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A 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)
EU CTIS ID: 2023-505478-14-00
What this study is testing
Period 1 Double-Blind - To compare the efficacy of risankizumab 150 mg versus placebo for the treatment of signs and symptoms of PsA in the study population
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- Bosnia and Herzegovina
- Puerto Rico
- Taiwan
- Singapore
- Korea, Republic of
- South Africa
- Israel
- Russian Federation
- United States
- Brazil
- Australia
- Malaysia
- Serbia
- Chile
- Canada
- Mexico
- Argentina
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ukraine; Bosnia and Herzegovina; Puerto Rico; Taiwan; Singapore; Korea, Republic of and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.