A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
BE TOGETHER
A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
3 other identifiers
interventional
168
11 countries
50
Brief Summary
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2024
Longer than P75 for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2024
CompletedFirst Posted
Study publicly available on registry
May 22, 2024
CompletedStudy Start
First participant enrolled
June 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 8, 2030
April 13, 2026
April 1, 2026
4.2 years
May 2, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Psoriasis Area Severity Index 90 (PASI90) 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.
Week 16
Investigator´s Global Assessment (IGA) 0/1 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, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, 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.
Week 16
Secondary Outcomes (32)
PASI75 response at Week 4
Week 4
PASI100 response at Week 16
Week 16
PASI90 response at Week 48
Week 48
IGA 0/1 response at Week 48
Week 48
PASI100 response at Week 48
Week 48
- +27 more secondary outcomes
Study Arms (2)
bimekizumab
EXPERIMENTALStudy participants randomized to this arm receive bimekizumab dosage regimen 1 at pre-specified timepoints during the Initial Treatment Period (16 weeks). They continue to receive bimekizumab dosage regimen 2 in the Maintenance Period (32 weeks). Under certain conditions study participants may be offered to continue on bimekizumab dosage regimen 2 in the Open-label Extension (OLE) Period (104 weeks).
ustekinumab
ACTIVE COMPARATORStudy participants randomized to this arm receive ustekinumab at pre-specified timepoints during the Initial Treatment Period (16 weeks) and during the Maintenance Period. Under certain conditions participants may switch to bimekizumab dosage regimen 1 (16 weeks) and continue with bimekizumab dosage regimen 2 in the last 16 weeks of the Maintenance Period. Under certain conditions study participants may be offered to participate in the OLE Period also receiving bimekizumab dosage regimen 2.
Interventions
Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.
Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.
Eligibility Criteria
You may qualify if:
- Study participant must be 6 to \<18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation
- Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit
- Study participant meets the following at both the Screening and Baseline Visits:
- 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
- Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling
- Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening
You may not qualify if:
- Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1 biologic response modifier other than an IL-17
- Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO
- Study 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
- Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
- Study participant has previously received bimekizumab
- Study participant has previously received ustekinumab
- Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
- Study participant has the presence of active suicidal ideation, or positive suicide behavior
- Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded
- Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Ps0021 50162
Fountain Valley, California, 92708, United States
Ps0021 50161
Los Angeles, California, 90045, United States
Ps0021 50196
Northridge, California, 91325, United States
Ps0021 50581
Miami, Florida, 33165, United States
Ps0021 50344
Indianapolis, Indiana, 46250, United States
Ps0021 50599
Kew Gardens, New York, 11415, United States
Ps0021 50084
Charleston, South Carolina, 29425, United States
Ps0021 50201
Arlington, Texas, 76011, United States
Ps0021 50355
Dallas, Texas, 75235, United States
Ps0021 40121
Brussels, Belgium
Ps0021 40420
Liège, Belgium
Ps0021 50618
Mississauga, Canada
Ps0021 50357
St. John's, Canada
Ps0021 50617
St. John's, Canada
Ps0021 40748
Plzen-bory, Czechia
Ps0021 40742
Argenteuil, France
Ps0021 40754
Nantes, France
Ps0021 40740
Bad Bentheim, Germany
Ps0021 40515
Berlin, Germany
Ps0021 40138
Bonn, Germany
Ps0021 40356
Dresden, Germany
Ps0021 40023
Erlangen, Germany
Ps0021 40645
Frankfurt am Main, Germany
Ps0021 40758
Hamburg, Germany
Ps0021 40249
Kiel, Germany
Ps0021 40747
Mainz, Germany
Ps0021 40177
Münster, Germany
Ps0021 40746
Debrecen, Hungary
Ps0021 40744
Kaposvár, Hungary
Ps0021 40745
Szeged, Hungary
Ps0021 40440
Ancona, Località Torrette, Italy
Ps0021 40749
Catania, Italy
Ps0021 40085
Pisa, Italy
Ps0021 40567
Roma, Italy
Ps0021 20071
Nagasaki, Japan
Ps0021 20033
Nagoya, Japan
Ps0021 20337
Shimotsuga-gun, Japan
Ps0021 40741
Bialystok, Poland
Ps0021 40832
Lodz, Poland
Ps0021 40091
Nowa Sól, Poland
Ps0021 40737
Rzeszów, Poland
Ps0021 40743
Szczecin, Poland
Ps0021 40625
Warsaw, Poland
Ps0021 40334
Wroclaw, Poland
Ps0021 40738
Wroclaw, Poland
Ps0021 40750
Alicante, Spain
Ps0021 40159
Barcelona, Spain
Ps0021 40751
Esplugues de Llobregat, Spain
Ps0021 40752
Granada, Spain
Ps0021 40753
Santiago de Compostela, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2024
First Posted
May 22, 2024
Study Start
June 25, 2024
Primary Completion (Estimated)
August 21, 2028
Study Completion (Estimated)
November 8, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this study 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.
- 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.
Data from this study 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 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. This plan may change if a determination is made that the data cannot be adequately anonymized.