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
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)
2 other identifiers
interventional
964
37 countries
246
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2019
Longer than P75 for phase_3
246 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2020
CompletedResults Posted
Study results publicly available
February 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2026
ExpectedAugust 5, 2025
August 1, 2025
1.5 years
September 12, 2018
January 24, 2022
August 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Baseline and Week 24
Secondary Outcomes (13)
Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
Baseline and Week 24
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
Baseline and Week 24
Percentage of Participants With an ACR20 Response at Week 16
Baseline and Week 16
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Week 24
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24
Baseline and Week 24
- +8 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants 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.
Risankizumab
EXPERIMENTALParticipants 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.
Interventions
Risankizumab administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (256)
Pinnacle Research Group /ID# 167955
Anniston, Alabama, 36207, United States
Sun Valley Arthritis Center Ltd. /ID# 200270
Peoria, Arizona, 85381, United States
AZ Arthritis and Rheumotology Research, PLLC /ID# 209873
Phoenix, Arizona, 85032-9306, United States
Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875
Tucson, Arizona, 85704, United States
Southern Arizona VA Health Care System /ID# 209247
Tucson, Arizona, 85723, United States
Arthritis and Rheumatism Associates /ID# 209882
Jonesboro, Arkansas, 72401-6251, United States
Valerius Medical Group & Research Center /ID# 207428
Los Alamitos, California, 90720-5402, United States
Rheumatology Center of San Diego /ID# 201642
San Diego, California, 92128-2549, United States
Inland Rheum Clin Trials Inc. /ID# 201641
Upland, California, 91786, United States
Medvin Clinical Research /ID# 211127
Whittier, California, 90606, United States
New England Research Associates, LLC /ID# 207237
Bridgeport, Connecticut, 06606-1827, United States
Danbury Clinical Research, LLC /ID# 209517
Danbury, Connecticut, 06810, United States
Arthritis & Osteoporosis Center /ID# 207236
Hamden, Connecticut, 06518, United States
Arthritis & Rheumatic Disease Specialties /ID# 210802
Aventura, Florida, 33180, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099
Boca Raton, Florida, 33486, United States
SIMED Health, LLC /ID# 207461
Gainesville, Florida, 32607-2817, United States
Sweet Hope Research Specialty Inc /ID# 209393
Hialeah, Florida, 33016-1897, United States
Jacksonville Center for Clinical Research /ID# 209876
Jacksonville, Florida, 32216, United States
Rheum Assoc of Central FL /ID# 201622
Orlando, Florida, 32806, United States
HMD Research LLC /ID# 208427
Orlando, Florida, 32819, United States
IRIS Research and Development, LLC /ID# 208955
Plantation, Florida, 33324, United States
ForCare Clinical Research /ID# 168034
Tampa, Florida, 33613-1244, United States
Arthritis and Rheumatology /ID# 168046
Atlanta, Georgia, 30342, United States
Affinity Clinical Research /ID# 210816
Oak Brook, Illinois, 60523-1245, United States
OrthoIllinois /ID# 205300
