Actively Recruiting
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
Led by UCB Biopharma SRL · Updated on 2026-05-08
168
Participants Needed
50
Research Sites
332 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 6 to less than 18 years old at the time of consent
- Diagnosed with moderate to severe plaque psoriasis for at least 3 months before screening
- Have at least 10% body surface area affected by psoriasis at screening and baseline
- Have an Investigator's Global Assessment score of 3 or higher at screening and baseline
- Have a Psoriasis Area and Severity Index score of 12 or higher, or at least 10 plus clinically relevant involvement of face, genital, or hands and feet
- Be a candidate for systemic psoriasis therapy and/or photo/chemotherapy and treatment with ustekinumab
- Have a body weight of at least 15 kg and body mass index for age percentile of 5 or higher at screening
You will not qualify if you...
- No response within 12 weeks to one or more interleukin-17 biologic treatments or more than one other biologic treatment
- Presence of guttate, inverse, pustular, or erythrodermic psoriasis or other skin conditions affecting assessment
- History or symptoms of inflammatory bowel disease
- History of active or latent tuberculosis unless successfully treated
- Active infection or history of serious, chronic, opportunistic, or severe infections
- Previous treatment with bimekizumab or ustekinumab
- Use of prohibited drugs outside specified timeframes relative to baseline or prohibited concurrent treatments
- Active suicidal thoughts or positive suicide behavior
- Diagnosis of severe depression in the past 6 months before screening
- Psychiatric inpatient hospitalization within the past year before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 50 locations
1
Ps0021 50162
Fountain Valley, California, United States, 92708
Active, Not Recruiting
2
Ps0021 50161
Los Angeles, California, United States, 90045
Active, Not Recruiting
3
Ps0021 50196
Northridge, California, United States, 91325
Completed
4
Ps0021 50581
Miami, Florida, United States, 33165
Withdrawn
5
Ps0021 50344
Indianapolis, Indiana, United States, 46250
Active, Not Recruiting
6
Ps0021 50599
Kew Gardens, New York, United States, 11415
Withdrawn
7
Ps0021 50084
Charleston, South Carolina, United States, 29425
Active, Not Recruiting
8
Ps0021 50201
Arlington, Texas, United States, 76011
Completed
9
Ps0021 50355
Dallas, Texas, United States, 75235
Active, Not Recruiting
10
Ps0021 40121
Brussels, Belgium
Active, Not Recruiting
11
Ps0021 40420
Liège, Belgium
Withdrawn
12
Ps0021 50618
Mississauga, Canada
Active, Not Recruiting
13
Ps0021 50357
St. John's, Canada
Active, Not Recruiting
14
Ps0021 50617
St. John's, Canada
Withdrawn
15
Ps0021 40748
Plzen-bory, Czechia
Active, Not Recruiting
16
Ps0021 40742
Argenteuil, France
Withdrawn
17
Ps0021 40754
Nantes, France
Withdrawn
18
Ps0021 40740
Bad Bentheim, Germany
Active, Not Recruiting
19
Ps0021 40515
Berlin, Germany
Completed
20
Ps0021 40138
Bonn, Germany
Active, Not Recruiting
21
Ps0021 40356
Dresden, Germany
Active, Not Recruiting
22
Ps0021 40023
Erlangen, Germany
Completed
23
Ps0021 40645
Frankfurt am Main, Germany
Active, Not Recruiting
24
Ps0021 40758
Hamburg, Germany
Active, Not Recruiting
25
Ps0021 40249
Kiel, Germany
Active, Not Recruiting
26
Ps0021 40747
Mainz, Germany
Completed
27
Ps0021 40177
Münster, Germany
Active, Not Recruiting
28
Ps0021 40746
Debrecen, Hungary
Active, Not Recruiting
29
Ps0021 40744
Kaposvár, Hungary
Active, Not Recruiting
30
Ps0021 40745
Szeged, Hungary
Active, Not Recruiting
31
Ps0021 40440
Ancona, Località Torrette, Italy
Active, Not Recruiting
32
Ps0021 40749
Catania, Italy
Active, Not Recruiting
33
Ps0021 40085
Pisa, Italy
Active, Not Recruiting
34
Ps0021 40567
Roma, Italy
Active, Not Recruiting
35
Ps0021 20071
Nagasaki, Japan
Actively Recruiting
36
Ps0021 20033
Nagoya, Japan
Actively Recruiting
37
Ps0021 20337
Shimotsuga-gun, Japan
Actively Recruiting
38
Ps0021 40741
Bialystok, Poland
Active, Not Recruiting
39
Ps0021 40832
Lodz, Poland
Active, Not Recruiting
40
Ps0021 40091
Nowa Sól, Poland
Active, Not Recruiting
41
Ps0021 40737
Rzeszów, Poland
Active, Not Recruiting
42
Ps0021 40743
Szczecin, Poland
Active, Not Recruiting
43
Ps0021 40625
Warsaw, Poland
Active, Not Recruiting
44
Ps0021 40334
Wroclaw, Poland
Active, Not Recruiting
45
Ps0021 40738
Wroclaw, Poland
Active, Not Recruiting
46
Ps0021 40750
Alicante, Spain
Active, Not Recruiting
47
Ps0021 40159
Barcelona, Spain
Withdrawn
48
Ps0021 40751
Esplugues de Llobregat, Spain
Active, Not Recruiting
49
Ps0021 40752
Granada, Spain
Active, Not Recruiting
50
Ps0021 40753
Santiago de Compostela, Spain
Withdrawn
Research Team
U
UCB Cares
CONTACT
U
UCB Cares
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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