Study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in patients with chronic plaque psoriasis.

Phase 1

• Conditions: Chronic plaque psoriasis; MedDRA version: 19.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-001892-57-CZ
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-12
• Study Completion: 2018-09-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 217

Inclusion Criteria

- Subject has provided informed consent.
- Subject completes all dosing requirements in feeder study and completes PS0010 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 of 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the long-term safety and tolerability of bimekizumab.;Secondary Objective: Assess the efficacy of bimekizumab administered every 4 weeks (Q4W) over 48 weeks.;Primary end point(s): Incidence of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to treatment;Timepoint(s) of evaluation of this end point: From Baseline until Safety Follow Up Visit (up to Week 64)

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - Change from Baseline in Psoriasis Area Severity Index (PAS190) response over time<br> - Change from Baseline in Investigator´s Global Assessment over time<br> ;Timepoint(s) of evaluation of this end point: From Baseline during the Treatment Period (up to Week 48)