Psoriasis Clinical Trial
A Study Comparing Risankizumab to Placebo in Participants 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
Summary
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).
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 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.
Eligibility Criteria
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:
≥ 1 erosion on radiograph as determined by central imaging review or;
High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.
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.
Participant has previous treatment with biologic agent.
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There are 239 Locations for this study
Anniston Alabama, 36207, United States
Peoria Arizona, 85381, United States
Phoenix Arizona, 85032, United States
Tucson Arizona, 85704, United States
Tucson Arizona, 85723, United States
Jonesboro Arkansas, 72401, United States
Los Alamitos California, 90720, United States
San Diego California, 92128, United States
Upland California, 91786, United States
Whittier California, 90606, United States
Bridgeport Connecticut, 06606, United States
Danbury Connecticut, 06810, United States
Hamden Connecticut, 06518, United States
Aventura Florida, 33180, United States
Boca Raton Florida, 33486, United States
Gainesville Florida, 32607, United States
Hialeah Florida, 33016, United States
Jacksonville Florida, 32216, United States
Orlando Florida, 32806, United States
Orlando Florida, 32819, United States
Plantation Florida, 33324, United States
Tampa Florida, 33613, United States
Atlanta Georgia, 30342, United States
Oak Brook Illinois, 60523, United States
Rockford Illinois, 61114, United States
Springfield Illinois, 62702, United States
Hagerstown Maryland, 21740, United States
Wheaton Maryland, 20902, United States
Worcester Massachusetts, 01605, United States
Lansing Michigan, 48910, United States
Lansing Michigan, 48910, United States
Eagan Minnesota, 55121, United States
Kalispell Montana, 59901, United States
Lincoln Nebraska, 68516, United States
Albany New York, 12203, United States
Brooklyn New York, 11201, United States
Charlotte North Carolina, 28204, United States
Greensboro North Carolina, 27408, United States
New Bern North Carolina, 28562, United States
Blue Ash Ohio, 45242, United States
Marietta Ohio, 45750, United States
Middleburg Heights Ohio, 44130, United States
Springboro Ohio, 45066, United States
Oklahoma City Oklahoma, 73103, United States
Duncansville Pennsylvania, 16635, United States
Pittsburgh Pennsylvania, 15212, United States
Wyomissing Pennsylvania, 19610, United States
Nashville Tennessee, 37203, United States
Amarillo Texas, 79124, United States
Colleyville Texas, 76034, United States
Dallas Texas, 75216, United States
Fort Worth Texas, 76107, United States
The Woodlands Texas, 77382, United States
Tomball Texas, 77375, United States
Kennewick Washington, 99336, United States
Beckley West Virginia, 25801, United States
Franklin Wisconsin, 53132, United States
Manitowoc Wisconsin, 54220, United States
Onalaska Wisconsin, 54650, United States
La Plata Buenos Aires, 1902, Argentina
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, 2000, Argentina
Rosario Santa Fe, 2000, Argentina
San Miguel de Tucuman Tucuman, 4000, Argentina
Buenos Aires , 2201, Argentina
Cordoba , 5016, Argentina
San Miguel de Tucuman , 4000, Argentina
Garran Australian Capital Territory, 2605, Australia
Herston Queensland, 4029, Australia
Maroochydore Queensland, 4558, Australia
Southport Queensland, 4222, Australia
Bedford, Park South Australia, 5042, Australia
Camberwell Victoria, 3124, Australia
Clayton Victoria, 3168, Australia
Ghent Oost-Vlaanderen, 9000, Belgium
Genk , 3600, Belgium
Merksem , 2170, Belgium
Banja Luka Republika Srpska, 78000, Bosnia and Herzegovina
Banja Luka Republika Srpska, 78000, Bosnia and Herzegovina
Banja Luka Republika Srpska, 78000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Salvador Bahia, 40150, Brazil
Juiz de Fora Minas Gerais, 36010, Brazil
Curitiba Parana, 80440, Brazil
Porto Alegre Rio Grande Do Sul, 90480, Brazil
Sao Paulo , 01228, Brazil
Pleven , 5800, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1505, Bulgaria
Sofia , 1606, Bulgaria
Victoria British Columbia, V8V 3, Canada
Winnipeg Manitoba, R3A 1, Canada
Winnipeg Manitoba, R3N 0, Canada
Peterborough Ontario, K9J 5, Canada
Waterloo Ontario, N2J 1, Canada
Sainte-foy Quebec, G1V 3, Canada
Saskatoon Saskatchewan, S7K 3, Canada
Providencia , 75005, Chile
Santiago , 84203, Chile
Vitacura Santiago , 76408, Chile
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Osijek Osjecko-baranjska Zupanija, 31000, Croatia
