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | -0.01 picograms (pg) | Standard Deviation 0.42 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | -0.16 picograms (pg) | Standard Deviation 0.64 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | -0.14 picograms (pg) | Standard Deviation 0.66 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | SFU | -0.55 picograms (pg) | Standard Deviation 0.78 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | -0.10 picograms (pg) | Standard Deviation 0.68 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | -0.03 picograms (pg) | Standard Deviation 0.6 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | SFU | 0.70 picograms (pg) | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | -0.09 picograms (pg) | Standard Deviation 0.87 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | -0.09 picograms (pg) | Standard Deviation 1.14 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 6 | -0.12 picograms (pg) | Standard Deviation 0.84 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | -0.26 picograms (pg) | Standard Deviation 0.99 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | SFU | -0.60 picograms (pg) | Standard Deviation 1.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 8 | -0.16 picograms (pg) | Standard Deviation 0.53 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 4 | 0.04 picograms (pg) | Standard Deviation 0.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 2 | 0.14 picograms (pg) | Standard Deviation 0.54 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 12 | -0.16 picograms (pg) | Standard Deviation 0.67 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 1 | 0.00 picograms (pg) | Standard Deviation 0.53 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB)) | Week 6 | -0.04 picograms (pg) | Standard Deviation 0.6 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin)
Erythrocytes mean corpuscular hemoglobin (HGB) concentration and hemoglobin were measured in grams per liter (g/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB SFU | -12.5 g/L | Standard Deviation 11 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | -1.8 g/L | Standard Deviation 9.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 6 | -2.4 g/L | Standard Deviation 7.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | 0.1 g/L | Standard Deviation 7.9 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 6 | -2.5 g/L | Standard Deviation 11 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | -2.7 g/L | Standard Deviation 8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | 0.1 g/L | Standard Deviation 8.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | -2.9 g/L | Standard Deviation 8.2 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | -0.2 g/L | Standard Deviation 9.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | -3.0 g/L | Standard Deviation 6.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | -2.2 g/L | Standard Deviation 8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -6.3 g/L | Standard Deviation 12.5 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin SFU | -4.8 g/L | Standard Deviation 7.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | -2.9 g/L | Standard Deviation 7.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | 0.1 g/L | Standard Deviation 6.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB SFU | 5.3 g/L | Standard Deviation 26.2 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -2.2 g/L | Standard Deviation 14.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | 3.2 g/L | Standard Deviation 9.6 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | 1.1 g/L | Standard Deviation 6.6 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | -2.0 g/L | Standard Deviation 10.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | 1.1 g/L | Standard Deviation 7.6 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | 0.2 g/L | Standard Deviation 8.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin SFU | 7.8 g/L | Standard Deviation 31 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 6 | 0.7 g/L | Standard Deviation 6.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | 0.8 g/L | Standard Deviation 6.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 6 | -1.7 g/L | Standard Deviation 8.6 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | 0.5 g/L | Standard Deviation 5.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | -1.4 g/L | Standard Deviation 12.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 6 | -0.5 g/L | Standard Deviation 9.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | -0.3 g/L | Standard Deviation 8.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | 1.6 g/L | Standard Deviation 9.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | -0.1 g/L | Standard Deviation 9.9 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | 0.3 g/L | Standard Deviation 10.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -1.6 g/L | Standard Deviation 9.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB SFU | -5.5 g/L | Standard Deviation 10.6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | 1.0 g/L | Standard Deviation 6.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | 0.6 g/L | Standard Deviation 6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | -0.9 g/L | Standard Deviation 6.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 6 | -0.3 g/L | Standard Deviation 6.6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | 0.8 g/L | Standard Deviation 7.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | -0.1 g/L | Standard Deviation 8.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin SFU | -6.5 g/L | Standard Deviation 4.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | -1.0 g/L | Standard Deviation 11.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | -2.1 g/L | Standard Deviation 5.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -4.5 g/L | Standard Deviation 10.1 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin SFU | -8.5 g/L | Standard Deviation 2.1 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | -1.0 g/L | Standard Deviation 8.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | -2.9 g/L | Standard Deviation 6.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 6 | -1.2 g/L | Standard Deviation 4.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB SFU | -9.5 g/L | Standard Deviation 7.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | -2.6 g/L | Standard Deviation 5.2 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | -1.5 g/L | Standard Deviation 7.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | -2.5 g/L | Standard Deviation 7.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | -0.3 g/L | Standard Deviation 9.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 6 | -2.9 g/L | Standard Deviation 7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | -0.6 g/L | Standard Deviation 7.5 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | -2.1 g/L | Standard Deviation 9.