New psoriasis drug shows promise for teens in early trial
NCT ID NCT04718896
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 Hide 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
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Ps0020 40334
Wroclaw, Poland
-
Ps0020 40335
Warsaw, Poland
-
Ps0020 40396
Rzeszów, Poland
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Ps0020 40625
Lodz, Poland
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Ps0020 40626
Bialystok, Poland
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Ps0020 40645
Frankfurt, Germany
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Ps0020 50344
Indianapolis, Indiana, 46250, United States
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Ps0020 50354
Calgary, Canada
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Ps0020 50357
St. John's, Canada
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Ps0020 50359
Cypress, Texas, 77433, United States
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