A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis

Completed · Phase 2

Conditions studied: Moderate to Severe Plaque Psoriasis

In brief

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).

Key facts

Study ID

NCT04718896

Run by

UCB Biopharma SRL

People needed

41

Starts

2021-04-06

Expected to finish

2025-03-12

Last updated by the study team

2026-08-03

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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)

You may not qualify if…

• 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

Where it is running

• Ps0020 50344 — Indianapolis, Indiana, United States
• Ps0020 50359 — Cypress, Texas, United States
• Ps0020 50354 — Calgary, Canada
• Ps0020 50357 — St. John's, Canada
• Ps0020 40645 — Frankfurt, Germany
• Ps0020 40626 — Bialystok, Poland
• Ps0020 40625 — Lodz, Poland
• Ps0020 40396 — Rzeszów, Poland
• Ps0020 40335 — Warsaw, Poland
• Ps0020 40333 — Wroclaw, Poland
• Ps0020 40334 — Wroclaw, Poland

Full record on ClinicalTrials.gov

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