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-PL
- 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 Main Objective: The primary objective of Study M15-997 is to investigate long-term safety and tolerability of risankizumab in subjects with psoriasis who have completed one of the preceding Phase 2/3 studies. ;Secondary Objective: The secondary objective of Study M15-997 is to investigate the long-term efficacy of risankizumab in the treatment of psoriasis.;Primary end point(s): Achievement of PASI 90;Timepoint(s) of evaluation of this end point: Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 132, Week 144, Week 156, Week 180, Week 204, Week 228, Week 252, End of Observation visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Achievement of PASI 75 or 100 and achievement of sPGA score of clear or almost clear;Timepoint(s) of evaluation of this end point: Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 132, Week 144, Week 156, Week 180, Week 204, Week 228, Week 252, End of Observation visit