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

Last updated: May 7, 2026
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

3

Condition

Rash

Warts

Rosacea

Treatment

bimekizumab

ustekinumab

placebo

Clinical Study ID

NCT06425549
PS0021
U1111-1293-2383
2023-503859-10-00
  • Ages 6-17
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Study participant must be 6 to <18 years of age, inclusive, at the time of signingthe 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/chemotherapyand 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

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 1biologic response modifier other than an IL-17

  • Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSOor other dermatological condition that may impact the clinical assessment of PSO

  • Study participant has a history of inflammatory bowel disease (IBD) or symptomssuggestive of IBD

  • History of active tuberculosis unless successfully treated, latent TB unlessprophylactically treated

  • Study participant has an active infection or history of infections (such as seriousinfection, chronic infections, opportunistic infections, unusually severeinfections)

  • Study participant has previously received bimekizumab

  • Study participant has previously received ustekinumab

  • Study participant has received drugs outside the specified timeframes relative tothe Baseline Visit or receives prohibited concomitant treatments

  • Study participant has the presence of active suicidal ideation, or positive suicidebehavior

  • Study participant diagnosed with severe depression in the past 6 months (prior toScreening) should be excluded

  • Study participant has a history of psychiatric inpatient hospitalization within thepast year before enrolling into the study

Study Design

Total Participants: 168
Treatment Group(s): 3
Primary Treatment: bimekizumab
Phase: 3
Study Start date:
June 25, 2024
Estimated Completion Date:
November 08, 2030

