EUCTR2017-002465-22-SKActive, not recruitingPhase 1
A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects with Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1) - KEEPsAKE 1
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 880
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.
- •Subject has active disease at Baseline
- •Diagnosis of active plaque psoriasis with at least one psoriatic plaque of = 2 centimeter (cm) diameter or nail changes consistent with psoriasis at Screening Visit.
- •Presence of either at Screening:
- •1. = 1 erosion on radiograph as determined by central imaging review or;
- •2. hs-CRP = 3.0 mg/L.
- •Subject must have demonstrated an inadequate response (lack of efficacy after minimum 12 week duration of therapy) to previous or current treatment with at least 1 csDMARD at maximally tolerated dose.
- •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 712
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
Exclusion Criteria
- •Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
- •Subject has a known hypersensitivity to Risankizumab.
- •Subject has previous treatment with biologic agent.
Investigators
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