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)
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)
The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants 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 treatment period. Period 2 is the long-term treatment 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 are to receive open-label risankizumab 150 mg every 12 weeks. Participants will 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:
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.
Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts)
Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit.
Participant has demonstrated an inadequate response or intolerance to or contraindication for conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
Presence of either at Screening:
Exclusion Criteria:
Los Alamitos, California 90720-5402, United States
Boca Raton, Florida 33486, United States
Pittsburgh, Pennsylvania 15212-4756, United States
Colleyville, Texas 76034, United States
Fort Worth, Texas 76107, 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
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1121, Argentina
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires 1426, Argentina
Rosario, Santa Fe Province 2000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Salvador, Estado de Bahia 40150-150, Brazil
Vitacura Santiago, 7640881, Chile
Modena, Emilia-Romagna 41124, Italy
Kaunas, 50161, Lithuania
Mexico City, Mexico City 11850, Mexico
Colonia Centro, Yucatán 97000, Mexico
Mexico City, 03100, Mexico
Vila Nova de Gaia, Porto District 4434-502, Portugal
Ponte de Lima, Viana do Castelo District 4990-041, Portugal
Lisbon, 1649-035, Portugal
Korolev, Moscow 141060, Russia
Moscow, Moscow 115522, Russia
Saint Petersburg, Sankt-Peterburg 193015, Russia
Somerset West, Western Cape 7130, South Africa
Kharkiv, Kharkiv Oblast 61039, Ukraine
Vinnytsia, Vinnytsia Oblast 21029, Ukraine
Chernihiv, 14029, Ukraine
Lutsk, 43005, Ukraine
Stafford, Staffordshire ST16 3SR, United Kingdom
Metropolitan Borough of Wirral, CH49 5PE, United Kingdom