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | -1.0 g/L | Standard Deviation 7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 6 | -0.5 g/L | Standard Deviation 7.8 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | 0.5 g/L | Standard Deviation 8.6 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | -1.1 g/L | Standard Deviation 7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | -1.8 g/L | Standard Deviation 8.7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | 0.1 g/L | Standard Deviation 8 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 6 | -2.1 g/L | Standard Deviation 8.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | 2.6 g/L | Standard Deviation 7.9 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | -1.8 g/L | Standard Deviation 8.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin SFU | 6.0 g/L | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -2.0 g/L | Standard Deviation 12.7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | -1.2 g/L | Standard Deviation 9.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB SFU | -2.0 g/L | — |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 8 | -2.9 g/L | Standard Deviation 9.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 8 | 0.9 g/L | Standard Deviation 6.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 2 | 0.5 g/L | Standard Deviation 6.6 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 1 | 0.3 g/L | Standard Deviation 8.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB SFU | -22.0 g/L | Standard Deviation 18 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 6 | -1.3 g/L | Standard Deviation 8.9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 12 | 0.3 g/L | Standard Deviation 7.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin SFU | -6.7 g/L | Standard Deviation 11 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 12 | -3.6 g/L | Standard Deviation 13.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 6 | 0.9 g/L | Standard Deviation 6.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 2 | 1.8 g/L | Standard Deviation 8.8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 1 | -0.8 g/L | Standard Deviation 5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Hemoglobin Week 4 | -0.4 g/L | Standard Deviation 6.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin) | Ery. mean corpuscular HGB Week 4 | -0.4 g/L | Standard Deviation 11.7 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume)
Erythrocytes mean corpuscular volume was measured in femtolitres (fL).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 1 | -0.35 femtolitres (fL) | Standard Deviation 1.55 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 8 | 0.05 femtolitres (fL) | Standard Deviation 2.11 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 2 | -0.14 femtolitres (fL) | Standard Deviation 1.65 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | SFU | 2.58 femtolitres (fL) | Standard Deviation 5.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 4 | -0.11 femtolitres (fL) | Standard Deviation 1.6 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 12 | 0.76 femtolitres (fL) | Standard Deviation 3.81 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 6 | 0.20 femtolitres (fL) | Standard Deviation 2.84 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 2 | -0.16 femtolitres (fL) | Standard Deviation 1.31 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 6 | 0.14 femtolitres (fL) | Standard Deviation 2.47 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 4 | 0.23 femtolitres (fL) | Standard Deviation 1.89 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 8 | 0.71 femtolitres (fL) | Standard Deviation 2.88 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 1 | 0.52 femtolitres (fL) | Standard Deviation 2.29 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | SFU | 7.80 femtolitres (fL) | Standard Deviation 14.07 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 12 | 0.87 femtolitres (fL) | Standard Deviation 3.23 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 4 | -0.25 femtolitres (fL) | Standard Deviation 1.81 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 2 | -0.33 femtolitres (fL) | Standard Deviation 1.96 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 1 | -0.25 femtolitres (fL) | Standard Deviation 1.64 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 8 | -0.54 femtolitres (fL) | Standard Deviation 2.57 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 12 | 0.17 femtolitres (fL) | Standard Deviation 2.39 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 6 | -0.29 femtolitres (fL) | Standard Deviation 1.9 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | SFU | 0.90 femtolitres (fL) | Standard Deviation 2.38 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 6 | 0.39 femtolitres (fL) | Standard Deviation 1.79 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 1 | 0.51 femtolitres (fL) | Standard Deviation 2.63 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 2 | 0.31 femtolitres (fL) | Standard Deviation 1.32 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 4 | 0.67 femtolitres (fL) | Standard Deviation 1.76 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 8 | 0.16 femtolitres (fL) | Standard Deviation 2.57 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 12 | 0.78 femtolitres (fL) | Standard Deviation 2.55 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | SFU | 0.85 femtolitres (fL) | Standard Deviation 0.35 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 4 | -0.10 femtolitres (fL) | Standard Deviation 1.64 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 2 | -0.64 femtolitres (fL) | Standard Deviation 1.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | SFU | 2.80 femtolitres (fL) | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 1 | -0.23 femtolitres (fL) | Standard Deviation 2.14 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 12 | 0.47 femtolitres (fL) | Standard Deviation 2.88 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 6 | -0.02 femtolitres (fL) | Standard Deviation 1.92 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 8 | -0.02 femtolitres (fL) | Standard Deviation 2.29 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | SFU | 4.87 femtolitres (fL) | Standard Deviation 8.46 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 8 | 0.36 femtolitres (fL) | Standard Deviation 2.37 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 4 | 0.22 femtolitres (fL) | Standard Deviation 2.87 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 2 | -0.05 femtolitres (fL) | Standard Deviation 1.6 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 12 | 0.51 femtolitres (fL) | Standard Deviation 3.89 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 1 | -0.04 femtolitres (fL) | Standard Deviation 1.37 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Erythrocytes Mean Corpuscular Volume) | Week 6 | 0.25 femtolitres (fL) | Standard Deviation 1.85 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit)
Hematocrit was measured in volume percentage (%) of red blood cells in blood.
