Chronic Plaque Psoriasis
Conditions
Keywords
Psoriasis, Chronic Plaque Psoriasis, Bimekizumab
Brief summary
This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
Interventions
DRUGBimekizumab
Based on their randomization subjects will receive a combination of several injections of Bimekizumab.
OTHERPlacebo
Subjects will receive injections of Placebo.
Sponsors
UCB Biopharma SRL
Parexel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is an Investigator- and Subject-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female at least 18 years of age and less than or equal to 70 * Chronic plaque psoriasis for at least 6 months prior to Screening * Psoriasis Area and Severity Index (PASI) \>=12 and body surface area (BSA) \>=10% and Investigator's Global Assessment (IGA) score \>=3 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, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose * 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 (anticipated 5 half-lives)
Exclusion criteria
* Subjects previously participating in a bimekizumab study * Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis * History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster) * High risk of infection in the Investigator's opinion * Current sign or symptom that may indicate an active infection * Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection * Live (includes attenuated) vaccination within the 8 weeks prior to Baseline * Subjects with concurrent malignancy or history of malignancy during the past 5 years (except for specific malignant condition as defined in the protocol) * Primary immunosuppressive conditions * TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection * Laboratory abnormalities, as defined in the study protocol * Any condition which, in the Investigator's judgement, would make the subject unsuitable for inclusion in the study * Exposure to more than 1 biological response modifier (limited to anti-TNF or IL-12/-23) or any biologic response modifier during the three months prior to the Baseline Visit * Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of psoriasis or psoriatic arthritis * Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline * Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 | From Baseline to Week 28 | The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity. |
| Plasma Concentration of Bimekizumab at Baseline | at Baseline | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Plasma Concentration of Bimekizumab at Week 2 | at Week 2 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Plasma Concentration of Bimekizumab at Week 4 | at Week 4 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Plasma Concentration of Bimekizumab at Week 8 | at Week 8 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Plasma Concentration of Bimekizumab at Week 12 | at Week 12 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Plasma Concentration of Bimekizumab at Week 16 | at Week 16 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Plasma Concentration of Bimekizumab at Week 20 | at Week 20 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Plasma Concentration of Bimekizumab at Week 24 | at Week 24 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Plasma Concentration of Bimekizumab at Week 28 | at Week 28 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Plasma Concentration of Bimekizumab at Week 36 | at Week 36 | Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means. |
| Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline | at Baseline | An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive. |
| Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab | From Baseline to Safety Follow-Up Visit (Week 36) | An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive. |
| Percentage of Participants Who Experienced at Least One Adverse Events (AEs) | From Screening to Safety Follow-Up Visit (Week 36) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | From Baseline to Week 16 | 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 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | From Baseline to Week 16 | 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 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | From Baseline to Week 16 | The PASI100 response assessments are based on at least 100% 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 With IGA (Investigator´s Global Assessment) Response at Week 16 | at Week 16 | 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. |
Countries
Australia, Canada, Moldova, United States
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273(UCB)
Participant flow
Recruitment details
The study started to enroll patients in December 2016 and concluded in December 2017.
Pre-assignment details
Participant Flow refers to the Safety Set (SS).
Participants by arm
| Arm | Count |
|---|---|
| Bimekizumab 320 mg + PBO Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. | 32 |
| Bimekizumab 320 mg Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. | 17 |
| Total Title | 49 |
| Total | 98 |
Baseline characteristics
| Characteristic | Bimekizumab 320 mg + PBO | Total Title | Bimekizumab 320 mg |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 46 Participants | 16 Participants |
| Age, Continuous | 41.8 years STANDARD_DEVIATION 14.1 | 43.2 years STANDARD_DEVIATION 13 | 45.9 years STANDARD_DEVIATION 10.4 |
| Race/Ethnicity, Customized Asian | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 30 Participants | 42 Participants | 12 Participants |
| Sex: Female, Male Female | 17 Participants | 23 Participants | 6 Participants |
| Sex: Female, Male Male | 15 Participants | 26 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 17 |
| other Total, other adverse events | 28 / 32 | 15 / 17 |
| serious Total, serious adverse events | 2 / 32 | 1 / 17 |
Outcome results
Primary
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28
The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.
