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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
NCT06425549 · UCB Pharma
In plain English
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Official title
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
About this study
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).
Eligibility criteria
Inclusion Criteria:
* 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:
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
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
Exclusion Criteria:
* 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
Study design
Enrollment target: 168 participants
Allocation: randomized
Masking: quadruple
Age groups: child
Timeline
Starts: 2024-06-25
Estimated completion: 2030-11-08
Last updated: 2026-04-13
Interventions
Drug: bimekizumabDrug: ustekinumabDrug: placebo
Primary outcomes
- • Psoriasis Area Severity Index 90 (PASI90) response at Week 16 (Week 16)
- • Investigator´s Global Assessment (IGA) 0/1 response at Week 16 (Week 16)
Sponsor
UCB Biopharma SRL · industry
Contacts & investigators
ContactUCB Cares · contact · ucbcares@ucb.com · 1-844-599-2273 (USA)
ContactUCB Cares · contact · UCBCares@ucb.com · 001 844 599 2273
InvestigatorUCB Cares · study_director, 001 844 599 2273
All locations (50)
Ps0021 50162Active Not Recruiting
Fountain Valley, California, United States
Ps0021 50161Active Not Recruiting
Los Angeles, California, United States
Ps0021 50196Completed
Northridge, California, United States
Ps0021 50581Recruiting
Miami, Florida, United States
Ps0021 50344Active Not Recruiting
Indianapolis, Indiana, United States
Ps0021 50599Recruiting
Kew Gardens, New York, United States
Ps0021 50084Active Not Recruiting
Charleston, South Carolina, United States
Ps0021 50201Completed
Arlington, Texas, United States
Ps0021 50355Active Not Recruiting
Dallas, Texas, United States
Ps0021 40121Active Not Recruiting
Brussels, Belgium
Ps0021 40420Recruiting
Liège, Belgium
Ps0021 50618Active Not Recruiting
Mississauga, Canada
Ps0021 50357Active Not Recruiting
St. John's, Canada
Ps0021 50617Recruiting
St. John's, Canada
Ps0021 40748Active Not Recruiting
Plzen-bory, Czechia
Ps0021 40742Recruiting
Argenteuil, France
Ps0021 40754Recruiting
Nantes, France
Ps0021 40740Active Not Recruiting
Bad Bentheim, Germany
Ps0021 40515Completed
Berlin, Germany
Ps0021 40138Active Not Recruiting
Bonn, Germany
Ps0021 40356Active Not Recruiting
Dresden, Germany
Ps0021 40023Active Not Recruiting
Erlangen, Germany
Ps0021 40645Active Not Recruiting
Frankfurt am Main, Germany
Ps0021 40758Active Not Recruiting
Hamburg, Germany
Ps0021 40249Active Not Recruiting
Kiel, Germany
Ps0021 40747Completed
Mainz, Germany
Ps0021 40177Active Not Recruiting
Münster, Germany
Ps0021 40746Active Not Recruiting
Debrecen, Hungary
Ps0021 40744Active Not Recruiting
Kaposvár, Hungary
Ps0021 40745Active Not Recruiting
Szeged, Hungary
Ps0021 40440Active Not Recruiting
Ancona, Località Torrette, Italy
Ps0021 40749Active Not Recruiting
Catania, Italy
Ps0021 40085Active Not Recruiting
Pisa, Italy
Ps0021 40567Active Not Recruiting
Roma, Italy
Ps0021 20071Recruiting
Nagasaki, Japan
Ps0021 20033Recruiting
Nagoya, Japan
Ps0021 20337Recruiting
Shimotsuga-gun, Japan
Ps0021 40741Active Not Recruiting
Bialystok, Poland
Ps0021 40832Active Not Recruiting
Lodz, Poland
Ps0021 40091Active Not Recruiting
Nowa Sól, Poland
Ps0021 40737Active Not Recruiting
Rzeszów, Poland
Ps0021 40743Active Not Recruiting
Szczecin, Poland
Ps0021 40625Active Not Recruiting
Warsaw, Poland
Ps0021 40334Active Not Recruiting
Wroclaw, Poland
Ps0021 40738Active Not Recruiting
Wroclaw, Poland
Ps0021 40750Active Not Recruiting
Alicante, Spain
Ps0021 40159Recruiting
Barcelona, Spain
Ps0021 40751Active Not Recruiting
Esplugues de Llobregat, Spain
Ps0021 40752Active Not Recruiting
Granada, Spain
Ps0021 40753Recruiting
Santiago de Compostela, Spain