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 1 | -0.88 volume % of red blood cells | Standard Deviation 2.49 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 8 | -0.52 volume % of red blood cells | Standard Deviation 2.37 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 2 | -0.86 volume % of red blood cells | Standard Deviation 2.02 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | SFU | 0.20 volume % of red blood cells | Standard Deviation 1.44 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 4 | -0.81 volume % of red blood cells | Standard Deviation 2.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 12 | 0.32 volume % of red blood cells | Standard Deviation 2.87 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 6 | -0.33 volume % of red blood cells | Standard Deviation 2.46 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 2 | 0.00 volume % of red blood cells | Standard Deviation 1.65 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 6 | 0.41 volume % of red blood cells | Standard Deviation 1.88 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 4 | 0.24 volume % of red blood cells | Standard Deviation 2.07 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 8 | 0.55 volume % of red blood cells | Standard Deviation 2.51 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 1 | 0.27 volume % of red blood cells | Standard Deviation 2.07 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | SFU | 1.98 volume % of red blood cells | Standard Deviation 6.92 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 12 | 1.25 volume % of red blood cells | Standard Deviation 2.29 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 4 | -0.26 volume % of red blood cells | Standard Deviation 1.86 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 2 | -0.04 volume % of red blood cells | Standard Deviation 2.15 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 1 | 0.33 volume % of red blood cells | Standard Deviation 2.31 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 8 | 0.18 volume % of red blood cells | Standard Deviation 1.84 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 12 | 0.18 volume % of red blood cells | Standard Deviation 2.57 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 6 | -0.04 volume % of red blood cells | Standard Deviation 2.18 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | SFU | -1.20 volume % of red blood cells | Standard Deviation 1.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 6 | 0.02 volume % of red blood cells | Standard Deviation 1.73 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 1 | -0.58 volume % of red blood cells | Standard Deviation 2.14 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 2 | -0.42 volume % of red blood cells | Standard Deviation 2.61 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 4 | -0.26 volume % of red blood cells | Standard Deviation 1.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 8 | 0.14 volume % of red blood cells | Standard Deviation 2.61 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 12 | 0.30 volume % of red blood cells | Standard Deviation 2.99 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | SFU | -1.50 volume % of red blood cells | Standard Deviation 0.14 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 4 | -0.48 volume % of red blood cells | Standard Deviation 2.57 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 2 | -0.65 volume % of red blood cells | Standard Deviation 2.09 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | SFU | 2.10 volume % of red blood cells | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 1 | -0.36 volume % of red blood cells | Standard Deviation 2.31 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 12 | -0.05 volume % of red blood cells | Standard Deviation 2.75 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 6 | -0.51 volume % of red blood cells | Standard Deviation 2.59 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 8 | -0.22 volume % of red blood cells | Standard Deviation 2.46 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | SFU | 1.00 volume % of red blood cells | Standard Deviation 0.85 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 8 | 0.67 volume % of red blood cells | Standard Deviation 2.03 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 4 | -0.03 volume % of red blood cells | Standard Deviation 2.02 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 2 | -0.02 volume % of red blood cells | Standard Deviation 2.03 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 12 | 0.59 volume % of red blood cells | Standard Deviation 2.02 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 1 | -0.23 volume % of red blood cells | Standard Deviation 1.62 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Hematocrit) | Week 6 | 0.44 volume % of red blood cells | Standard Deviation 1.9 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets)
Platelets was measured in number of platelets per liter (10\^9/L).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 1 | 12.1 10^9 platelets per liter | Standard Deviation 34.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 8 | 6.9 10^9 platelets per liter | Standard Deviation 37.6 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 2 | 6.4 10^9 platelets per liter | Standard Deviation 37.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | SFU | 14.8 10^9 platelets per liter | Standard Deviation 33.3 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 4 | -0.1 10^9 platelets per liter | Standard Deviation 32 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 12 | 2.8 10^9 platelets per liter | Standard Deviation 36.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 6 | 5.6 10^9 platelets per liter | Standard Deviation 47.5 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 2 | -8.6 10^9 platelets per liter | Standard Deviation 26.8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 6 | -5.2 10^9 platelets per liter | Standard Deviation 26.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 4 | -5.8 10^9 platelets per liter | Standard Deviation 28.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 8 | -2.3 10^9 platelets per liter | Standard Deviation 44.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 1 | 3.2 10^9 platelets per liter | Standard Deviation 21 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | SFU | -30.3 10^9 platelets per liter | Standard Deviation 71.6 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 12 | -6.0 10^9 platelets per liter | Standard Deviation 36.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 4 | -8.6 10^9 platelets per liter | Standard Deviation 40.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 2 | -5.6 10^9 platelets per liter | Standard Deviation 36.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 1 | -4.6 10^9 platelets per liter | Standard Deviation 30.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 8 | -6.1 10^9 platelets per liter | Standard Deviation 43.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 12 | -13.2 10^9 platelets per liter | Standard Deviation 40.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 6 | -13.6 10^9 platelets per liter | Standard Deviation 34.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | SFU | 7.8 10^9 platelets per liter | Standard Deviation 20 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 6 | -5.6 10^9 platelets per liter | Standard Deviation 30.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 1 | -14.0 10^9 platelets per liter | Standard Deviation 30.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 2 | -8.9 10^9 platelets per liter | Standard Deviation 27.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 4 | -11.4 10^9 platelets per liter | Standard Deviation 21.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 8 | 6.3 10^9 platelets per liter | Standard Deviation 35.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 12 | -3.6 10^9 platelets per liter | Standard Deviation 37.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | SFU | -33.0 10^9 platelets per liter | Standard Deviation 31.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 4 | -7.0 10^9 platelets per liter | Standard Deviation 28.9 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 2 | 7.8 10^9 platelets per liter | Standard Deviation 31.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | SFU | 39.0 10^9 platelets per liter | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 1 | 3.5 10^9 platelets per liter | Standard Deviation 25.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 12 | -5.4 10^9 platelets per liter | Standard Deviation 36.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 6 | -0.3 10^9 platelets per liter | Standard Deviation 44 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 8 | 0.7 10^9 platelets per liter | Standard Deviation 39.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | SFU | 39.3 10^9 platelets per liter | Standard Deviation 27.4 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 8 | -4.7 10^9 platelets per liter | Standard Deviation 36.4 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 4 | -7.5 10^9 platelets per liter | Standard Deviation 36.8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 2 | -3.9 10^9 platelets per liter | Standard Deviation 41.8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 12 | -5.5 10^9 platelets per liter | Standard Deviation 38.8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 1 | -0.1 10^9 platelets per liter | Standard Deviation 35 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Hematology Parameters (Platelets) | Week 6 | -7.6 10^9 platelets per liter | Standard Deviation 37.3 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH)
Urine pH was measured on a pH scale.
