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)
NCT ID: NCT03671148
Last Updated: 2025-08-29
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
444 participants
INTERVENTIONAL
2019-03-07
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Risankizumab
Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.
Placebo
Placebo for risankizumab administered by subcutaneous (SC) injection
Risankizumab
Risankizumab administered by subcutaneous (SC) injection
Placebo
Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.
Placebo
Placebo for risankizumab administered by subcutaneous (SC) injection
Risankizumab
Risankizumab administered by subcutaneous (SC) injection
Interventions
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Placebo
Placebo for risankizumab administered by subcutaneous (SC) injection
Risankizumab
Risankizumab administered by subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 has a known hypersensitivity to risankizumab.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Pinnacle Research Group /ID# 167953
Anniston, Alabama, United States
St. Jude Heritage /ID# 166842
Fullerton, California, United States
Newport Huntington Medica /ID# 207423
Huntington Beach, California, United States
Arthritis & Osteo Medical Ctr /ID# 166541
La Palma, California, United States
East Bay Rheumatology Medical /ID# 166845
San Leandro, California, United States
Inland Rheum Clin Trials Inc. /ID# 166621
Upland, California, United States
Denver Arthritis Clinic /ID# 166442
Denver, Colorado, United States
New England Research Associates, LLC /ID# 166525
Bridgeport, Connecticut, United States
Yale University /ID# 166330
New Haven, Connecticut, United States
Arthritis & Rheumatic Disease Specialties /ID# 212582
Aventura, Florida, United States
SIMED Health, LLC /ID# 207457
Gainesville, Florida, United States
Sweet Hope Research Specialty Inc /ID# 168163
Hialeah, Florida, United States
Rheum Assoc of Central FL /ID# 201629
Orlando, Florida, United States
HMD Research LLC /ID# 208428
Orlando, Florida, United States
Millennium Research /ID# 201627
Ormond Beach, Florida, United States
Arthritis Center, Inc. /ID# 208116
Palm Harbor, Florida, United States
IRIS Research and Development, LLC /ID# 166351
Plantation, Florida, United States
BayCare Medical Group /ID# 201630
St. Petersburg, Florida, United States
West Broward Rheumatology Associates /ID# 201234
Tamarac, Florida, United States
University of South Florida /ID# 208467
Tampa, Florida, United States
ForCare Clinical Research /ID# 166375
Tampa, Florida, United States
Arthritis and Rheumatology /ID# 169438
Atlanta, Georgia, United States
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681
Skokie, Illinois, United States
Springfield Clinic /ID# 166345
Springfield, Illinois, United States
Ochsner Clinic Foundation /ID# 166622
Baton Rouge, Louisiana, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 166707
Monroe, Louisiana, United States
MMP Women's Health /ID# 169334
Portland, Maine, United States
Klein and Associates MD /ID# 166549
Hagerstown, Maryland, United States
Duplicate_The Center for Rheumatology & Bone Research /ID# 166448
Wheaton, Maryland, United States
Clinical Pharmacology Study Gr /ID# 166455
Worcester, Massachusetts, United States
St. Paul Rheumatology /ID# 166599
Eagan, Minnesota, United States
Clinvest Research LLC /ID# 166745
Springfield, Missouri, United States
Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389
St Louis, Missouri, United States
Glacier View Research Institute /ID# 169344
Kalispell, Montana, United States
Dartmouth-Hitchcock Medical Center /ID# 169443
Lebanon, New Hampshire, United States
Ocean Rheumatology, PA /ID# 166561
Toms River, New Jersey, United States
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658
Voorhees Township, New Jersey, United States
Paramount Medical Research Con /ID# 166334
Middleburg Heights, Ohio, United States
Health Research of Oklahoma /ID# 166408
Oklahoma City, Oklahoma, United States
Altoona Ctr Clinical Res /ID# 166691
Duncansville, Pennsylvania, United States
Clinical Research Ctr Reading /ID# 166354
Wyomissing, Pennsylvania, United States
West Tennessee Research Institute /ID# 166429
Jackson, Tennessee, United States
Nashville Arthritis and Rheumatology /ID# 208395
Nashville, Tennessee, United States
Amarillo Ctr for Clin Research /ID# 208340
Amarillo, Texas, United States
Tekton Research, Inc. /ID# 166493