Rockford, Illinois, 61114-4937, United States
Springfield Clinic /ID# 200244
Springfield, Illinois, 62702-3749, United States
Klein and Associates MD /ID# 169483
Hagerstown, Maryland, 21740, United States
The Center for Rheumatology and Bone Research /ID# 168017
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Gr /ID# 168019
Worcester, Massachusetts, 01605, United States
Advanced Rheumatology, PC /ID# 168042
Lansing, Michigan, 48910, United States
June DO, PC /ID# 208915
Lansing, Michigan, 48910, United States
St. Paul Rheumatology /ID# 208471
Eagan, Minnesota, 55121, United States
Logan Health Research /ID# 213707
Kalispell, Montana, 59901, United States
Physician Research Collaboration, LLC /ID# 208670
Lincoln, Nebraska, 68516, United States
Center for Rheumatology LLP /ID# 207313
Albany, New York, 12203-3710, United States
NYU Langone Ambulatory Care Brooklyn Heights /ID# 207310
Brooklyn, New York, 11201, United States
Joint & Muscle Research Instit /ID# 208620
Charlotte, North Carolina, 28204, United States
Medication Management, LLC /ID# 211734
Greensboro, North Carolina, 27408, United States
Coastal Carolina Health Care /ID# 208619
New Bern, North Carolina, 28562, United States
Velocity Clinical Research /ID# 200452
Blue Ash, Ohio, 45242-3763, United States
Marietta Memorial Hospital /ID# 210179
Marietta, Ohio, 45750-1635, United States
Paramount Medical Research Con /ID# 201583
Middleburg Heights, Ohio, 44130, United States
STAT Research, Inc. /ID# 213805
Springboro, Ohio, 45066, United States
Health Research of Oklahoma /ID# 168027
Oklahoma City, Oklahoma, 73103-2400, United States
Altoona Ctr Clinical Res /ID# 168037
Duncansville, Pennsylvania, 16635, United States
Allegheny Health Network Research Institute /ID# 210349
Pittsburgh, Pennsylvania, 15212-4756, United States
Clinical Research Ctr Reading /ID# 168070
Wyomissing, Pennsylvania, 19610, United States
Nashville Arthritis and Rheumatology /ID# 168069
Nashville, Tennessee, 37203, United States
Amarillo Ctr for Clin Research /ID# 208347
Amarillo, Texas, 79124, United States
Precision Comprehensive Clinical Research Solutions /ID# 208386
Colleyville, Texas, 76034, United States
Dallas VA Medical Center /ID# 208389
Dallas, Texas, 75216, United States
Precision Comprehensive Clinical Research Solutions /ID# 210597
Fort Worth, Texas, 76107, United States
Advanced Rheumatology of Houston /ID# 208354
The Woodlands, Texas, 77382, United States
DM Clinical Research /ID# 208351
Tomball, Texas, 77375, United States
Kadlec Clinic Rheumatology /ID# 207969
Kennewick, Washington, 99336, United States
Rheumatology and Pulmonary Clinic /ID# 200446
Beckley, West Virginia, 25801, United States
Aurora Rheumatology and Immunotherapy Center /ID# 168066
Franklin, Wisconsin, 53132, United States
Holy Family Memorial, Inc. /ID# 209387
Manitowoc, Wisconsin, 54220, United States
Gundersen Clinic, Ltd /ID# 209459
Onalaska, Wisconsin, 54650, United States
Framingham Centro Medico /ID# 210409
La Plata, Buenos Aires, 1902, Argentina
Hospital General de Agudos J. M. Ramos Mejia /ID# 169164
Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1221, Argentina
Hospital Italiano de Buenos Aires /ID# 208474
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1199, Argentina
DOM Centro de Reumatologia /ID# 208479
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1111, Argentina
Fundacion CIDEA /ID# 210494
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1121, Argentina
