Clinical trial

A Multicenter, 48-Week, Double-Blind, Placebo-Controlled, Parallel-Group Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Name

PS0011

Description

This is a multicenter extension study to assess the long-term safety, tolerability and efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Trial arms

Trial start

2016-12-14

Estimated PCD

2018-09-25

Trial end

2018-09-25

Status

Completed

Phase

Early phase I

Treatment

Bimekizumab

Subjects will receive bimekizumab injections every four weeks (Q4W)

Arms:

Bimekizumab dosing regimen 1, Bimekizumab dosing regimen 2, Bimekizumab dosing regimen 3

Other names:

UCB4940

Placebo

Subjects will receive Placebo injections every four weeks (Q4W)

Arms:

Placebo

Size

217

Primary endpoint

Incidence of Treatment Emergent Adverse Events (TEAEs) Adjusted by Duration of Subject Exposure to Treatment

From Baseline until Safety Follow-Up Visit (up to Week 64)

Eligibility criteria

Inclusion Criteria: * Subject has provided informed consent * Subject completes all dosing requirements in feeder study and completes PS0010 study without meeting any withdrawal criteria * Female subjects of childbearing potential and male subjects with a partner of childbearing potential must continue to use an acceptable method of contraception (as detailed in PS0010) for up to 20 weeks after the last dose of study treatment in PS0011 Exclusion Criteria: * Subject has previously participated in this study. * Female subjects who plan to become pregnant during the study or within 20 weeks following last dose of study medication. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose * Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. * Subject must have a negative interferon gamma release assay (IGRA) as measured at Week 8 of PS0010

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 217, 'type': 'ACTUAL'}}

Updated at

2022-10-18

1 organization

1 product

1 indication

Organization

UCB Biopharma

Product

Bimekizumab

Indication

Psoriasis