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 1 | 0.00 ph | Standard Deviation 0.79 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 8 | -0.03 ph | Standard Deviation 0.92 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 2 | 0.06 ph | Standard Deviation 0.86 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | SFU | 0.25 ph | Standard Deviation 1.04 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 4 | 0.05 ph | Standard Deviation 0.87 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 12 | -0.14 ph | Standard Deviation 0.79 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 6 | -0.01 ph | Standard Deviation 0.73 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 2 | -0.06 ph | Standard Deviation 0.86 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 6 | -0.03 ph | Standard Deviation 0.68 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 4 | -0.09 ph | Standard Deviation 0.76 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 8 | -0.07 ph | Standard Deviation 0.83 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 1 | -0.10 ph | Standard Deviation 0.79 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | SFU | -0.25 ph | Standard Deviation 0.87 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 12 | -0.01 ph | Standard Deviation 0.85 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 4 | -0.11 ph | Standard Deviation 0.95 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 2 | -0.10 ph | Standard Deviation 0.77 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 1 | -0.13 ph | Standard Deviation 0.88 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 8 | -0.12 ph | Standard Deviation 1.07 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 12 | 0.01 ph | Standard Deviation 0.7 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 6 | -0.17 ph | Standard Deviation 0.69 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | SFU | 0.50 ph | Standard Deviation 1.22 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 6 | -0.18 ph | Standard Deviation 0.86 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 1 | -0.20 ph | Standard Deviation 0.88 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 2 | -0.23 ph | Standard Deviation 0.92 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 4 | -0.26 ph | Standard Deviation 0.89 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 8 | -0.34 ph | Standard Deviation 0.79 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 12 | -0.28 ph | Standard Deviation 0.85 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | SFU | -1.00 ph | Standard Deviation 1.41 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 4 | -0.07 ph | Standard Deviation 0.73 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 2 | -0.18 ph | Standard Deviation 0.76 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | SFU | 0.50 ph | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 1 | -0.08 ph | Standard Deviation 0.82 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 12 | -0.21 ph | Standard Deviation 0.99 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 6 | -0.13 ph | Standard Deviation 0.81 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 8 | -0.30 ph | Standard Deviation 0.91 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | SFU | -0.17 ph | Standard Deviation 0.29 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 8 | 0.08 ph | Standard Deviation 0.75 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 4 | -0.04 ph | Standard Deviation 0.74 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 2 | 0.06 ph | Standard Deviation 0.65 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 12 | -0.01 ph | Standard Deviation 0.85 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 1 | -0.07 ph | Standard Deviation 0.9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Urinalysis Parameters (pH) | Week 6 | 0.05 ph | Standard Deviation 0.86 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure)
Blood pressure was measured in millimeters of mercury (mmHg).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 8 | -0.8 mmHg | Standard Deviation 12.1 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 12 | -2.3 mmHg | Standard Deviation 5.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 12 | -1.3 mmHg | Standard Deviation 10.9 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 8 | -1.1 mmHg | Standard Deviation 8.9 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 6 | 0.3 mmHg | Standard Deviation 7.6 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 4 | -2.3 mmHg | Standard Deviation 10 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 2 | -1.1 mmHg | Standard Deviation 9.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 1 | 1.2 mmHg | Standard Deviation 10.7 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 6 | -1.4 mmHg | Standard Deviation 9.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure SFU | 1.3 mmHg | Standard Deviation 8.5 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 4 | -0.3 mmHg | Standard Deviation 7.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 2 | -1.5 mmHg | Standard Deviation 6.9 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 1 | -0.4 mmHg | Standard Deviation 7.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure SFU | -7.0 mmHg | Standard Deviation 12.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 12 | 2.2 mmHg | Standard Deviation 9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 6 | -1.3 mmHg | Standard Deviation 10.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 8 | -1.3 mmHg | Standard Deviation 13 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure SFU | -10.5 mmHg | Standard Deviation 17 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 1 | 0.9 mmHg | Standard Deviation 10 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 2 | 0.4 mmHg | Standard Deviation 8.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 4 | 0.6 mmHg | Standard Deviation 9.2 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 1 | 2.2 mmHg | Standard Deviation 7.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 2 | 2.1 mmHg | Standard Deviation 9.4 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 4 | 2.1 mmHg | Standard Deviation 7.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 6 | 0.0 mmHg | Standard Deviation 9.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 8 | -0.3 mmHg | Standard Deviation 9.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 12 | 0.5 mmHg | Standard Deviation 6.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure SFU | -9.0 mmHg | Standard Deviation 9.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 4 | -0.3 mmHg | Standard Deviation 7.9 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 1 | -2.1 mmHg | Standard Deviation 7.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 6 | -3.1 mmHg | Standard Deviation 7.9 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 4 | -1.9 mmHg | Standard Deviation 11.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 1 | -3.9 mmHg | Standard Deviation 8.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 12 | -1.7 mmHg | Standard Deviation 6.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 12 | -2.9 mmHg | Standard Deviation 10.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 2 | -2.7 mmHg | Standard Deviation 12.5 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 2 | -1.2 mmHg | Standard Deviation 7.1 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure SFU | -1.3 mmHg | Standard Deviation 10.4 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 8 | -1.2 mmHg | Standard Deviation 7.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure SFU | 0.8 mmHg | Standard Deviation 8.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 6 | -4.3 mmHg | Standard Deviation 10.6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 8 | -3.4 mmHg | Standard Deviation 8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure SFU | 4.5 mmHg | Standard Deviation 7.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure SFU | -4.5 mmHg | Standard Deviation 0.