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 211622
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1426, Argentina
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169163
Rosario, Santa Fe Province, 2000, Argentina
Instituto CAICI /ID# 169168
Rosario, Santa Fe Province, 2000, Argentina
Centro Medico Privado de Reumatologia /ID# 208343
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Duplicate_Inst de Rehab Psicofisica /ID# 214681
Buenos Aires, 2201, Argentina
Duplicate_Hospital Privado Univesitario /ID# 211623
Córdoba, 5016, Argentina
Cimer /Id# 169167
San Miguel de Tucumán, 4000, Argentina
The Canberra Hospital /ID# 207592
Garran, Australian Capital Territory, 2605, Australia
Royal Brisbane and Women's Hospital /ID# 212785
Herston, Queensland, 4029, Australia
Rheumatology Research Unit Sunshine Coast /ID# 207200
Maroochydore, Queensland, 4558, Australia
Griffith University /ID# 207505
Southport, Queensland, 4222, Australia
Flinders Medical Centre /ID# 210562
Bedford Park, South Australia, 5042, Australia
Emeritus Research /ID# 207202
Camberwell, Victoria, 3124, Australia
Monash Medical Centre /ID# 208034
Clayton, Victoria, 3168, Australia
Duplicate_UZ Ghent /ID# 210036
Ghent, Oost-Vlaanderen, 9000, Belgium
ReumaClinic /ID# 208213
Genk, 3600, Belgium
ZNA - Jan Palfijn /ID# 208212
Merksem, 2170, Belgium
University Clinical Centre of the Republic of Srpska /ID# 208268
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 208269
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 210047
Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina
Clinical Center University of Sarajevo /ID# 208272
Sarajevo, 71000, Bosnia and Herzegovina
SER - Serviços Especializados em Reumatologia /ID# 207489
Salvador, Estado de Bahia, 40150-150, Brazil
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 207496
Juiz de Fora, Minas Gerais, 36010-570, Brazil
EDUMED Educacao em Saude S/S L /ID# 207488
Curitiba, Paraná, 80440-080, Brazil
LMK Sevicos Medicos S/S /ID# 207491
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
CPCLIN - Centro de Pesquisas Clínicas /ID# 207493
São Paulo, 01228-200, Brazil
Medical center Medconsult /ID# 211399
Pleven, 5800, Bulgaria
Medical center Excelsior /ID# 167741
Sofia, 1407, Bulgaria
Diagnostic consultative center 17 Sofia /ID# 210506
Sofia, 1505, Bulgaria
Military Medical Academy Multiprofile Hospital /ID# 210829
Sofia, 1606, Bulgaria
Percuro Clinical Research, Ltd /ID# 169601
Victoria, British Columbia, V8V 3M9, Canada
Manitoba Clinic /ID# 206819
Winnipeg, Manitoba, R3A 1M3, Canada
CIADS Research Co Ltd /ID# 169600
Winnipeg, Manitoba, R3N 0K6, Canada
SKIN Centre for Dermatology /ID# 169604
Peterborough, Ontario, K9J 5K2, Canada
K. Papp Clinical Research /ID# 169603
Waterloo, Ontario, N2J 1C4, Canada
Groupe de Recherche en Maladies Osseuses Inc /ID# 169598
Sainte-Foy, Quebec, G1V 3M7, Canada
Dr. Latha Naik /ID# 212188
Saskatoon, Saskatchewan, S7K 3H3, Canada
CTR Estudios Clinicos /ID# 208166
Providencia, 7500571, Chile
Centro Internacional de Estudios Clinicos /ID# 209908
Santiago, 8420383, Chile
Clinica Dermacross S.A /ID# 208163
Vitacura Santiago, 7640881, Chile
Poliklinika Repromed /ID# 208628
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika Solmed /ID# 210965
Zagreb, City of Zagreb, 10000, Croatia
UHC Osijek /ID# 208623
Osijek, County of Osijek-Baranja, 31000, Croatia
Klinicki bolnicki centar Rijeka /ID# 208621