Time frame: From Baseline to Week 28
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 | -10.76 scores on a scale | Standard Deviation 7.58 |
| Bimekizumab 320 mg (FAS) | Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 | -19.74 scores on a scale | Standard Deviation 8.77 |
Primary
Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab
An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.
Time frame: From Baseline to Safety Follow-Up Visit (Week 36)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab | 34.4 percentage of participants |
| Bimekizumab 320 mg (FAS) | Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab | 47.1 percentage of participants |
Primary
Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline
An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.
Time frame: at Baseline
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication. Percentages were based on the number of participants with a non-missing measurement at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline | 3.1 percentage of participants |
| Bimekizumab 320 mg (FAS) | Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline | 0 percentage of participants |
Primary
Percentage of Participants Who Experienced at Least One Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs).
Time frame: From Screening to Safety Follow-Up Visit (Week 36)
Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Percentage of Participants Who Experienced at Least One Adverse Events (AEs) | 87.5 percentage of participants |
| Bimekizumab 320 mg (FAS) | Percentage of Participants Who Experienced at Least One Adverse Events (AEs) | 88.2 percentage of participants |
Primary
Plasma Concentration of Bimekizumab at Baseline
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Baseline
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Baseline.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Baseline | NA μg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Baseline | NA μg/mL |
Primary
Plasma Concentration of Bimekizumab at Week 12
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Week 12
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 12.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Week 12 | 5.972 μg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Week 12 | 5.466 μg/mL |
Primary
Plasma Concentration of Bimekizumab at Week 16
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Week 16
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 16.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Week 16 | 2.200 µg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Week 16 | 2.293 µg/mL |
Primary
Plasma Concentration of Bimekizumab at Week 2
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Week 2
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Week 2 | 19.749 μg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Week 2 | 14.437 μg/mL |
Primary
Plasma Concentration of Bimekizumab at Week 20
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Week 20
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 20.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Week 20 | 0.798 μg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Week 20 | 9.702 μg/mL |
Primary
Plasma Concentration of Bimekizumab at Week 24
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Week 24
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 24.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Week 24 | NA μg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Week 24 | 4.377 μg/mL |
Primary
Plasma Concentration of Bimekizumab at Week 28
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Week 28
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 28.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Week 28 | NA μg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Week 28 | 1.933 μg/mL |
Primary
Plasma Concentration of Bimekizumab at Week 36
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Week 36
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 36.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Week 36 | NA μg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Week 36 | 0.322 μg/mL |
Primary
Plasma Concentration of Bimekizumab at Week 4
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Week 4
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 4.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Week 4 | 11.402 μg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Week 4 | 9.077 μg/mL |
Primary
Plasma Concentration of Bimekizumab at Week 8
Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.
Time frame: at Week 8
Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Week 8.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Plasma Concentration of Bimekizumab at Week 8 | 16.728 μg/mL |
| Bimekizumab 320 mg (FAS) | Plasma Concentration of Bimekizumab at Week 8 | 13.969 μg/mL |
Secondary
Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
The PASI100 response assessments are based on at least 100% 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: From Baseline to Week 16
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | 46.9 percentage of participants |
| Bimekizumab 320 mg (FAS) | Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | 52.9 percentage of participants |
Secondary
Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
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: From Baseline to Week 16
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | 93.8 percentage of participants |
| Bimekizumab 320 mg (FAS) | Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | 88.2 percentage of participants |
Secondary
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
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: From Baseline to Week 16
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | 84.4 percentage of participants |
| Bimekizumab 320 mg (FAS) | Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 | 70.6 percentage of participants |
Secondary
Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16
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: at Week 16
Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bimekizumab 320 mg + PBO (FAS) | Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16 | 81.3 percentage of participants |
| Bimekizumab 320 mg (FAS) | Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16 | 64.7 percentage of participants |