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 1 | 0.6 mmHg | Standard Deviation 6.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 6 | 0.1 mmHg | Standard Deviation 12.8 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 2 | 2.1 mmHg | Standard Deviation 8.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 12 | 3.1 mmHg | Standard Deviation 8.4 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 4 | 0.6 mmHg | Standard Deviation 7.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 1 | 1.7 mmHg | Standard Deviation 9.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 2 | 0.2 mmHg | Standard Deviation 13.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 4 | 0.1 mmHg | Standard Deviation 12.4 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 6 | 1.3 mmHg | Standard Deviation 8.6 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 8 | 2.8 mmHg | Standard Deviation 8.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 8 | 0.1 mmHg | Standard Deviation 12.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 12 | -0.3 mmHg | Standard Deviation 11.8 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 8 | -0.7 mmHg | Standard Deviation 7.7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 2 | 0.0 mmHg | Standard Deviation 7.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure SFU | -2.0 mmHg | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 1 | 0.3 mmHg | Standard Deviation 7.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 8 | 0.5 mmHg | Standard Deviation 12.5 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure SFU | -9.0 mmHg | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 1 | 0.2 mmHg | Standard Deviation 12.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 6 | -0.9 mmHg | Standard Deviation 10.9 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 4 | -0.1 mmHg | Standard Deviation 11.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 6 | 0.1 mmHg | Standard Deviation 7.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 4 | 0.0 mmHg | Standard Deviation 7.7 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 12 | -1.2 mmHg | Standard Deviation 10.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 2 | -0.6 mmHg | Standard Deviation 8.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 12 | -1.1 mmHg | Standard Deviation 6.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 2 | -3.2 mmHg | Standard Deviation 11.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 12 | -2.4 mmHg | Standard Deviation 10.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 4 | 0.3 mmHg | Standard Deviation 8.1 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 4 | -0.5 mmHg | Standard Deviation 10.8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 6 | -2.4 mmHg | Standard Deviation 9.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 6 | -1.6 mmHg | Standard Deviation 7.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure SFU | -2.0 mmHg | Standard Deviation 2.6 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 2 | 0.2 mmHg | Standard Deviation 7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 8 | -1.0 mmHg | Standard Deviation 10.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 1 | 0.1 mmHg | Standard Deviation 6.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure SFU | -4.0 mmHg | Standard Deviation 6.6 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 12 | -1.1 mmHg | Standard Deviation 7.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Systolic Blood Pressure Week 1 | -1.0 mmHg | Standard Deviation 9.9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Blood Pressure) | Diastolic Blood Pressure Week 8 | -0.6 mmHg | Standard Deviation 8.2 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate)
Pulse rate was measured in beats per minute (beats/min).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 6 | 0.9 beats/min | Standard Deviation 9.8 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 4 | 1.0 beats/min | Standard Deviation 10.2 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 2 | 1.2 beats/min | Standard Deviation 8.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | SFU | -2.8 beats/min | Standard Deviation 2.6 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 12 | 0.9 beats/min | Standard Deviation 8.4 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 1 | 1.7 beats/min | Standard Deviation 9.5 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 8 | 1.7 beats/min | Standard Deviation 8.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 12 | -1.9 beats/min | Standard Deviation 6.8 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 4 | -3.1 beats/min | Standard Deviation 9.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 1 | -1.6 beats/min | Standard Deviation 9.1 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 2 | -1.3 beats/min | Standard Deviation 9.9 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 6 | 1.2 beats/min | Standard Deviation 10.7 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 8 | -3.2 beats/min | Standard Deviation 9.3 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | SFU | -2.5 beats/min | Standard Deviation 12 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | SFU | 2.3 beats/min | Standard Deviation 6 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 12 | 1.8 beats/min | Standard Deviation 11 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 2 | 1.1 beats/min | Standard Deviation 7.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 1 | 3.2 beats/min | Standard Deviation 8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 4 | 0.6 beats/min | Standard Deviation 7.8 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 8 | 0.4 beats/min | Standard Deviation 9.2 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 6 | 1.4 beats/min | Standard Deviation 8.3 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 8 | -1.8 beats/min | Standard Deviation 8.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 12 | -3.1 beats/min | Standard Deviation 8.5 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | SFU | 1.5 beats/min | Standard Deviation 4.9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 6 | -2.6 beats/min | Standard Deviation 9.7 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 4 | -3.6 beats/min | Standard Deviation 9 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 2 | -1.0 beats/min | Standard Deviation 10.4 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 1 | -1.8 beats/min | Standard Deviation 8.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 8 | 0.5 beats/min | Standard Deviation 8.2 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 4 | -1.6 beats/min | Standard Deviation 6.5 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 6 | -1.7 beats/min | Standard Deviation 9.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | SFU | -7.0 beats/min | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 1 | 0.1 beats/min | Standard Deviation 6.4 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 12 | -1.7 beats/min | Standard Deviation 9.1 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 2 | -2.2 beats/min | Standard Deviation 7.9 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 12 | 0.0 beats/min | Standard Deviation 7.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 4 | 1.6 beats/min | Standard Deviation 8 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | SFU | 7.3 beats/min | Standard Deviation 3.2 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 1 | -0.4 beats/min | Standard Deviation 7.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 8 | 0.6 beats/min | Standard Deviation 6.7 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 2 | 0.5 beats/min | Standard Deviation 9.5 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Pulse Rate) | Week 6 | 2.6 beats/min | Standard Deviation 8 |
Secondary
Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature)
Temperature was measured in degrees Celsius (°C).
