New psoriasis drug shows promise for teens in early trial

NCT ID NCT04718896

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tested two doses of bimekizumab, a drug that targets inflammation, in 41 adolescents aged 12 to 17 with moderate to severe plaque psoriasis. The main goals were to measure how the drug behaves in the body and to check its safety. Researchers also looked at how well it cleared skin plaques over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bimekizumab
What this could lead to
If successful, this could provide a new treatment option for teenagers with moderate to severe plaque psoriasis, helping clear their skin and improve quality of life.
What could go wrong
This is a small, early-phase trial (41 participants) focused on drug levels and safety, not yet proving long-term effectiveness. Side effects are possible, and results may not apply to all teens.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

41 people

The number who actually took part.

Started

Apr 2021

Finished

Mar 2025

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

12 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: * Participant must be ≥12 to less than 18 years of age at the time of signing the informed consent/assent according to local regulation * Participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit and: 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 4. 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 * Participant must be candidate for systemic PSO therapy and/or photo/chemotherapy * Body weight ≥30 kg and body mass index for age percentile of ≥5 at Baseline * Male or female A female participant will be eligible to participate if she is not pregnant, not breastfeeding, and a woman of childbearing potential (WOCBP) agrees to follow the contraceptive guidance * Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate) Exclusion Criteria: * Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO * 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 * Participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) * Participant has laboratory abnormalities at Screening * Participant has experienced primary failure to one or more interleukin-17 (IL-17) biologic response modifier OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier * Presence of active suicidal ideation, or positive suicide behavior * Participant has been diagnosed with severe depression in the past 6 months

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ps0020 40333

    Wroclaw, Poland

  • Ps0020 40334

    Wroclaw, Poland

  • Ps0020 40335

    Warsaw, Poland

  • Ps0020 40396

    Rzeszów, Poland

  • Ps0020 40625

    Lodz, Poland

  • Ps0020 40626

    Bialystok, Poland

  • Ps0020 40645

    Frankfurt, Germany

  • Ps0020 50344

    Indianapolis, Indiana, 46250, United States

  • Ps0020 50354

    Calgary, Canada

  • Ps0020 50357

    St. John's, Canada

  • Ps0020 50359

    Cypress, Texas, 77433, United States

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