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
Klinicki bolnicki centar Split /ID# 208626
Split, Split-Dalmatia County, 21000, Croatia
Medical Center Kuna-Peric /ID# 208047
Zagreb, 10000, Croatia
Poliklinika Bonifarm /ID# 208750
Zagreb, 10000, Croatia
Revmacentrum MUDr. Mostera, s.r.o. /ID# 209025
Brno, 615 00, Czechia
PV MEDICAL Services s.r.o. /ID# 210222
Prague, 130 00, Czechia
MUDr. Zuzana Stejfova - revmatologicka ambulance /ID# 209027
Prague, 140 00, Czechia
Affidea Praha s.r.o. /ID# 210223
Prague, 148 00, Czechia
MEDICAL PLUS, s.r.o. /ID# 210439
Uherské Hradiště, 686 01, Czechia
Bispebjerg and Frederiksberg Hospital /ID# 207576
Frederiksberg, Capital Region, 2000, Denmark
Aarhus University Hospital /ID# 168761
Aarhus C, Central Jutland, 8000, Denmark
North Estonia Medical Centre /ID# 208325
Mustamäe, Harju, 13419, Estonia
Innomedica /ID# 211416
Tallinn, Harju, 10117, Estonia
MediTrials /ID# 207816
Tartu, Tartu, 50708, Estonia
Helsinki University Hospital /ID# 207724
Helsinki, Uusimaa, 00290, Finland
Ite Pihlajanlinna Kuopio /ID# 208322
Kuopio, 70100, Finland
Turku University Hospital /ID# 207726
Turku, 20520, Finland
Rheumazentrum Ruhrgebiet /ID# 207216
Herne, North Rhine-Westphalia, 44649, Germany
Immanuel Krankenhaus Berlin /ID# 207218
Buch, 13125, Germany
Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209483
Frankfurt, 60590, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209484
Hamburg, 20095, Germany
General Hospital Asklepieio Voulas /ID# 212956
Athens, Attica, 16673, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 206839
Heraklion, Crete, 71500, Greece
424 General MILITARY Hospital /ID# 210974
Efkarpia (Thessalonikis), Thessaloniki, 56429, Greece
Naval Hospital of Athens /ID# 206838
Athens, 11521, Greece
Olympion General Clinic SA /ID# 207048
Pátrai, 26443, Greece
Sheba Medical Center /ID# 207474
Ramat Gan, Tel Aviv, 5239424, Israel
Barzilai Medical Center /ID# 207476
Ashkelon, 7830604, Israel
Rambam Health Care Campus /ID# 208170
Haifa, 3109601, Israel
Meir Medical Center /ID# 207473
Kfar Saba, 4428164, Israel
Rabin Medical Center /ID# 207475
Petah Tikva, 4941492, Israel
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207799
Modena, Emilia-Romagna, 41124, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207269
Ancona, 60126, Italy
A.O.U. Policlinico G. Rodolico S.Marco - Presidio San Marco /ID# 207795
Catania, 95124, Italy
Duplicate_Policlinico Univ Tor Vergata /ID# 207271
Rome, 00133, Italy
Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207265
Verona, 37134, Italy
M & M Centrs LTD /ID# 208733
Ādaži, LV-2164, Latvia
D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 207224
Liepāja, LV-3401, Latvia
Pauls Stradins Clinical University Hospital /ID# 207220
Riga, 1002, Latvia
Clinic ORTO /ID# 216218
Riga, LV-1005, Latvia
Riga East Clinical University Hospital /ID# 207223
Riga, LV-1079, Latvia
VAKK Dr. Kilda's Clinic /ID# 207330
Kaunas, 50128, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207331
Kaunas, 50161, Lithuania
Klaipeda University Hospital /ID# 207329
Klaipėda, 92288, Lithuania
Republican Siauliai hospital /ID# 207328
Šiauliai, 76231, Lithuania
Hospital Tuanku Jaafar /ID# 207919
Seremban, Negeri Sembilan, 70300, Malaysia
Hospital Raja Permaisuri Bainun /ID# 207920
Ipoh, Perak, 30450, Malaysia
Hospital Selayang /ID# 208938
Batu Caves, Selangor, 68100, Malaysia
University Malaya Med Ctr /ID# 208937
