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Evaluating bimekizumab for treating plaque psoriasis in children and adolescents

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

Phase 3 Interventional UCB Pharma · NCT06425549

This study is testing if a new medication called bimekizumab can work better than the standard treatment for plaque psoriasis in children and teens aged 6 to under 18.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment168 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorUCB Pharma Industry-sponsored
Drugs / interventionsustekinumab, brodalumab, ixekizumab, secukinumab, bimekizumab, chemotherapy
Locations50 sites (Fountain Valley, California and 49 other locations)
Trial IDNCT06425549 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of bimekizumab, administered subcutaneously, compared to ustekinumab in children and adolescents aged 6 to less than 18 years with moderate to severe plaque psoriasis. Participants must have a significant body surface area affected by psoriasis and meet specific severity criteria. The study aims to determine if bimekizumab is more effective than the standard treatment, ustekinumab, in this pediatric population.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 6 to less than 18 years with moderate to severe plaque psoriasis who meet specific severity criteria.

Not a fit: Patients with mild psoriasis or those who do not meet the inclusion criteria for severity and age may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for children and adolescents suffering from moderate to severe plaque psoriasis.

How similar studies have performed: Other studies have shown promising results with similar biologic treatments for psoriasis, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Fountain Valley, California and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate to Severe Plaque PsoriasisbimekizumabBKZustekinumabpaediatric study participantschildrenadolescentsPsoriasis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.