Moderate to Severe Plaque Psoriasis
Conditions
Keywords
bimekizumab, BKZ, adolescent study participants, psoriasis, PSO
Brief summary
The purpose of the study is to assess th pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO).
Interventions
DRUGbimekizumab
Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be ≥12 to less than 18 years of age at the time of signing the informed consent/assent according to local regulation * Participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit and: 1. Body surface area (BSA) affected by PSO ≥10% 2. Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4) 3. Psoriasis Area and Severity Index (PASI) score ≥12 OR 4. PASI score ≥10 plus at least 1 of the following: i. Clinically relevant facial involvement ii. Clinically relevant genital involvement iii. Clinically relevant hand and foot involvement * Participant must be candidate for systemic PSO therapy and/or photo/chemotherapy * Body weight ≥30 kg and body mass index for age percentile of ≥5 at Baseline * Male or female A female participant will be eligible to participate if she is not pregnant, not breastfeeding, and a woman of childbearing potential (WOCBP) agrees to follow the contraceptive guidance * Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate)
Exclusion criteria
* Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO * Participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD * History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated * Participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) * Participant has laboratory abnormalities at Screening * Participant has experienced primary failure to one or more interleukin-17 (IL-17) biologic response modifier OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier * Presence of active suicidal ideation, or positive suicide behavior * Participant has been diagnosed with severe depression in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of Bimekizumab at Week 0 | Baseline (Week 0) | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 0. PK-PPS = Pharmacokinetic per-protocol set, IMP = investigational medicinal product. |
| Plasma Concentration of Bimekizumab at Week 1 | Week 1 | Blood samples were collected to determine the bimekizumab plasma concentration at Week 1. |
| Plasma Concentration of Bimekizumab at Week 4 | Week 4 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 4. |
| Plasma Concentration of Bimekizumab at Week 8 | Week 8 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 8. |
| Plasma Concentration of Bimekizumab at Week 12 | Week 12 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 12. |
| Plasma Concentration of Bimekizumab at Week 16 | Week 16 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 16. |
| Plasma Concentration of Bimekizumab at Week 20 | Week 20 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 20. |
| Plasma Concentration of Bimekizumab at Week 40 | Week 40 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 40. |
| Plasma Concentration of Bimekizumab at Week 64 | Week 64 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 64. |
| Plasma Concentration of Bimekizumab at Week 88 | Week 88 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 88. |
| Plasma Concentration of Bimekizumab at Week 112 | Week 112 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 112. |
| Plasma Concentration of Bimekizumab at Week 124 | Week 124 | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 124. |
| Plasma Concentration of Bimekizumab at Safety Follow up (SFU) | Week 140 (SFU) | Blood samples were collected prior to the scheduled dose to determine the bimekizumab plasma concentration at Week 140 (SFU). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)] | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. The last dose was given 4 weeks prior end of extension period. |
| Percentage of Participants With Serious Treatment-emergent Adverse Events | From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140) | An serious adverse event (SAE) must meet 1 or more of the following criteria: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. The data was rounded to one decimal place. The last dose was given 4 weeks prior end of extension period. |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation of Investigational Medicinal Product (IMP) | From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. The last dose was given 4 weeks prior end of extension period. |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From the Study | From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. Treatment-emergent AEs are defined as those AEs that started date on or following the first dose of IMP through the final dose of IMP +20 weeks. This measure considers any TEAEs leading to withdrawal from the study. The last dose was given 4 weeks prior end of extension period. |
| Exposure-adjusted Incidence Rates (EAIR) of Selected Safety Topics of Interest | From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140) | Selected safety topics of interest (including infection \[serious, opportunistic, fungal, and tuberculosis (TB)\], inflammatory bowel disease \[IBD\], and injection site reactions) with onset occurring from day of first dose through 20 weeks after final dose of IMP adjusted by duration of participant exposure to IMP. The exposure-adjusted incidence rate (EAIR) is defined as the number of participants (n) with a specific AE adjusted for the exposure and was scaled to 100 participant-years. The last dose was given 4 weeks prior end of extension period. |
| Change From Baseline in Vital Signs (Systolic and Diastolic Blood Pressure) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Blood pressure was measured in millimeters of mercury (mmHg). |
| Change From Baseline in Vital Signs (Pulse Rate) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Pulse rate was measured in beats per minute (beats/min). |
| Change From Baseline in Vital Signs (Temperature) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Temperature (oral, axillary, otic or non-contact forehead) was measured in degrees Celsius (°C). |
| Change From Baseline in Hematology Parameters (Platelet Count) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Platelets was measured in number of platelets per liter (10\^9/L). |
| Change From Baseline in Hematology Parameters (Mean Corpuscular Hemoglobin) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Mean corpuscular hemoglobin (HGB) was measured in picograms (pg). |
| Change From Baseline in Hematology Parameters (Mean Corpuscular Volume) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Mean corpuscular volume was measured in femtolitres. |