Kuala Lumpur, 59100, Malaysia
Centro Integral en Reumatologia S.A de C.V /ID# 208346
Guadalajara, Jalisco, 44160, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 208331
Mexico City, Mexico City, 11850, Mexico
Eukarya PharmaSite, SC /ID# 208431
Monterrey, Nuevo León, 64718, Mexico
Centro Peninsular de Investigación Clínica SCP /ID# 208345
Colonia Centro, Yucatán, 97000, Mexico
Hospital General Regional No. 1 Dr. Carlos Mac Gregor Sánchez Navarro /ID# 210835
Mexico City, 03100, Mexico
RM Pharma Specialists S.A de C.V /ID# 208330
Mexico City, 03100, Mexico
Antonius Ziekenhuis /ID# 208587
Sneek, Provincie Friesland, 8601 ZK, Netherlands
Universitair Medisch Centrum Groningen /ID# 208580
Groningen, 9713 GZ, Netherlands
Medisch Centrum Leeuwarden /ID# 168453
Leeuwarden, 8934 AD, Netherlands
Middlemore Clinical Trials /ID# 213256
Papatoetoe, Auckland, 2025, New Zealand
Waikato Hospital /ID# 213257
Hamilton, Waikato Region, 3240, New Zealand
CGM Research Trust /ID# 210498
Burwood, 8083, New Zealand
Spolka Lekarzy INTERCOR /ID# 210191
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605, Poland
Nasz Lekarz Przychodnie Medyczne /ID# 216176
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Malopolskie Centrum Kliniczne /ID# 208007
Krakow, Lesser Poland Voivodeship, 30-149, Poland
McBk Sc /Id# 209132
Grodzisk Mazowiecki, Masovian Voivodeship, 05-825, Poland
Centrum Medyczne Reuma Park w Warszawie /ID# 210352
Warsaw, Masovian Voivodeship, 02-691, Poland
Osteo-Medic S.C. /ID# 208008
Bialystok, Podlaskie Voivodeship, 15-351, Poland
ClinicMed Daniluk, Nowak Sp.j. /ID# 210824
Bialystok, Podlaskie Voivodeship, 15-879, Poland
Centrum Kliniczno-Badawcze /ID# 208010
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
ETYKA-Osrodek Badan Klinicznych /ID# 216241
Olsztyn, Warmian-Masurian Voivodeship, 10-117, Poland
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208145
Vila Nova de Gaia, Porto District, 4434-502, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208147
Ponte de Lima, Viana do Castelo District, 4990-041, Portugal
Centro Hospitalar do Baixo Vouga /ID# 215979
Aveiro, 3810-164, Portugal
CCA Braga - Hospital de Braga /ID# 208146
Braga, 4710-243, Portugal
Instituto Português De Reumatologia /ID# 208149
Lisbon, 1050-034, Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208148
Lisbon, 1649-035, Portugal
Mindful Medical Research /ID# 211129
San Juan, 00918-3756, Puerto Rico
Cabinet Medical Dr Triff Carina /Id# 207528
Timișoara, Timiș County, 300766, Romania
Spitalul Clinic Sf. Maria /ID# 210054
Bucharest, 011172, Romania
Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 207340
Cluj-Napoca, 400006, Romania
Spitalul Clinic de Recuperare Iasi /ID# 207371
Iași, 700661, Romania
LLC Family Outpatient Clinic № /ID# 169510
Korolev, Moscow, 141060, Russia
Research Institute of Rheumatology named after V.A. Nasonova /ID# 207643
Moscow, Moscow, 115522, Russia
LLC Medical Center /ID# 169516
Novosibirsk, Novosibirsk Oblast, 630099, Russia
Nort-Western State Medical University n.a. Mechnikov /ID# 207641
Saint Petersburg, Sankt-Peterburg, 193015, Russia
Kazan State Medical University /ID# 169511
Kazan', Tatarstan, Respublika, 420012, Russia
Federal Center for Brain and Neurotechnology /ID# 207646
Moscow, 117997, Russia
Perm Regional Clinical Hospital /ID# 207642
Perm, 614990, Russia
Ulyanovsk Regional Clinical Hospital /ID# 169515
Ulyanovsk, 432017, Russia
