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

NCT04718896 | Completed Phase 2 DMC FDA Drug

• 4 other identifiers: PS00202020-001724-342023-509832-24U1111-1303-1875
• Study Type: interventional
• Target: 41
• Locations: 4 countries
• Sites: 11

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

Keywords

bimekizumab; BKZ; adolescent study participants; psoriasis; PSO

Outcome Measures

Primary Outcomes (14)

• Plasma concentration of bimekizumab at Week 0

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 0.

  Baseline (Week 0)

• Plasma concentration of bimekizumab at Week 1

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 1.

  Week 1

• Plasma concentration of bimekizumab at Week 4

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 4.

  Week 4

• Plasma concentration of bimekizumab at Week 8

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 8.

  Week 8

• Plasma concentration of bimekizumab at Week 12

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 12.

  Week 12

• Plasma concentration of bimekizumab at Week 16

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 16.

  Week 16

• Plasma concentration of bimekizumab at Week 20

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 20.

  Week 20

• Plasma concentration of bimekizumab at Week 36

  Blood samples will be collected at pre-specified time points at Week 36 to determine the bimekizumab plasma concentration, if participant is not eligible for the Open-label Extension (OLE) Period at Week 20 or does not wish to continue into the OLE Period.

  Week 36

• Plasma concentration of bimekizumab at Week 40

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 40.

  Week 40

• Plasma concentration of bimekizumab at Week 64

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 64.

  Week 64

• Plasma concentration of bimekizumab at Week 88

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 88.

  Week 88

• Plasma concentration of bimekizumab at Week 112

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 112.

  Week 112

• Plasma concentration of bimekizumab at Week 124

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 124.

  Week 124

• Plasma concentration of bimekizumab at safety follow up (SFU)

  Blood samples will be collected at pre-specified time points to determine the bimekizumab plasma concentration at Week 140 (SFU).

  Week 140 (SFU)

Secondary Outcomes (27)

• Percentage of participants with treatment-emergent adverse events (TEAEs)

  From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)]

• Percentage of participants with serious TEAEs

  From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)

• Percentage of participants with TEAEs leading to discontinuation of investigational medicinal product (IMP)

  From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)

• Percentage of participants with selected safety topics of interest

  From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)

• Change from Baseline in vital signs (systolic and diastolic blood pressure)

  From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)

Study Arms (2)

Bimekizumab Dose A

EXPERIMENTAL

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

Drug: bimekizumab

Bimekizumab Dose B

EXPERIMENTAL

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

Drug: bimekizumab

Interventions

bimekizumab DRUG

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

Also known as: BKZ, UCB4940

Bimekizumab Dose A; Bimekizumab Dose B

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (11)

Ps0020 50344

Indianapolis, Indiana, 46250, United States

Location

Ps0020 50359

Cypress, Texas, 77433, United States

Location

Ps0020 50354

Calgary, Canada

Location

Ps0020 50357

St. John's, Canada

Location

Ps0020 40645

Frankfurt, Germany

Location

Ps0020 40626

Bialystok, Poland

Location

Ps0020 40625

Lodz, Poland

Location

Ps0020 40396

Rzeszów, Poland

Location

Ps0020 40335

Warsaw, Poland

Location

Ps0020 40333

Wroclaw, Poland

Location

Ps0020 40334

Wroclaw, Poland

Location

MeSH Terms

Conditions

Psoriasis

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: April 6, 2021
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

US (2); CA (2); PL (6); DE (1)