Back to resultsA Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis (BE CONNECTED)
Primary Purpose
Moderate to Severe Plaque Psoriasis
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bimekizumab
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Plaque Psoriasis focused on measuring bimekizumab, BKZ, adolescent study participants, psoriasis, PSO
Eligibility Criteria
Inclusion Criteria:
- Participant must be ≥12 to <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:
- Body surface area (BSA) affected by PSO ≥10%
- Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
- Psoriasis Area and Severity Index (PASI) score ≥12 OR
- 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
Sites / Locations
- Ps0020 50344
- Ps0020 50359
- Ps0020 50354
- Ps0020 50357
- Ps0020 40645
- Ps0020 40626
- Ps0020 40625
- Ps0020 40396
- Ps0020 40335
- Ps0020 40333
- Ps0020 40334
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bimekizumab Dose A
Bimekizumab Dose B
Arm Description
Study participants randomized to this arm will receive bimekizumab (BKZ) Dose A at pre-specified time points during the study.
Study participants randomized to this arm will receive bimekizumab (BKZ) Dose B at pre-specified time points during the study.
Outcomes
Primary Outcome Measures
Plasma concentration of bimekizumab at Week 0
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 0.
Plasma concentration of bimekizumab at Week 1
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 1.
Plasma concentration of bimekizumab at Week 4
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 4.
Plasma concentration of bimekizumab at Week 8
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 8.
Plasma concentration of bimekizumab at Week 12
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 12.
Plasma concentration of bimekizumab at Week 16
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 16.
Plasma concentration of bimekizumab at Week 20
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 20.
Plasma concentration of bimekizumab at Week 36
Blood samples will be collected at pre-specified time points at Week 36 to determine the bimekizumab plasma concentration, if participant is not eligible for the Open-label Extension (OLE) Period at Week 20 or does not wish to continue into the OLE Period.
Plasma concentration of bimekizumab at Week 40
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 40.
Plasma concentration of bimekizumab at Week 64
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 64.
Plasma concentration of bimekizumab at Week 88
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 88.
Plasma concentration of bimekizumab at Week 112
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 112.
Plasma concentration of bimekizumab at Week 124
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 124.
Plasma concentration of bimekizumab at safety follow up (SFU)
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 140 (SFU).
Secondary Outcome Measures
Percentage of participants with treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks.
Percentage of participants with serious TEAEs
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 have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks.
Percentage of participants with TEAEs leading to discontinuation of investigational medicinal product (IMP)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start 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.
Percentage of participants with selected safety topics of interest
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.
Change from Baseline in vital signs (systolic and diastolic blood pressure)
Blood pressure will be measured in millimeters of mercury (mmHg).
Change from Baseline in vital signs (heart rate or pulse rate)
Heart rate will be measured in beats per minute (beats/min).
Change from Baseline in vital signs (temperature)
Temperature (oral, axillary, otic or non-contact forehead) will be measured in degrees Celsius (°C).
Change from Baseline in physical examination findings reported as TEAEs with onset occurring from day of first dose through 20 weeks after final dose of IMP
Clinically significant findings or worsening of previous findings since the physical examination at Baseline will be reported as TEAEs with onset occurring from day of first dose through 20 weeks after final dose of IMP.
Change from Baseline in hematology parameters (platelet count)
Platelets will be measured in number of platelets per liter (10^9/L).
Change from Baseline in hematology parameters (mean corpuscular hemoglobin)
Mean corpuscular hemoglobin (HGB) will be measured in picograms (pg).
Change from Baseline in hematology parameters (mean corpuscular volume)
Mean corpuscular volume will be measured in femtolitres (fL).
Change from Baseline in hematology parameters (erythrocytes)
Erythrocytes will be measured in number of red blood cells per liter (10^12/L).
Change from Baseline in hematology parameters (hemoglobin)
Hemoglobin will be measured in grams per liter (g/L).
Change from Baseline in hematology parameters (hematocrit)
Hematocrit will be measured in volume percentage (%) of red blood cells in blood.
Change from Baseline in clinical chemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase)
Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase will be measured in units per liter (U/L).
Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)
Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes will be 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))
Calcium, potassium, sodium, blood urea nitrogen, and glucose (non fasting) will be measured in millimoles per liter (mmol/L).
Change from Baseline in clinical chemistry parameters (creatinine, total and direct bilirubin)
Creatinine and bilirubin will be measured in micromols per liter (μmol/L).
Change from Baseline in clinical chemistry parameters (total protein)
Total protein will be measured in milligrams per liters (mg/L).
Change from Baseline in height
Growth assessment, as assessed by the change from Baseline in height.
Change from Baseline in weight
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
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 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
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.
Percentage of participants with Psoriasis Area and Severity Index (PASI) 75 response at Week 4
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 with anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration
Anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration
Percentage of participants with anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration
Anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration
Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) response at 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04718896
Brief Title
A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
Acronym
BE CONNECTED
Official Title
A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
April 3, 2025 (Anticipated)
Study Completion Date
April 3, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Plaque Psoriasis
Keywords
bimekizumab, BKZ, adolescent study participants, psoriasis, PSO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekizumab Dose A
Arm Type
Experimental
Arm Description
Study participants randomized to this arm will receive bimekizumab (BKZ) Dose A at pre-specified time points during the study.
Arm Title
Bimekizumab Dose B
Arm Type
Experimental
Arm Description
Study participants randomized to this arm will receive bimekizumab (BKZ) Dose B at pre-specified time points during the study.
Intervention Type
Drug
Intervention Name(s)
bimekizumab
Other Intervention Name(s)
BKZ, UCB4940
Intervention Description
Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.
Primary Outcome Measure Information:
Title
Plasma concentration of bimekizumab at Week 0
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 0.