Connect with a study center

  • Ps0021 40121

    Brussels,
    Belgium

    Site Not Available

  • Ps0021 40121

    Brussels 2800866,
    Belgium

    Site Not Available

  • Ps0021 40121

    Bruxelles,
    Belgium

    Site Not Available

  • Ps0021 40420

    Liege,
    Belgium

    Site Not Available

  • Ps0021 40420

    Liège,
    Belgium

    Site Not Available

  • Ps0021 40420

    Liège 2792413,
    Belgium

    Site Not Available

  • Ps0021 50618

    Mississauga,
    Canada

    Site Not Available

  • Ps0021 50618

    Mississauga 6075357,
    Canada

    Site Not Available

  • Ps0021 50617

    St- John's,
    Canada

    Site Not Available

  • Ps0021 50357

    St. John's,
    Canada

    Site Not Available

  • Ps0021 50617

    St. John's,
    Canada

    Site Not Available

  • Ps0021 50357

    St. John's 6324733,
    Canada

    Site Not Available

  • Ps0021 50617

    St. John's 6324733,
    Canada

    Active - Recruiting

  • Ps0021 40748

    Plzen,
    Czechia

    Site Not Available

  • Ps0021 40748

    Plzen-bory,
    Czechia

    Site Not Available

  • Ps0021 40742

    Argenteuil,
    France

    Site Not Available

  • Ps0021 40742

    Argenteuil 3037044,
    France

    Site Not Available

  • Ps0021 40754

    Nantes,
    France

    Site Not Available

  • Ps0021 40754

    Nantes 2990969,
    France

    Site Not Available

  • Ps0021 40138

    Adenau,
    Germany

    Site Not Available

  • Ps0021 40740

    Bad Bentheim,
    Germany

    Site Not Available

  • Ps0021 40740

    Bad Bentheim 2953552,
    Germany

    Site Not Available

  • Ps0021 40515

    Berlin,
    Germany

    Completed

  • Ps0021 40515

    Berlin 2950159,
    Germany

    Site Not Available

  • Ps0021 40138

    Bonn,
    Germany

    Site Not Available

  • Ps0021 40138

    Bonn 2946447,
    Germany

    Site Not Available

  • Ps0021 40356

    Dresden,
    Germany

    Site Not Available

  • Ps0021 40356

    Dresden 2935022,
    Germany

    Site Not Available

  • Ps0021 40023

    Erlangen,
    Germany

    Completed

  • Ps0021 40023

    Erlangen 2929567,
    Germany

    Site Not Available

  • Ps0021 40645

    Frankfurt am Main,
    Germany

    Site Not Available

  • Ps0021 40645

    Frankfurt am Main 2925533,
    Germany

    Site Not Available

  • Ps0021 40645

    Frankfurt/main,
    Germany

    Site Not Available

  • Ps0021 40758

    Hamburg,
    Germany

    Site Not Available

  • Ps0021 40758

    Hamburg 2911298,
    Germany

    Site Not Available

  • Ps0021 40249

    Kiel,
    Germany

    Site Not Available

  • Ps0021 40249

    Kiel 2891122,
    Germany

    Site Not Available

  • Ps0021 40747

    Mainz,
    Germany

    Completed

  • Ps0021 40747

    Mainz 2874225,
    Germany

    Site Not Available

  • Ps0021 40177

    Muenster,
    Germany

    Site Not Available

  • Ps0021 40177

    Münster,
    Germany

    Site Not Available

  • Ps0021 40177

    Münster 2867543,
    Germany

    Site Not Available

  • Ps0021 40746

    Debrecen,
    Hungary

    Site Not Available

  • Ps0021 40746

    Debrecen 721472,
    Hungary

    Site Not Available

  • Ps0021 40744

    Kaposvár,
    Hungary

    Site Not Available

  • Ps0021 40744

    Kaposvár 3050616,
    Hungary

    Site Not Available

  • Ps0021 40745

    Szeged,
    Hungary

    Site Not Available

  • Ps0021 40745

    Szeged 715429,
    Hungary

    Site Not Available

  • Ps0021 40440

    Ancona, Località Torrette,
    Italy

    Site Not Available

  • Ps0021 40440

    Ancona, Località Torrette 3183089,
    Italy

    Site Not Available

  • Ps0021 40749

    Catania,
    Italy

    Site Not Available

  • Ps0021 40749

    Catania 2525068,
    Italy

    Site Not Available

  • Ps0021 40085

    Pisa,
    Italy

    Site Not Available

  • Ps0021 40085

    Pisa 3170647,
    Italy

    Site Not Available

  • Ps0021 40567

    Roma,
    Italy

    Site Not Available

  • Ps0021 40567

    Roma 8957247,
    Italy

    Site Not Available

  • Ps0021 40440

    Torrette DI Ancona,
    Italy

    Site Not Available

  • Ps0021 20071

    Nagasaki,
    Japan

    Active - Recruiting

  • Ps0021 20071

    Nagasaki 1856177,
    Japan

    Site Not Available

  • Ps0021 20033

    Nagoya,
    Japan

    Active - Recruiting

  • Ps0021 20033

    Nagoya 1856057,
    Japan

    Site Not Available

  • Ps0021 20337

    Shimotsuga-gun,
    Japan

    Active - Recruiting

  • Ps0021 40741

    Bialystok,
    Poland

    Site Not Available

  • Ps0021 40741

    Bialystok 776069,
    Poland

    Site Not Available

  • Ps0021 40625

    Lodz,
    Poland

    Site Not Available

  • Ps0021 40832

    Lodz,
    Poland

    Site Not Available

  • Ps0021 40625

    Lodz 3093133,
    Poland

    Site Not Available

  • Ps0021 40832

    Lodz 3093133,
    Poland

    Site Not Available

  • Ps0021 40091

    Nowa Sol,
    Poland

    Site Not Available

  • Ps0021 40091

    Nowa Sól,
    Poland

    Site Not Available

  • Ps0021 40091

    Nowa Sól 3090764,
    Poland

    Site Not Available

  • Ps0021 40737

    Rzeszow,
    Poland

    Site Not Available

  • Ps0021 40737

    Rzeszów,
    Poland

    Site Not Available

  • Ps0021 40737

    Rzeszów 759734,
    Poland

    Site Not Available

  • Ps0021 40743

    Szczecin,
    Poland

    Site Not Available

  • Ps0021 40743

    Szczecin 3083829,
    Poland

    Site Not Available

  • Ps0021 40625

    Warsaw,
    Poland

    Site Not Available

  • Ps0021 40625

    Warsaw 756135,
    Poland

    Site Not Available

  • Ps0021 40334

    Wroclaw,
    Poland

    Site Not Available

  • Ps0021 40738

    Wroclaw,
    Poland

    Site Not Available

  • Ps0021 40334

    Wroclaw 3081368,
    Poland

    Site Not Available

  • Ps0021 40738

    Wroclaw 3081368,
    Poland

    Site Not Available

  • Ps0021 40750

    Alicante,
    Spain

    Site Not Available

  • Ps0021 40750

    Alicante 2521978,
    Spain

    Site Not Available

  • Ps0021 40159

    Barcelona,
    Spain

    Site Not Available

  • Ps0021 40159

    Barcelona 3128760,
    Spain

    Site Not Available

  • Ps0021 40751

    Esplugues de Llobregat,
    Spain

    Site Not Available

  • Ps0021 40751

    Esplugues de Llobregat 3122826,
    Spain

    Site Not Available

  • Ps0021 40752

    Granada,
    Spain

    Site Not Available

  • Ps0021 40752

    Granada 2517117,
    Spain

    Site Not Available

  • Ps0021 40753

    Santiago de Compostela,
    Spain

    Site Not Available

  • Ps0021 40753

    Santiago de Compostela 3109642,
    Spain

    Site Not Available

  • Ps0021 50162

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Ps0021 50161

    Los Angeles, California 90045
    United States

    Site Not Available

  • Ps0021 50196

    Northridge, California 91325
    United States

    Completed

  • Ps0021 50162

    Fountain Valley 5350207, California 5332921 92708
    United States

    Site Not Available

  • Ps0021 50161

    Los Angeles 5368361, California 5332921 90045
    United States

    Site Not Available

  • Ps0021 50196

    Northridge 5377985, California 5332921 91325
    United States

    Site Not Available

  • Ps0021 50581

    Miami, Florida 33165
    United States

    Site Not Available

  • Ps0021 50581

    Miami 4164138, Florida 4155751 33165
    United States

    Site Not Available

  • Ps0021 50344

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Ps0021 50344

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Site Not Available

  • Ps0021 50599

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Ps0021 50599

    Kew Gardens 5123344, New York 5128638 11415
    United States

    Site Not Available

  • Ps0021 50084

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Ps0021 50084

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Ps0021 50201

    Arlington, Texas 76011
    United States

    Completed

  • Ps0021 50355

    Dallas, Texas 75235
    United States

    Site Not Available

  • Ps0021 50201

    Arlington 4671240, Texas 4736286 76011
    United States

    Site Not Available

  • Ps0021 50355

    Dallas 4684888, Texas 4736286 75235
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.