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 8 | 0.01 °C | Standard Deviation 0.24 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 4 | -0.05 °C | Standard Deviation 0.29 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | SFU | 0.08 °C | Standard Deviation 0.22 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 1 | -0.07 °C | Standard Deviation 0.23 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 12 | 0.10 °C | Standard Deviation 0.27 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 2 | 0.00 °C | Standard Deviation 0.26 |
| Placebo (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 6 | -0.03 °C | Standard Deviation 0.29 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | SFU | 0.15 °C | Standard Deviation 0.33 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 6 | -0.02 °C | Standard Deviation 0.25 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 8 | -0.02 °C | Standard Deviation 0.28 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 2 | 0.02 °C | Standard Deviation 0.26 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 12 | 0.00 °C | Standard Deviation 0.27 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 1 | -0.04 °C | Standard Deviation 0.22 |
| Bimekizumab 64 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 4 | 0.03 °C | Standard Deviation 0.24 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | SFU | -0.03 °C | Standard Deviation 0.05 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 1 | 0.02 °C | Standard Deviation 0.3 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 2 | 0.01 °C | Standard Deviation 0.33 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 4 | 0.00 °C | Standard Deviation 0.42 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 6 | -0.01 °C | Standard Deviation 0.22 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 8 | 0.00 °C | Standard Deviation 0.33 |
| Bimekizumab 160 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 12 | 0.06 °C | Standard Deviation 0.36 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 1 | -0.11 °C | Standard Deviation 0.32 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 2 | 0.01 °C | Standard Deviation 0.35 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 4 | -0.04 °C | Standard Deviation 0.24 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 6 | -0.06 °C | Standard Deviation 0.43 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 8 | -0.03 °C | Standard Deviation 0.41 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 12 | -0.04 °C | Standard Deviation 0.28 |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | SFU | 0.10 °C | Standard Deviation 0 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 4 | -0.03 °C | Standard Deviation 0.26 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 2 | -0.04 °C | Standard Deviation 0.36 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 1 | -0.07 °C | Standard Deviation 0.3 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 8 | 0.00 °C | Standard Deviation 0.35 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | SFU | 0.10 °C | — |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 12 | 0.00 °C | Standard Deviation 0.33 |
| Bimekizumab 320 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 6 | -0.03 °C | Standard Deviation 0.38 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 6 | 0.07 °C | Standard Deviation 0.24 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 12 | 0.00 °C | Standard Deviation 0.3 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | SFU | 0.43 °C | Standard Deviation 0.31 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 2 | -0.01 °C | Standard Deviation 0.35 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 8 | 0.02 °C | Standard Deviation 0.31 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 1 | 0.02 °C | Standard Deviation 0.35 |
| Bimekizumab 480 mg Q4W (FAS) | Change From Baseline Until Safety Follow-up Visit in Vital Signs (Temperature) | Week 4 | -0.01 °C | Standard Deviation 0.41 |
Secondary
Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50)
The data were presented as population estimates of EC50. EC50 was estimated based on all available data and cannot be derived for each treatment arm. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Time frame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Population: The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. EC50 was estimated based on all available data and cannot be derived for each treatment arm.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (FAS) | Concentration of Bimekizumab Leading to 50% of Maximum Effect (EC50) | 0.55 µg/mL | Geometric Coefficient of Variation 126 |
Secondary
Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 12 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 12.
Time frame: Week 12
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 28.2 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 27.9 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 60.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 55.8 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Achieving a 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 48.8 percentage of participants |
Comparison: The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.p-value: =0.0001Fisher Exact
Comparison: The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.p-value: =0.0002Fisher Exact
Comparison: The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.p-value: <0.0001Fisher Exact
Comparison: The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.p-value: <0.0001Fisher Exact
Comparison: The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.p-value: <0.0001Fisher Exact
Secondary
Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 12
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 4.8 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 61.5 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 81.4 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 85.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 93.0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Achieving a 75% or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 12 | 83.7 percentage of participants |
p-value: <0.000195% CI: [6.82, 156.38]Regression, Logistic
p-value: <0.000195% CI: [18.54, 481.86]Regression, Logistic
p-value: <0.000195% CI: [22.08, 626.89]Regression, Logistic
p-value: <0.000195% CI: [44.06, 1789.24]Regression, Logistic
p-value: <0.000195% CI: [20.82, 558.57]Regression, Logistic
Secondary
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time frame: Week 8
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 | 41.0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 | 58.1 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 | 67.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 | 86.0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 8 | 69.8 percentage of participants |
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher Exact
p-value: <0.0001Fisher Exact
Secondary
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.~Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Normal | 5.1 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Normal | 94.9 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 High | 7.9 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Normal | 2.6 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Normal | 89.5 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 High | 2.7 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Normal | 10.8 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Normal | 86.5 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Normal | 91.2 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 High | 2.9 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Normal | 5.9 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Normal | 95.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Normal | 2.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 High | 2.5 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 High | 5.1 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Normal | 2.6 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Normal - Week 12 Normal | 92.3 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Albumin) | Baseline Low - Week 12 Normal | 0 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.~Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Normal | 7.7 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 High | 2.6 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 High | 5.1 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Normal | 84.6 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Normal | 15.8 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Normal | 84.2 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Normal | 97.3 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 High | 2.7 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 High | 2.9 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Normal | 88.2 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 High | 5.9 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Normal | 2.9 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 High | 5.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Normal | 90.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Normal | 5.0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline High - Week 12 Normal | 7.7 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Normal - Week 12 Normal | 92.3 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Leukocyte Esterase) | Baseline Low - Week 12 Low | 0 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.~Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 High | 2.6 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Normal | 97.4 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Normal | 97.4 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 High | 2.6 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Normal | 100 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Normal | 100 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 High | 2.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 High | 2.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Normal | 95.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 High | 2.6 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline High - Week 12 Normal | 2.6 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Normal | 94.9 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Nitrite) | Baseline Low - Week 12 High | 0 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.~Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Normal | 10.3 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 High | 12.8 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Normal | 76.9 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 High | 2.6 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 High | 5.3 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Normal | 5.3 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Normal | 86.8 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Normal | 5.4 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 High | 10.8 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Normal | 83.8 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 High | 5.9 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Normal | 79.4 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Normal | 8.8 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 High | 5.9 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Normal | 77.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 High | 2.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Normal | 15.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 High | 5.0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 High | 2.6 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 High | 2.6 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Normal | 5.1 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Normal - Week 12 Normal | 89.7 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Occult Blood) | Baseline Low - Week 12 Normal | 0 percentage of participants |
Secondary
Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose)
Percentages were based on the number of participants with non-missing urinalysis results at Baseline and at Week 12.