Institute for Rheumatology /ID# 168194
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 168197
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 168198
Belgrade, Beograd, 11000, Serbia
Institute for Rheumatology /ID# 168199
Belgrade, Beograd, 11000, Serbia
Military Medical Academy /ID# 168218
Belgrade, Beograd, 11000, Serbia
Special Hospital for Rheuma /ID# 168255
Novi Sad, Vojvodina, 21000, Serbia
Special Hospital for Rheuma /ID# 210284
Novi Sad, Vojvodina, 21000, Serbia
National University Hospital /ID# 208599
Singapore, 119074, Singapore
Singapore General Hospital /ID# 207917
Singapore, 169608, Singapore
Changi General Hospital /ID# 208965
Singapore, 529889, Singapore
REUMA-GLOBAL, s.r.o. /ID# 208017
Biely Kostol, 919 34, Slovakia
MEDMAN s.r.o. /ID# 208018
Martin, 036 01, Slovakia
Reum.hapi s.r.o. /ID# 208016
Nové Mesto nad Váhom, 915 01, Slovakia
Thermium s.r.o. /ID# 208015
Piešťany, 921 01, Slovakia
REUMAMED POPRAD s.r.o. /ID# 208407
Poprad, 058 01, Slovakia
Dr Jenny Potts /ID# 168691
Port Elizabeth, Eastern Cape, 6405, South Africa
University of Pretoria /ID# 167621
Pretoria, Gauteng, 0001, South Africa
Dr Elsa van Duuren /ID# 207577
Pretoria, Gauteng, 0002, South Africa
Arthritis Clinical Research Trials /ID# 167625
Cape Town, Western Cape, 7405, South Africa
Synexus Helderberg Clinical Research Centre /ID# 210891
Somerset West, Western Cape, 7130, South Africa
Winelands Medical Research Centre /ID# 167629
Stellenbosch, Western Cape, 7600, South Africa
Hanyang University Seoul Hospital /ID# 209263
Seoul, Seoul Teugbyeolsi, 04763, South Korea
Duplicate_Konkuk University Medical Ctr /ID# 207509
Seoul, Seoul Teugbyeolsi, 05030, South Korea
Kyungpook National Univ Hosp /ID# 207408
Daegu, 41944, South Korea
Hospital Universitario Germans Trias i Pujol /ID# 208543
Badalona, Barcelona, 08916, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207830
Sabadell, Barcelona, 08208, Spain
Hospital Universitario A Coruna - CHUAC /ID# 207826
A Coruña, 15006, Spain
Hospital Universitario Torrecardenas /ID# 212716
Almería, 04009, Spain
Hospital Parc de Salut del Mar /ID# 209698
Barcelona, 08003, Spain
Hospital Clinico Universitario San Carlos /ID# 207832
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre /ID# 207827
Madrid, 28041, Spain
Hospital Universitario y Politecnico La Fe /ID# 207831
Valencia, 46026, Spain
Skane University hospital /ID# 210070
Malmo, Skåne County, 214 28, Sweden
Falu Lasarett /ID# 210322
Falun, 791 31, Sweden
Duplicate_Karolinska Univ Sjukhuset /ID# 208175
Solna, 171 64, Sweden
Uppsala University Hospital /ID# 207944
Uppsala, 75185, Sweden
Duplicate_Vastmanlands Sjukhus /ID# 207943
Västerås, 723 35, Sweden
Orebro Universitetssjukhuset /ID# 207948
Örebro, Örebro County, 701 85, Sweden
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 207567
Chiayi City, 62247, Taiwan
Chung Shan Medical University Hospital /ID# 207257
Taichung, 40201, Taiwan
Linkou Chang Gung Memorial Ho /ID# 207255
Taoyuan, 333, Taiwan
State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 209556
Kharkiv, Kharkivs’ka Oblast’, 61039, Ukraine
Scientific Research Institute of Invalid Rehabilitation /ID# 207873
Vinnytsia, Vinnytsia Oblast, 21029, Ukraine
CNE Cherkasy Regional Hospital of Cherkasy Regional Council /ID# 207912
Cherkasy, 18009, Ukraine
MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 207730
Chernihiv, 14029, Ukraine
PNE City Multifunctional Hospital No.18 /ID# 207911