Rijeka Primorsko-goranska Zupanija, 51000, Croatia
Split Splitsko-dalmatinska Zupanija, 21000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Brno , 615 0, Czechia
Praha , 130 0, Czechia
Praha , 140 0, Czechia
Praha , 148 0, Czechia
Uherske Hradiste , 686 0, Czechia
Frederiksberg Hovedstaden, 2000, Denmark
Aarhus C Midtjylland, 8000, Denmark
Mustamäe Linnaosa Harjumaa, 13419, Estonia
Tallinn Harjumaa, 10117, Estonia
Tartu Tartumaa, 50708, Estonia
Helsinki Uusimaa, 00290, Finland
Kuopio , 70100, Finland
Turku , 20520, Finland
Herne Nordrhein-Westfalen, 44649, Germany
Berlin-buch , 13125, Germany
Frankfurt , 60590, Germany
Hamburg , 20095, Germany
Athens Attiki, 16673, Greece
Heraklion Kriti, 71500, Greece
Efkarpia (Thessalonikis) Thessaloniki, 56429, Greece
Athens , 11521, Greece
Patras , 26443, Greece
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
Catania , 95124, Italy
Rome , 00133, Italy
Verona , 37134, Italy
Seoul Seoul Teugbyeolsi, 04763, Korea, Republic of
Seoul Seoul Teugbyeolsi, 05030, Korea, Republic of
Daegu , 41944, Korea, Republic of
Adazi , LV-21, Latvia
Liepaja , LV-34, Latvia
Riga , 1002, Latvia
Riga , LV-10, Latvia
Riga , LV-10, Latvia
Kaunas , 50128, Lithuania
Kaunas , 50161, Lithuania
Klaipeda , 92288, Lithuania
Siauliai , 76231, Lithuania
Seremban Negeri Sembilan, 70300, Malaysia
Ipoh Perak, 30450, Malaysia
Batu Caves Selangor, 68100, Malaysia
Kuala Lumpur , 59100, Malaysia
Mexico City Ciudad De Mexico, 11850, Mexico
Guadalajara Jalisco, 44160, Mexico
Monterrey Nuevo Leon, 64718, Mexico
Colonia Centro Yucatan, 97000, Mexico
Ciudad de Mexico , 03100, Mexico
Mexico City , 03100, Mexico
Sneek Fryslan, 8601 , Netherlands
Groningen , 9713 , Netherlands
Leeuwarden , 8934 , Netherlands
Papatoetoe Auckland, 2025, New Zealand
Hamilton Waikato, 3240, New Zealand
Burwood , 8083, New Zealand
Bydgoszcz Kujawsko-pomorskie, 85-60, Poland
Torun Kujawsko-pomorskie, 87-10, Poland
Krakow Malopolskie, 30-14, Poland
Grodzisk Mazowiecki Mazowieckie, 05-82, Poland
Warsaw Mazowieckie, 02-69, Poland
Bialystok Podlaskie, 15-35, Poland
Bialystok Podlaskie, 15-87, Poland
Elblag Warminsko-mazurskie, 82-30, Poland
Olsztyn Warminsko-mazurskie, 10-11, Poland
Vila Nova De Gaia Porto, 4434-, Portugal
Ponte de Lima Viana Do Castelo, 4990-, Portugal
Aveiro , 3810-, Portugal
Braga , 4710-, Portugal
Lisboa , 1050-, Portugal
Lisboa , 1649-, Portugal
San Juan , 00918, Puerto Rico
Timisoara Timis, 30076, Romania
Bucuresti , 01117, Romania
Cluj-Napoca , 40000, Romania
Iasi , 70066, Romania
Korolev Moskva, 14106, Russian Federation
Moscow Moskva, 11552, Russian Federation
Novosibirsk Novosibirskaya Oblast, 63009, Russian Federation
St. Petersburg Sankt-Peterburg, 19301, Russian Federation
Kazan Tatarstan, Respublika, 42001, Russian Federation
Moscow , 11799, Russian Federation
Perm , 61499, Russian Federation
Ulyanovsk , 43201, Russian Federation
Belgrade Beograd, 11000, Serbia
Belgrade Beograd, 11000, Serbia
Belgrade Beograd, 11000, Serbia
Belgrade Beograd, 11000, Serbia
Belgrade Beograd, 11000, Serbia
Novi Sad Vojvodina, 21000, Serbia
Novi Sad Vojvodina, 21000, Serbia
Singapore , 11907, Singapore
Singapore , 16960, Singapore
Singapore , 52988, Singapore
Biely Kostol , 919 3, Slovakia
Martin , 036 0, Slovakia
Nove Mesto nad Vahom , 915 0, Slovakia
Piestany , 921 0, Slovakia
Poprad , 058 0, Slovakia
Port Elizabeth Eastern Cape, 6405, South Africa
Pretoria Gauteng, 0001, South Africa
Pretoria Gauteng, 0002, South Africa
Cape Town Western Cape, 7405, South Africa
Somerset West Western Cape, 7130, South Africa
Stellenbosch Western Cape, 7600, South Africa
Badalona Barcelona, 08916, Spain
Sabadell Barcelona, 08208, Spain
A Coruna , 15006, Spain
Almeria , 04009, Spain
Barcelona , 08003, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Valencia , 46026, Spain
Orebro Orebro Lan, 701 8, Sweden
Malmo Skane Lan, 214 2, Sweden
Falun , 791 3, Sweden
Solna , 171 6, Sweden
Uppsala , 75185, Sweden
Vasteras , 723 3, Sweden
Chia-Yi , 62247, Taiwan
Taichung , 40201, Taiwan
Taoyuan City , 333, Taiwan
Kharkiv Kharkivska Oblast, 61039, Ukraine
Vinnytsia Vinnytska Oblast, 21029, Ukraine
Cherkasy , 18009, Ukraine
Chernihiv , 14029, Ukraine
Kharkiv , 61029, Ukraine
Khmelnytskyi , 29000, Ukraine
Kryvyi Rih , 50056, Ukraine
Kyiv , 02091, Ukraine
Lutsk , 43005, Ukraine
Lviv , 79011, Ukraine
Poltava , 36011, Ukraine
Zaporizhzhia , 69035, Ukraine
London London, City Of, E11 1, United Kingdom
Glasgow Scotland, G12 0, United Kingdom
Stafford Staffordshire, ST16 , United Kingdom
Manchester , M13 9, United Kingdom
Portsmouth , PO6 3, United Kingdom
Torquay , TQ2 7, United Kingdom
Wirral , CH49 , United Kingdom
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