Time frame: From Baseline (Week 0) until Week 12
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.~Number of participants reflect those with non-missing urinalysis results at Baseline and at Week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 High | 5.1 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Normal | 94.9 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 High | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Normal | 94.7 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 High | 2.6 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 High | 2.6 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Normal | 97.3 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 High | 2.7 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 High | 2.9 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Normal | 97.1 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 High | 2.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Normal | 2.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Normal | 95.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 High | 5.1 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 High | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline High - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Low | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Low - Week 12 Normal | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants Who Shifted From Baseline Until Week 12 in Urinalysis Parameters (Urine Glucose) | Baseline Normal - Week 12 Normal | 94.9 percentage of participants |
Secondary
Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment
Overall antibody positive was defined as having a value of \> 28.5% at any time in the Treatment Period. The Treatment Period did not include Baseline/pretreatment samples.
Time frame: From Week 4 until the Safety Follow-Up visit (20 weeks after the last dose; Up to Week 28)
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment | 10.3 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment | 4.8 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment | 5.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With an Overall Positive Anti-bimekizumab Antibody (AbAb) Status Following Study Treatment | 0 percentage of participants |
Secondary
Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment
Antibody positive status prior study treatment was defined as having an antibody level greater than (\>) 28.5% at Baseline (Week 0).
Time frame: Baseline (Week 0)
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment | 2.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With a Positive Anti-bimekizumab Antibody (AbAb) Status Prior to Study Treatment | 0 percentage of participants |
Secondary
Percentage of Participants With at Least One Adverse Event (AE) During the Study
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time frame: From Screening to End of Safety Follow-up (up to Week 32)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 38.1 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 76.9 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 55.8 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 65.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 60.5 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study | 60.5 percentage of participants |
Secondary
Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Time frame: From Screening to End of Safety Follow-up (up to Week 32)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Severe | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Mild | 11.9 percentage of participants |
| Placebo (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Moderate | 26.2 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Mild | 43.6 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Moderate | 30.8 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Severe | 2.6 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Severe | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Moderate | 27.9 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Mild | 27.9 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Severe | 2.5 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Moderate | 40.0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Mild | 22.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Moderate | 20.9 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Severe | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Mild | 39.5 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Mild | 44.2 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Severe | 4.7 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With at Least One Adverse Event (AE) During the Study by Severity | Moderate | 11.6 percentage of participants |
Secondary
Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Percentages were based on the number of participants with a non-missing measurement for that variable at the visit.
Time frame: Baseline (Week 0), Week 2, Week 4, Week 6, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 2 | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | SFU | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 12 | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 4 | 0 percentage of participants |
| Placebo (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 6 | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | SFU | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 12 | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 6 | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 4 | 0 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 2 | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 2 | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 6 | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 12 | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | SFU | 0 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 4 | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 6 | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 4 | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 12 | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | SFU | 0 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 2 | 2.6 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline | 2.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | SFU | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 2 | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 6 | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 4 | 0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 12 | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 2 | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 4 | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | SFU | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Baseline | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 6 | 0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings | Week 12 | 0 percentage of participants |
Secondary
Percentage of Participants With Clinically Significant Physical Examination Abnormalities
The physical examination included general appearance; ear, nose, and throat; eyes, hair, and skin; respiratory; CV; GI; musculoskeletal; hepatic; neurological (including limb reflexes); and mental status. Any clinically significant abnormal findings during the study were captured as adverse events.
Time frame: At Screening, Week 12/Early Withdrawal Visit and the Safety Follow-Up Visit (20 weeks after the last dose)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the IMP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants With Clinically Significant Physical Examination Abnormalities | 23.8 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Physical Examination Abnormalities | 7.7 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Physical Examination Abnormalities | 11.6 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With Clinically Significant Physical Examination Abnormalities | 10.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Physical Examination Abnormalities | 9.3 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With Clinically Significant Physical Examination Abnormalities | 0 percentage of participants |
Secondary
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Time frame: Week 12
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 | 4.8 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 | 51.3 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 | 74.4 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 | 75.0 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 | 86.0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 12 | 76.7 percentage of participants |
p-value: =0.000195% CI: [4.51, 101.88]Regression, Logistic
p-value: <0.000195% CI: [12.9, 309.83]Regression, Logistic
p-value: <0.000195% CI: [12.61, 308.29]Regression, Logistic
p-value: <0.000195% CI: [24.5, 693.51]Regression, Logistic
p-value: <0.000195% CI: [14.07, 342.4]Regression, Logistic
Secondary
Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8
The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.