| Change From Baseline in Hematology Parameters (Erythrocytes) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Erythrocytes was measured in number of red blood cells per liter (10\^12/L). |
| Change From Baseline in Hematology Parameters (Hemoglobin) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Hemoglobin was measured in grams per liter. |
| Change From Baseline in Hematology Parameters (Hematocrit) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Hematocrit was measured in volume percentage (%) of red blood cells in the blood. |
| Change From Baseline in Clinical Chemistry Parameters (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase was measured in units per liter. |
| Change From Baseline in Hematology Parameters (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes was measured in number of white blood cells per liter (10\^9/L). |
| Change From Baseline in Clinical Chemistry Parameters (Calcium, Potassium, Sodium, Blood Urea Nitrogen, Glucose (Nonfasting) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Calcium, potassium, sodium, blood urea nitrogen, and glucose (non fasting) was measured in millimoles per liter (mmol/L). |
| Change From Baseline in Clinical Chemistry Parameters (Creatinine, Total and Direct Bilirubin) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Creatinine and bilirubin was measured in micromols per liter (μmol/L). |
| Change From Baseline in Clinical Chemistry Parameters (Total Protein) | Baseline (Week 0), Weeks 16, 124, Safety Follow-Up (up to Week 140) | Total protein was measured in gram per liter (g/L) |
| Change From Baseline in Height | Baseline (Week 0), Weeks 16, 124 | Growth assessment, as assessed by the change from Baseline in height. |
| Change From Baseline in Weight | Baseline (Week 0), Weeks 16, 124 | Growth assessment, as assessed by the change from Baseline in weight. |
| Percentage of Participants With Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Week 16 | Percentage of participants with PASI 90 response at Week 16 is reported. PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. This is scoring system that averages redness, thickness, and scaliness of psoriatic lesions(on a 0-4 scale), and weights resulting score by area of skin involved. Body divided into 4 areas:head, arms, trunk to groin, and legs to top of buttocks. Assignment of average score for redness, thickness, and scaling for each of 4 body areas with score of 0(none) to 4(very marked). Determining percentage of skin covered with psoriasis(PSO) for each of body areas and converting to 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved PSO area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum possible PASI score is 0=no disease, maximum score is 72=maximal disease. Data was rounded to one decimal place. |
| Percentage of Participants With Investigator's Global Assessment (IGA) 0/1 (Clear [0]/Almost Clear [1] With at Least 2-category Improvement From Baseline) Response at Week 16 | 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. IGA response (Clear or Almost Clear) is defined as clear \[0\] or almost clear \[1\] with at least a two-category improvement from Baseline. The data was rounded to one decimal place. |
| Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 | Week 4 | Percentage of participants with PASI75 response at Week 4 is reported. PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. This is scoring system that averages redness, thickness, and scaliness of psoriatic lesions (on a 0-4 scale), and weights resulting score by 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 redness, thickness, and scaling for each of 4 body areas with a score of 0 (clear) to 4 (very marked). Determining percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of psoriatic skin lesions, multiplied by involved psoriasis area score of respective section, and weighted by percentage of person's affected skin for respective section. Minimum possible PASI score is 0=no disease, maximum score is 72=maximal disease. Data was rounded to one decimal place. |
| Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Prior to Investigational Medicinal Product (IMP) Administration | Baseline (Week 0) | Anti-bimekizumab antibody (AbAb) detection prior to IMP administration. Anti-bimekizumab antibodies was measured using 3-tiered assay approach: screening assay, confirmatory assay, and titration assay. Antidrug antibody (ADAb) positive status: any sample that is positive screen and positive immunodepletion (regardless of availability of a titer value). ADAb negative status: any sample that is either negative screen, or positive screen and negative immunodepletion, and where the bimekizumab concentration is less than or equal to the drug tolerance limit of the validated ADAb assay. ADAb missing status: any sample that is either negative screen or positive screen and negative immunodepletion and where the bimekizumab concentration exceeds the validated ADAb assay drug tolerance limit. |
| Percentage of Participants With Anti-bimekizumab Antibody (AbAb) Detection Following Investigational Medicinal Product (IMP) Administration | From Baseline (Week 0, post-first dose) to Safety Follow-Up (Week 140) | Anti-bimekizumab antibody (AbAb) detection following IMP administration. Overall ADAb positive is defined as having at least one sample that is confirmed positive following the 1st dose of IMP to SFU (regardless of missing data). Overall ADAb negative is defined as having all samples reported as negative, or has only one missing/inconclusive sample, following the 1st dose of IMP to SFU. Overall ADAb missing if the study participant has more than one missing ADAb sample for any reason and all other available ADAb samples are negative. The data was rounded to one decimal place. |
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Response at Week 16 | Baseline, Week 16 | The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week, (ie, over the last 7 days). The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol). |
Countries
Canada, Germany, Poland, United States
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273
Participant flow
Recruitment details
The study started to enroll participants in April 2021 and concluded in March 2025.
Pre-assignment details
The Participant Flow refers to the Randomized Set (RS).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 14.8 years STANDARD_DEVIATION 1.9 |
| Age, Customized 12 - <18 years | 41 Participants |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 40 Participants |
| Race/Ethnicity, Customized White | 40 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 17 / 20 | 17 / 21 |
| serious Total, serious adverse events | 2 / 20 | 3 / 21 |
Outcome results
None listed