Austin, Texas, United States
Precision Comprehensive Clinical Research Solutions /ID# 208156
Colleyville, Texas, United States
Rheumatology Clinic of Houston /ID# 166636
Houston, Texas, United States
West Texas Clinical Research /ID# 208155
Lubbock, Texas, United States
SW Rheumatology Res. LLC /ID# 166587
Mesquite, Texas, United States
Trinity Universal Research Associates, Inc /ID# 208387
Plano, Texas, United States
DM Clinical Research /ID# 208350
Tomball, Texas, United States
Kadlec Clinic Rheumatology /ID# 167667
Kennewick, Washington, United States
Arthritis Northwest, PLLC /ID# 169535
Spokane, Washington, United States
Rheumatology and Pulmonary Clinic /ID# 169341
Beckley, West Virginia, United States
Rheumatic Disease Center, LLP /ID# 166682
Glendale, Wisconsin, United States
Hospital General de Agudos J. M. Ramos Mejia /ID# 169152
Buenos Aires, Ciuadad Autonoma de Buenos Aires, Argentina
Hospital Italiano de Buenos Aires /ID# 208473
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, Argentina
DOM Centro de Reumatologia /ID# 208478
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151
Rosario, Santa Fe Province, Argentina
Instituto CAICI /ID# 169156
Rosario, Santa Fe Province, Argentina
Centro Medico Privado de Reumatologia /ID# 208342
San Miguel de Tucumán, Tucumán Province, Argentina
Cimer /Id# 169155
San Miguel de Tucumán, , Argentina
The Canberra Hospital /ID# 207591
Garran, Australian Capital Territory, Australia
Rheumatology Research Unit Sunshine Coast /ID# 207191
Maroochydore, Queensland, Australia
Griffith University /ID# 207504
Southport, Queensland, Australia
Emeritus Research /ID# 207195
Camberwell, Victoria, Australia
Monash Medical Centre /ID# 208033
Clayton, Victoria, Australia
UZ Gent /ID# 210037
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 208209
Leuven, Vlaams-Brabant, Belgium
ReumaClinic /ID# 208211
Genk, , Belgium
ZNA - Jan Palfijn /ID# 208210
Merksem, , Belgium
CIP - Centro Internacional de Pesquisa /ID# 169524
Goiânia, Goiás, Brazil
LMK Sevicos Medicos S/S /ID# 169541
Porto Alegre, Rio Grande do Sul, Brazil
Percuro Clinical Research, Ltd /ID# 169530
Victoria, British Columbia, Canada
CIADS Research Co Ltd /ID# 169526
Winnipeg, Manitoba, Canada
Dermatrials Research /ID# 208303
Hamilton, Ontario, Canada
K. Papp Clinical Research /ID# 169527
Waterloo, Ontario, Canada
Centre Rhumatologie de l'Est /ID# 208302
Rimouski, Quebec, Canada
Bispebjerg and Frederiksberg Hospital /ID# 168763
Frederiksberg, Capital Region, Denmark
Aarhus University Hospital /ID# 168762
Aarhus C, Central Jutland, Denmark
East Tallinn Central Hospital /ID# 208317
Tallinn, Harju, Estonia
MediTrials /ID# 207815
Tartu, Tartu, Estonia
North Estonia Medical Centre /ID# 208319
Tallinn, , Estonia
Ite Pihlajanlinna Kuopio /ID# 208316
Kuopio, , Finland
Turku University Hospital /ID# 208199
Turku, , Finland
Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159
Bordeaux, , France
CHRU Tours - Hopital Trousseau /ID# 209343
Chambray-lès-Tours, , France
Rheumazentrum Ruhrgebiet /ID# 207212
Herne, North Rhine-Westphalia, Germany
Immanuel Krankenhaus Berlin /ID# 207214
Buch, , Germany
Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494
Frankfurt, , Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493
Hamburg, , Germany
University General Hospital of Heraklion PA.G.N.I /ID# 206930
Heraklion, Crete, Greece
Naval Hospital of Athens /ID# 206928
Athens, , Greece
Olympion General Clinic SA /ID# 207047
Pátrai, , Greece
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248
Miskolc, Borsod-Abauj Zemplen county, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237
Szeged, Csongrád megye, Hungary
Vital-Medicina Kft. /ID# 208123
Veszprém, Veszprém megye, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054
Budapest, , Hungary
Sheba Medical Center /ID# 207468
Ramat Gan, Tel Aviv, Israel
Barzilai Medical Center /ID# 207471
Ashkelon, , Israel
Rambam Health Care Campus /ID# 208169
Haifa, , Israel
Meir Medical Center /ID# 207469
Kfar Saba, , Israel
Rabin Medical Center /ID# 207470
Petah Tikva, , Israel
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800
Modena, Emilia-Romagna, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268
Ancona, , Italy
Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264
Verona, , Italy
Antonius Ziekenhuis /ID# 208581
Sneek, Provincie Friesland, Netherlands
Universitair Medisch Centrum Groningen /ID# 168450
Groningen, , Netherlands
