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

NCT ID: NCT04718896

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2025-03-12

Brief 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).

Conditions

Moderate to Severe Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bimekizumab Dose A

Study participants randomized to this arm will receive bimekizumab (BKZ) Dose A at pre-specified time points during the study.

Group Type: EXPERIMENTAL

bimekizumab

Intervention Type: DRUG

Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.

Bimekizumab Dose B

Study participants randomized to this arm will receive bimekizumab (BKZ) Dose B at pre-specified time points during the study.

Group Type: EXPERIMENTAL

bimekizumab

Intervention Type: DRUG

Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.

Interventions

bimekizumab

Study participants will receive subcutaneously administered bimekizumab (BKZ) at pre-specified time points during the study.

Intervention Type: DRUG

Other Intervention Names

BKZ; UCB4940

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273

Locations

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

Countries

United States; Canada; Germany; Poland

Other Identifiers

2020-001724-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-509832-24

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1303-1875

Identifier Type: OTHER

Identifier Source: secondary_id

PS0020

Identifier Type: -

Identifier Source: org_study_id