Time frame: Week 8
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and had a valid measurement of the primary efficacy variable at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 | 4.8 percentage of participants |
| Bimekizumab 64 mg Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 | 46.2 percentage of participants |
| Bimekizumab 160 mg Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 | 62.8 percentage of participants |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 | 77.5 percentage of participants |
| Bimekizumab 320 mg Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 | 86.0 percentage of participants |
| Bimekizumab 480 mg Q4W (FAS) | Percentage of Participants With Investigator's Global Assessment (IGA) (Clear or Almost Clear With at Least 2 Category Improvement From Baseline) Response at Week 8 | 72.1 percentage of participants |
p-value: =0.000395% CI: [3.79, 87.76]Regression, Logistic
p-value: <0.000195% CI: [8.19, 191.59]Regression, Logistic
p-value: <0.000195% CI: [15.19, 392.93]Regression, Logistic
p-value: <0.000195% CI: [26.26, 767.72]Regression, Logistic
p-value: <0.000195% CI: [11.89, 288]Regression, Logistic
Secondary
Plasma Concentrations of Bimekizumab During the Study
Bimekizumab plasma concentration was expressed in micrograms per milliliter (μg/mL). Values Below Limit of Quantification (BLQ) were replaced by the value of lower limit of quantification (LLOQ) divided by 2 = 0.075 μg/mL in the calculations of geometric mean and confidence intervals (CIs). Geometric mean was only calculated if at least two-thirds of the concentrations were quantified at the respective time point.
Time frame: Baseline (Week 0), Week 1, Week 2, Week 4, Week 8, Week 12, and Safety Follow-Up visit (20 weeks after the last dose)
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo (FAS) | Plasma Concentrations of Bimekizumab During the Study | Baseline | NA µg/mL |
| Placebo (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 4 | 2.1282 µg/mL |
| Placebo (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 12 | 2.3121 µg/mL |
| Placebo (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 2 | 3.4704 µg/mL |
| Placebo (FAS) | Plasma Concentrations of Bimekizumab During the Study | SFU | NA µg/mL |
| Placebo (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 1 | 4.4490 µg/mL |
| Placebo (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 8 | 2.3069 µg/mL |
| Bimekizumab 64 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 8 | 7.1859 µg/mL |
| Bimekizumab 64 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 4 | 5.3751 µg/mL |
| Bimekizumab 64 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | SFU | NA µg/mL |
| Bimekizumab 64 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 1 | 9.2481 µg/mL |
| Bimekizumab 64 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 12 | 9.5278 µg/mL |
| Bimekizumab 64 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 2 | 8.6862 µg/mL |
| Bimekizumab 64 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Baseline | NA µg/mL |
| Bimekizumab 160 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 4 | 11.2903 µg/mL |
| Bimekizumab 160 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Baseline | NA µg/mL |
| Bimekizumab 160 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 1 | 20.7892 µg/mL |
| Bimekizumab 160 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 2 | 19.0428 µg/mL |
| Bimekizumab 160 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 8 | 10.2208 µg/mL |
| Bimekizumab 160 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 12 | 10.2557 µg/mL |
| Bimekizumab 160 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | SFU | NA µg/mL |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 2 | 19.0324 µg/mL |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 8 | 16.3187 µg/mL |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 1 | 21.8622 µg/mL |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | SFU | NA µg/mL |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 12 | 18.3166 µg/mL |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Baseline | NA µg/mL |
| Bimekizumab 160 mg w/ LD Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 4 | 11.9194 µg/mL |
| Bimekizumab 320 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 2 | 27.5641 µg/mL |
| Bimekizumab 320 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | SFU | 0.5165 µg/mL |
| Bimekizumab 320 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 12 | 28.0908 µg/mL |
| Bimekizumab 320 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 8 | 23.3285 µg/mL |
| Bimekizumab 320 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 1 | 31.8019 µg/mL |
| Bimekizumab 320 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Baseline | NA µg/mL |
| Bimekizumab 320 mg Q4W (FAS) | Plasma Concentrations of Bimekizumab During the Study | Week 4 | 17.1811 µg/mL |
Secondary
Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab
The data were presented as population estimates of CL/F. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Time frame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Population: The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Given the sparse nature of PK sampling, CL/F cannot be estimated for each treatment group.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (FAS) | Population PK (Apparent Total Clearance (CL/F)) of Bimekizumab | 0.362 L/Day | Geometric Coefficient of Variation 41.7 |
Secondary
Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab
The data were presented as population estimates of V/F. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group. It was prespecified in the data analysis plan to combine doses to perform Population PK and PK/PD analysis based on a prior determination that the PK parameters are not dose-dependent.
Time frame: From Baseline (Week 0) until Safety Follow-Up Visit (20 weeks after the last dose; Up to Week 28)
Population: The PK-PPS consisted of all randomized participants who took at least 1 dose of the IMP and provided at least 1 quantifiable plasma concentration postdose and had no important protocol deviations affecting the PK variables. Given the sparse nature of PK sampling, V/F cannot be estimated for each treatment group.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (FAS) | Population PK (Apparent Volume of Distribution (V/F)) of Bimekizumab | 11.5 liters | Geometric Coefficient of Variation 146 |