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New psoriasis drug shows promise for kids in Head-to-Head trial

NCT ID NCT06425549

Disease control Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This study tests a new medicine called bimekizumab against an existing one (ustekinumab) for children and teens aged 6 to 17 with moderate to severe plaque psoriasis. The goal is to see if bimekizumab works better at clearing skin symptoms. About 168 participants will receive injections and be monitored for improvement and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

176 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate to severe plaque psoriasis

Contacts and locations

Locations

  • Ps0021 20033

    Nagoya, Japan

  • Ps0021 20071

    Nagasaki, Japan

  • Ps0021 20337

    Shimotsuga-gun, Japan

  • Ps0021 40023

    Erlangen, Germany

  • Ps0021 40085

    Pisa, Italy

  • Ps0021 40091

    Nowa Sól, Poland

  • Ps0021 40121

    Brussels, Belgium

  • Ps0021 40138

    Bonn, Germany

  • Ps0021 40177

    Münster, Germany

  • Ps0021 40249

    Kiel, Germany

  • Ps0021 40334

    Wroclaw, Poland

  • Ps0021 40356

    Dresden, Germany

  • Ps0021 40440

    Ancona, Località Torrette, Italy

  • Ps0021 40515

    Berlin, Germany

  • Ps0021 40567

    Roma, Italy

  • Ps0021 40625

    Lodz, Poland

  • Ps0021 40645

    Frankfurt am Main, Germany

  • Ps0021 40737

    Rzeszów, Poland

  • Ps0021 40738

    Wroclaw, Poland

  • Ps0021 40740

    Bad Bentheim, Germany

  • Ps0021 40741

    Bialystok, Poland

  • Ps0021 40743

    Szczecin, Poland

  • Ps0021 40744

    Kaposvár, Hungary

  • Ps0021 40745

    Szeged, Hungary

  • Ps0021 40746

    Debrecen, Hungary

  • Ps0021 40747

    Mainz, Germany

  • Ps0021 40748

    Plzen-bory, Czechia

  • Ps0021 40749

    Catania, Italy

  • Ps0021 40750

    Alicante, Spain

  • Ps0021 40751

    Esplugues de Llobregat, Spain

  • Ps0021 40752

    Granada, Spain

  • Ps0021 40758

    Hamburg, Germany

  • Ps0021 40832

    Lodz, Poland

  • Ps0021 50084

    Charleston, South Carolina, 29425, United States

  • Ps0021 50161

    Los Angeles, California, 90045, United States

  • Ps0021 50162

    Fountain Valley, California, 92708, United States

  • Ps0021 50196

    Northridge, California, 91325, United States

  • Ps0021 50201

    Arlington, Texas, 76011, United States

  • Ps0021 50344

    Indianapolis, Indiana, 46250, United States

  • Ps0021 50355

    Dallas, Texas, 75235, United States

  • Ps0021 50357

    St. John's, Canada

  • Ps0021 50618

    Mississauga, Canada

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