Kharkiv, 61029, Ukraine
Khmelnytskyi Regional Hospital /ID# 207753
Khmelnytskyi, 29000, Ukraine
MI Kryvyi Rih City Clinical Hospital No.2 /ID# 207748
Kryvyi Rih, 50056, Ukraine
Medical Center OK Clinic /ID# 207749
Kyiv, 02091, Ukraine
Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 208276
Lutsk, 43005, Ukraine
Lviv Municipal City Clinical Hospital #4 /ID# 207715
Lviv, 79011, Ukraine
PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 207872
Poltava, 36011, Ukraine
Public Institution 6th City Clinical Hospital /ID# 207754
Zaporizhzhia, 69035, Ukraine
Duplicate_Barts Health NHS Trust /ID# 210534
London, London, City of, E11 1NR, United Kingdom
NHS Greater Glasgow and Clyde /ID# 214942
Glasgow, Scotland, G12 0XH, United Kingdom
Midlands Partnership NHS Foundation Trust /ID# 214941
Stafford, Staffordshire, ST16 3SR, United Kingdom
Manchester University NHS Foundation Trust /ID# 207928
Manchester, M13 9WL, United Kingdom
Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210535
Metropolitan Borough of Wirral, CH49 5PE, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 207932
Portsmouth, PO6 3LY, United Kingdom
Torbay and South Devon Nhs Foundation Trust /Id# 207931
Torquay, TQ2 7AA, United Kingdom
Related Publications (9)
Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Behrens F. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022 Feb;81(2):225-231. doi: 10.1136/annrheumdis-2021-221019. Epub 2021 Dec 15.
PMID: 34911706RESULTGossec L, Balanescu A, D'Agostino MA, Ogdie A, Sewerin P, Deng Y, Shi L, Sugimoto Y, Zhong S, Xing Y, Lippe R, Kishimoto M. Efficacy of Risankizumab across distinct PsA phenotypes identified with machine learning analytics using data from biologic DMARD-Naive patients in two phase 3 clinical trials. Arthritis Res Ther. 2025 Nov 29;28(1):2. doi: 10.1186/s13075-025-03670-0.
PMID: 41318485DERIVEDOstor 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 Dec;12(6):1103-1123. doi: 10.1007/s40744-025-00793-3. Epub 2025 Sep 30.
PMID: 41028616DERIVEDMease 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.
PMID: 39120849DERIVEDKwatra 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.
PMID: 38739215DERIVEDKristensen LE, Keiserman M, Papp K, McCasland L, White D, Carter K, Lippe R, Photowala H, Drogaris L, Soliman AM, Chen M, Padilla B, Behrens F. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the Phase 3 KEEPsAKE 1 Randomized Clinical Trial. Rheumatol Ther. 2024 Jun;11(3):617-632. doi: 10.1007/s40744-024-00654-5. Epub 2024 Mar 18.
PMID: 38498141DERIVEDKristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Soliman AM, Eldred A, Barcomb L, Behrens F. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2023 Jun 1;62(6):2113-2121. doi: 10.1093/rheumatology/keac607.
PMID: 36282530DERIVEDThakre 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.
PMID: 36178584DERIVEDKristensen LE, Soliman AM, Papp K, White D, Barcomb L, Lu W, Eldred A, Behrens F. Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis: results of KEEPsAKE 1. Rheumatology (Oxford). 2023 Feb 1;62(2):629-637. doi: 10.1093/rheumatology/keac342.
PMID: 35801915DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2018
First Posted
September 18, 2018
Study Start
March 25, 2019
Primary Completion
October 8, 2020
Study Completion (Estimated)
September 28, 2026
Last Updated
August 5, 2025
Results First Posted
February 24, 2022
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.