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

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma SRL

Criteria

Inclusion Criteria:

• Participant must be ≥12 to <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