A multicenter, open label study to assess the safety and efficacy of risankizumab for maintenance in moderate to severe plaque type psoriasis
Phase 1
- Conditions
- PsoriasisMedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2016-003046-87-PT
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2200
Inclusion Criteria
1. Subjects with moderate to severe chronic plaque psoriasis who have completed one of the preceding studies 1311.3, 1311.4, 1311.13, 1311.28, 1311.30, 1311.38 and M16-178.
2. Subjects must be candidates for prolonged open label risankizumab treatment according to investigator judgment
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 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
Exclusion Criteria
1. Premature discontinuation for any reason in the preceding study.
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