Time Frame
Baseline (Week 0)
Title
Plasma concentration of bimekizumab at Week 1
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 1.
Time Frame
Week 1
Title
Plasma concentration of bimekizumab at Week 4
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 4.
Time Frame
Week 4
Title
Plasma concentration of bimekizumab at Week 8
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 8.
Time Frame
Week 8
Title
Plasma concentration of bimekizumab at Week 12
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 12.
Time Frame
Week 12
Title
Plasma concentration of bimekizumab at Week 16
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 16.
Time Frame
Week 16
Title
Plasma concentration of bimekizumab at Week 20
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 20.
Time Frame
Week 20
Title
Plasma concentration of bimekizumab at Week 36
Description
Blood samples will be collected at pre-specified time points at Week 36 to determine the bimekizumab plasma concentration, if participant is not eligible for the Open-label Extension (OLE) Period at Week 20 or does not wish to continue into the OLE Period.
Time Frame
Week 36
Title
Plasma concentration of bimekizumab at Week 40
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 40.
Time Frame
Week 40
Title
Plasma concentration of bimekizumab at Week 64
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 64.
Time Frame
Week 64
Title
Plasma concentration of bimekizumab at Week 88
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 88.
Time Frame
Week 88
Title
Plasma concentration of bimekizumab at Week 112
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 112.
Time Frame
Week 112
Title
Plasma concentration of bimekizumab at Week 124
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 124.
Time Frame
Week 124
Title
Plasma concentration of bimekizumab at safety follow up (SFU)
Description
Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 140 (SFU).
Time Frame
Week 140 (SFU)
Secondary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent adverse events (TEAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks.
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)]
Title
Percentage of participants with serious TEAEs
Description
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 have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks.
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Percentage of participants with TEAEs leading to discontinuation of investigational medicinal product (IMP)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start 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.
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Percentage of participants with selected safety topics of interest
Description
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.
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in vital signs (systolic and diastolic blood pressure)
Description
Blood pressure will be measured in millimeters of mercury (mmHg).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in vital signs (heart rate or pulse rate)
Description
Heart rate will be measured in beats per minute (beats/min).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in vital signs (temperature)
Description
Temperature (oral, axillary, otic or non-contact forehead) will be measured in degrees Celsius (°C).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in physical examination findings reported as TEAEs with onset occurring from day of first dose through 20 weeks after final dose of IMP
Description
Clinically significant findings or worsening of previous findings since the physical examination at Baseline will be reported as TEAEs with onset occurring from day of first dose through 20 weeks after final dose of IMP.
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in hematology parameters (platelet count)
Description
Platelets will be measured in number of platelets per liter (10^9/L).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in hematology parameters (mean corpuscular hemoglobin)
Description
Mean corpuscular hemoglobin (HGB) will be measured in picograms (pg).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in hematology parameters (mean corpuscular volume)
Description
Mean corpuscular volume will be measured in femtolitres (fL).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in hematology parameters (erythrocytes)
Description
Erythrocytes will be measured in number of red blood cells per liter (10^12/L).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in hematology parameters (hemoglobin)
Description
Hemoglobin will be measured in grams per liter (g/L).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in hematology parameters (hematocrit)
Description
Hematocrit will be measured in volume percentage (%) of red blood cells in blood.
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in clinical chemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase)
Description
Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase will be measured in units per liter (U/L).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)
Description
Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes will be measured in number of white blood cells per liter (10^9/L)
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in clinical chemistry parameters (calcium, potassium, sodium, blood urea nitrogen, glucose (nonfasting))
Description
Calcium, potassium, sodium, blood urea nitrogen, and glucose (non fasting) will be measured in millimoles per liter (mmol/L).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in clinical chemistry parameters (creatinine, total and direct bilirubin)
Description
Creatinine and bilirubin will be measured in micromols per liter (μmol/L).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in clinical chemistry parameters (total protein)
Description
Total protein will be measured in milligrams per liters (mg/L).
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in height
Description
Growth assessment, as assessed by the change from Baseline in height.
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in weight
Description
Growth assessment, as assessed by the change from Baseline in weight.
Time Frame
From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
Title
Percentage of participants with Psoriasis Area and Severity Index (PASI) 90 response at Week 16
Description
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 16
Title
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
Description
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.
Time Frame
Week 16
Title
Percentage of participants with Psoriasis Area and Severity Index (PASI) 75 response at Week 4
Description
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 4
Title
Percentage of participants with anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration
Description
Anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration
Time Frame
Baseline (Week 0)
Title
Percentage of participants with anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration
Description
Anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration
Time Frame
From Week 1 through 20 weeks after final dose of IMP (up to Week 140)
Title
Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) response at Week 16
Description
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).
Time Frame
Week 16, compared to Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Body surface area (BSA) affected by PSO ≥10%
Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
Psoriasis Area and Severity Index (PASI) score ≥12 OR
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
Ps0020 50344
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Ps0020 50359
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
Ps0020 50354
City
Calgary
Country
Canada
Facility Name
Ps0020 50357
City
St. John's
Country
Canada
Facility Name
Ps0020 40645
City
Frankfurt
Country
Germany
Facility Name
Ps0020 40626
City
Bialystok
Country
Poland
Facility Name
Ps0020 40625
City
Lodz
Country
Poland
Facility Name
Ps0020 40396
City
Rzeszow
Country
Poland
Facility Name
Ps0020 40335
City
Warszawa
Country
Poland
Facility Name
Ps0020 40333
City
Wroclaw
Country
Poland
Facility Name
Ps0020 40334
City
Wroclaw
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
http://www.Vivli.org
Learn more about this trial
A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
We'll reach out to this number within 24 hrs