Psoriasis Clinical Trial
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)
Summary
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit.
Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline.
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 biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
Exclusion Criteria:
Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
Participant has a known hypersensitivity to risankizumab.
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There are 135 Locations for this study
Anniston Alabama, 36207, United States
Fullerton California, 92835, United States
Huntington Beach California, 92648, United States
La Palma California, 90623, United States
San Leandro California, 94578, United States
Upland California, 91786, United States
Denver Colorado, 80230, United States
Bridgeport Connecticut, 06606, United States
New Haven Connecticut, 06510, United States
Aventura Florida, 33180, United States
Gainesville Florida, 32607, United States
Hialeah Florida, 33016, United States
Orlando Florida, 32806, United States
Orlando Florida, 32819, United States
Ormond Beach Florida, 32174, United States
Palm Harbor Florida, 34684, United States
Plantation Florida, 33324, United States
Saint Petersburg Florida, 33705, United States
Tamarac Florida, 33321, United States
Tampa Florida, 33612, United States
Tampa Florida, 33613, United States
Atlanta Georgia, 30342, United States
Skokie Illinois, 60076, United States
Springfield Illinois, 62702, United States
Baton Rouge Louisiana, 70836, United States
Monroe Louisiana, 71203, United States
Portland Maine, 04102, United States
Hagerstown Maryland, 21740, United States
Wheaton Maryland, 20902, United States
Worcester Massachusetts, 01605, United States
Eagan Minnesota, 55121, United States
Saint Louis Missouri, 63119, United States
Springfield Missouri, 65810, United States
Kalispell Montana, 59901, United States
Lebanon New Hampshire, 03756, United States
Toms River New Jersey, 08755, United States
Voorhees New Jersey, 08043, United States
Middleburg Heights Ohio, 44130, United States
Oklahoma City Oklahoma, 73103, United States
Duncansville Pennsylvania, 16635, United States
Wyomissing Pennsylvania, 19610, United States
Jackson Tennessee, 38305, United States
Nashville Tennessee, 37203, United States
Amarillo Texas, 79124, United States
Austin Texas, 78745, United States
Colleyville Texas, 76034, United States
Houston Texas, 77065, United States
Lubbock Texas, 79410, United States
Mesquite Texas, 75150, United States
Plano Texas, 75024, United States
Tomball Texas, 77375, United States
Kennewick Washington, 99336, United States
Spokane Washington, 99204, United States
Beckley West Virginia, 25801, United States
Glendale Wisconsin, 53217, 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, 2000, Argentina
Rosario Santa Fe, 2000, Argentina
San Miguel de Tucuman Tucuman, 4000, Argentina
San Miguel de Tucuman , 4000, Argentina
Garran Australian Capital Territory, 2605, Australia
Maroochydore Queensland, 4558, Australia
Southport Queensland, 4222, Australia
Camberwell Victoria, 3124, Australia
Clayton Victoria, 3168, Australia
Gent Oost-Vlaanderen, 9000, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Genk , 3600, Belgium
Merksem , 2170, Belgium
Goiânia Goias, 74110, Brazil
Porto Alegre Rio Grande Do Sul, 90480, Brazil
Victoria British Columbia, V8V 3, Canada
Winnipeg Manitoba, R3N 0, Canada
Hamilton Ontario, L8N 1, Canada
Waterloo Ontario, N2J 1, Canada
Rimouski Quebec, G5L 8, Canada
Frederiksberg Hovedstaden, 2000, Denmark
Aarhus C Midtjylland, 8000, Denmark
Tallinn Harjumaa, 10138, Estonia
Tartu Tartumaa, 50708, Estonia
Tallinn , 13419, Estonia
Kuopio , 70100, Finland
Turku , 20520, Finland
Bordeaux , 33076, France
Chambray Les Tours , 37170, France
Herne Nordrhein-Westfalen, 44649, Germany
Berlin-buch , 13125, Germany
Frankfurt , 60590, Germany
Hamburg , 20095, Germany
Heraklion Kriti, 71307, Greece
Athens , 11521, Greece
Patras , 26443, Greece
Miskolc Borsod-Abauj-Zemplen, 3529, Hungary
Szeged Csongrad, 6725, Hungary
Veszprém Veszprem, 8200, Hungary
Budapest , 1023, Hungary
Ramat Gan Tel-Aviv, 52394, Israel
Ashkelon , 78306, Israel
Haifa , 31096, Israel
Kfar Saba , 44281, Israel
Petakh Tikva , 49414, Israel
Modena Emilia-Romagna, 41124, Italy
Ancona , 60126, Italy
Verona , 37134, Italy
Sneek Fryslan, 8601 , Netherlands
Groningen , 9713 , Netherlands
Leeuwarden , 8934 , Netherlands
Hamilton Waikato, 3204, New Zealand
Auckland , 2025, New Zealand
Burwood Christchurch , 8083, New Zealand
Krakow Malopolskie, 30-14, Poland
Warsaw Mazowieckie, 02-69, Poland
Bialystok Podlaskie, 15-35, Poland
Gdansk Pomorskie, 80-54, Poland
Elblag Warminsko-mazurskie, 82-30, Poland
Ponte de Lima Viana Do Castelo, 4990-, Portugal
Lisboa , 1050-, Portugal
Lisboa , 1649-, Portugal
San Juan , 00917, Puerto Rico
Singapore , 52988, Singapore
Port Elizabeth Eastern Cape, 6405, South Africa
Cape Town Western Cape, 7405, South Africa
Stellenbosch Western Cape, 7600, South Africa
Sabadell Barcelona, 08208, Spain
Santander Cantabria, 39008, Spain
A Coruna , 15006, Spain
Madrid , 28041, Spain
Valencia , 46026, Spain
Orebro Orebro Lan, 701 8, Sweden
Solna , 171 6, Sweden
Uppsala , 75185, Sweden
Vasteras , 723 3, Sweden
London London, City Of, E11 1, United Kingdom
Manchester , M13 9, United Kingdom
Torquay , TQ2 7, United Kingdom
Wirral , CH49 , United Kingdom
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