Study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in patients with chronic plaque psoriasis.
- Conditions
- Chronic plaque psoriasisMedDRA version: 19.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-001892-57-HU
- Lead Sponsor
- CB Biopharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
- 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
- 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
- Secondary Outcome Measures
Name Time Method