NCT04718896CompletedPhase 2
A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
The purpose of the study is to assess th pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 18 Jan 2021
- Start date
- 6 Apr 2021
- Primary completion date
- 12 Mar 2025
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Psoriasis
- NCT number
- NCT04718896
- EU CT number
- 2023-509832-24-00
- EudraCT number
- 2020-001724-34
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 41
- From 6 Apr 2021 to the primary completion date, 12 Mar 2025
- 11 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 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
Lab values
- Participant has laboratory abnormalities at Screening
Other
- Presence of active suicidal ideation, or positive suicide behavior
- Participant has been diagnosed with severe depression in the past 6 months
Who the study is looking for
- 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:
- Body surface area (BSA) affected by PSO ≥10%
- Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
- Psoriasis Area and Severity Index (PASI) score ≥12 OR
- PASI score ≥10 plus at least 1 of the following:
- 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)
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ps0020 50354 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Ps0020 50357 Coordinator of this site? Confirm its status | St. John's | Canada | Unknown status |
| Universitaetsklinikum Frankfurt AöR Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Completed |
| Specderm Poznanska sp.j. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| DERMED Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| dermMedica Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Ps0020 50359 Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
| Ps0020 50344 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.