Medisch Centrum Leeuwarden /ID# 168449
Leeuwarden, , Netherlands
Waikato Hospital /ID# 214276
Hamilton, Waikato Region, New Zealand
Middlemore Clinical Trials /ID# 214293
Auckland, , New Zealand
CGM Research Trust /ID# 210596
Burwood Christchurch, , New Zealand
Malopolskie Centrum Kliniczne /ID# 208011
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Reuma Park w Warszawie /ID# 210956
Warsaw, Masovian Voivodeship, Poland
Osteo-Medic S.C. /ID# 208013
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012
Gdansk, Pomeranian Voivodeship, Poland
Centrum Kliniczno-Badawcze /ID# 208014
Elblag, Warmian-Masurian Voivodeship, Poland
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138
Ponte de Lima, Viana do Castelo District, Portugal
Instituto Português De Reumatologia /ID# 208140
Lisbon, , Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139
Lisbon, , Portugal
GCM Medical Group PSC - Hato Rey /ID# 208461
San Juan, , Puerto Rico
Changi General Hospital /ID# 208966
Singapore, , Singapore
Dr Jenny Potts /ID# 167628
Port Elizabeth, Eastern Cape, South Africa
Arthritis Clinical Research Trials /ID# 167611
Cape Town, Western Cape, South Africa
Winelands Medical Research Centre /ID# 167630
Stellenbosch, Western Cape, South Africa
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822
Sabadell, Barcelona, Spain
Hospital Unversitario Marques de Valdecilla /ID# 208541
Santander, Cantabria, Spain
Hospital Universitario A Coruna - CHUAC /ID# 207819
A Coruña, , Spain
Hospital Universitario 12 de Octubre /ID# 207820
Madrid, , Spain
Hospital Universitario y Politecnico La Fe /ID# 207823
Valencia, , Spain
Duplicate_Karolinska Univ Sjukhuset /ID# 208174
Solna, , Sweden
Uppsala University Hospital /ID# 169098
Uppsala, , Sweden
Duplicate_Vastmanlands Sjukhus /ID# 168620
Västerås, , Sweden
Orebro Universitetssjukhuset /ID# 169400
Örebro, Örebro County, Sweden
Duplicate_Barts Health NHS Trust /ID# 210794
London, London, City of, United Kingdom
Manchester University NHS Foundation Trust /ID# 207923
Manchester, , United Kingdom
Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536
Metropolitan Borough of Wirral, , United Kingdom
Torbay and South Devon Nhs Foundation Trust /Id# 207926
Torquay, , United Kingdom
Countries
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References
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Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Alperovich G, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022 Mar;81(3):351-358. doi: 10.1136/annrheumdis-2021-221048. Epub 2021 Nov 23.
Ostor A, Van den Bosch F, Papp K, Keiserman M, Blanco R, Crowley A, White D, Biljan A, Madihlaba T, Carter K, Liu F, Soliman AM, Ashley D, Chen M, Glotfelty L, Kivitz A. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 196-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Randomized Clinical Trials. Rheumatol Ther. 2025 Sep 30. doi: 10.1007/s40744-025-00793-3. Online ahead of print.
Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9.
Kwatra SG, Khattri S, Amin AZ, Ranza R, Kaplan B, Shi L, Padilla B, Soliman AM, McGonagle D. Enthesitis and Dactylitis Resolution with Risankizumab for Active Psoriatic Arthritis: Integrated Analysis of the Randomized KEEPsAKE 1 and 2 Trials. Dermatol Ther (Heidelb). 2024 Jun;14(6):1517-1530. doi: 10.1007/s13555-024-01174-4. Epub 2024 May 13.
Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Carter K, Stakias V, Lippe R, Drogaris L, Soliman AM, Chen MM, Padilla B, Kivitz A. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 2 Randomized Clinical Trial. Rheumatol Ther. 2024 Jun;11(3):633-648. doi: 10.1007/s40744-024-00657-2. Epub 2024 Mar 18.
Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco R, Aelion J, Lu W, Wang Z, Soliman AM, Eldred A, Padilla B, Kivitz A. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study. Rheumatology (Oxford). 2023 Jun 1;62(6):2122-2129. doi: 10.1093/rheumatology/keac605.
Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.
Ostor AJK, Soliman AM, Papp KA, Padilla B, Wang Z, Eldred A, de Vlam K, Kivitz A. Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. RMD Open. 2022 Jun;8(2):e002286. doi: 10.1136/rmdopen-2022-002286.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2023-505477-33
Identifier Type: OTHER
Identifier Source: secondary_id
M15-998
Identifier Type: -
Identifier Source: org_study_id
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