A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2)
A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2)
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week Follow-up Period. Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group period. Period 2 is the long-term period and starts at Week 24. To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. At Week 28 and for the remaining dosing visits (to Week 316), all participants receive open-label risankizumab 150 mg every 12 weeks. Participants remain blinded to the original randomization allocation for the duration of the study. The total study duration is 336 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.
Inclusion Criteria:
Exclusion Criteria:
Skokie, Illinois 60076, United States
Wheaton, Maryland 20902, United States
St Louis, Missouri 63119-3845, United States
Voorhees Township, New Jersey 08043, United States
Colleyville, Texas 76034, United States
Buenos Aires, Ciuadad Autonoma de Buenos Aires 1221, Argentina
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires 1199, Argentina
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1111, Argentina
Rosario, Santa Fe Province 2000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Miskolc, Borsod-Abauj Zemplen county 3529, Hungary
Szeged, Csongrád megye 6725, Hungary
Modena, Emilia-Romagna 41124, Italy
Burwood Christchurch, 8083, New Zealand
Gdansk, Pomeranian Voivodeship 80-546, Poland
Ponte de Lima, Viana do Castelo District 4990-041, Portugal
Lisbon, 1649-035, Portugal
Metropolitan Borough of Wirral, CH49 5PE, United Kingdom