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)
KEEPsAKE2
A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2)
2 other identifiers
interventional
444
24 countries
135
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2019
Longer than P75 for phase_3
135 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 14, 2018
CompletedStudy Start
First participant enrolled
March 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2020
CompletedResults Posted
Study results publicly available
March 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedAugust 29, 2025
August 1, 2025
1.3 years
September 12, 2018
February 1, 2022
August 11, 2025
Conditions
Keywords
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 (10)
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 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Baseline and Week 24
- +5 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
Placebo for risankizumab administered by subcutaneous (SC) injection
Risankizumab administered by subcutaneous (SC) injection
Eligibility Criteria
You may qualify if:
- 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).
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (138)
Pinnacle Research Group /ID# 167953
Anniston, Alabama, 36207, United States
St. Jude Heritage /ID# 166842
Fullerton, California, 92835, United States
Newport Huntington Medica /ID# 207423
Huntington Beach, California, 92648-5994, United States
Arthritis & Osteo Medical Ctr /ID# 166541
La Palma, California, 90623-1728, United States
East Bay Rheumatology Medical /ID# 166845
San Leandro, California, 94578, United States
Inland Rheum Clin Trials Inc. /ID# 166621
Upland, California, 91786, United States
Denver Arthritis Clinic /ID# 166442
Denver, Colorado, 80230, United States
New England Research Associates, LLC /ID# 166525
Bridgeport, Connecticut, 06606-1827, United States
Yale University /ID# 166330
New Haven, Connecticut, 06510, United States
Arthritis & Rheumatic Disease Specialties /ID# 212582
Aventura, Florida, 33180, United States
SIMED Health, LLC /ID# 207457
Gainesville, Florida, 32607-2817, United States
Sweet Hope Research Specialty Inc /ID# 168163
Hialeah, Florida, 33016-1897, United States
Rheum Assoc of Central FL /ID# 201629
Orlando, Florida, 32806, United States
HMD Research LLC /ID# 208428
Orlando, Florida, 32819, United States
Millennium Research /ID# 201627
Ormond Beach, Florida, 32174, United States
Arthritis Center, Inc. /ID# 208116
Palm Harbor, Florida, 34684, United States
IRIS Research and Development, LLC /ID# 166351
Plantation, Florida, 33324, United States
BayCare Medical Group /ID# 201630
St. Petersburg, Florida, 33705, United States
West Broward Rheumatology Associates /ID# 201234
Tamarac, Florida, 33321, United States
University of South Florida /ID# 208467
Tampa, Florida, 33612, United States
ForCare Clinical Research /ID# 166375
Tampa, Florida, 33613-1244, United States
Arthritis and Rheumatology /ID# 169438
Atlanta, Georgia, 30342, United States
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681
Skokie, Illinois, 60076, United States
Springfield Clinic /ID# 166345
Springfield, Illinois, 62702-3749, United States
Ochsner Clinic Foundation /ID# 166622
Baton Rouge, Louisiana, 70836-6455, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 166707
Monroe, Louisiana, 71203, United States
MMP Women's Health /ID# 169334
Portland, Maine, 04102, United States
Klein and Associates MD /ID# 166549
Hagerstown, Maryland, 21740, United States
Duplicate_The Center for Rheumatology & Bone Research /ID# 166448
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Gr /ID# 166455
Worcester, Massachusetts, 01605, United States
St. Paul Rheumatology /ID# 166599
Eagan, Minnesota, 55121, United States
Clinvest Research LLC /ID# 166745
Springfield, Missouri, 65810-2607, United States
Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389
St Louis, Missouri, 63119-3845, United States
Glacier View Research Institute /ID# 169344
Kalispell, Montana, 59901, United States
Dartmouth-Hitchcock Medical Center /ID# 169443
Lebanon, New Hampshire, 03756, United States
Ocean Rheumatology, PA /ID# 166561
Toms River, New Jersey, 08755, United States
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658
Voorhees Township, New Jersey, 08043, United States
Paramount Medical Research Con /ID# 166334
Middleburg Heights, Ohio, 44130, United States
Health Research of Oklahoma /ID# 166408
Oklahoma City, Oklahoma, 73103-2400, United States
Altoona Ctr Clinical Res /ID# 166691
Duncansville, Pennsylvania, 16635, United States
Clinical Research Ctr Reading /ID# 166354
Wyomissing, Pennsylvania, 19610, United States
West Tennessee Research Institute /ID# 166429
Jackson, Tennessee, 38305, United States
Nashville Arthritis and Rheumatology /ID# 208395
Nashville, Tennessee, 37203, United States
Amarillo Ctr for Clin Research /ID# 208340
Amarillo, Texas, 79124, United States
Tekton Research, Inc. /ID# 166493
Austin, Texas, 78745, United States
Precision Comprehensive Clinical Research Solutions /ID# 208156
Colleyville, Texas, 76034, United States
Rheumatology Clinic of Houston /ID# 166636
Houston, Texas, 77065, United States
West Texas Clinical Research /ID# 208155
Lubbock, Texas, 79410-1198, United States
SW Rheumatology Res. LLC /ID# 166587
Mesquite, Texas, 75150, United States
Trinity Universal Research Associates, Inc /ID# 208387
Plano, Texas, 75024-5283, United States
DM Clinical Research /ID# 208350
Tomball, Texas, 77375, United States
Kadlec Clinic Rheumatology /ID# 167667
Kennewick, Washington, 99336, United States
Arthritis Northwest, PLLC /ID# 169535
Spokane, Washington, 99204-2302, United States
Rheumatology and Pulmonary Clinic /ID# 169341
Beckley, West Virginia, 25801, United States
Rheumatic Disease Center, LLP /ID# 166682
Glendale, Wisconsin, 53217, United States
Hospital General de Agudos J. M. Ramos Mejia /ID# 169152
Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1221, Argentina
Hospital Italiano de Buenos Aires /ID# 208473
Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1199, Argentina
DOM Centro de Reumatologia /ID# 208478
Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1111, Argentina
Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151
Rosario, Santa Fe Province, 2000, Argentina
Instituto CAICI /ID# 169156
Rosario, Santa Fe Province, 2000, Argentina
Centro Medico Privado de Reumatologia /ID# 208342
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Cimer /Id# 169155
San Miguel de Tucumán, 4000, Argentina
The Canberra Hospital /ID# 207591
Garran, Australian Capital Territory, 2605, Australia
Rheumatology Research Unit Sunshine Coast /ID# 207191
Maroochydore, Queensland, 4558, Australia
Griffith University /ID# 207504
Southport, Queensland, 4222, Australia
Emeritus Research /ID# 207195
Camberwell, Victoria, 3124, Australia
Monash Medical Centre /ID# 208033
Clayton, Victoria, 3168, Australia
UZ Gent /ID# 210037
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 208209
Leuven, Vlaams-Brabant, 3000, Belgium
ReumaClinic /ID# 208211
Genk, 3600, Belgium
ZNA - Jan Palfijn /ID# 208210
Merksem, 2170, Belgium
CIP - Centro Internacional de Pesquisa /ID# 169524
Goiânia, Goiás, 74110-120, Brazil
LMK Sevicos Medicos S/S /ID# 169541
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
Percuro Clinical Research, Ltd /ID# 169530
Victoria, British Columbia, V8V 3M9, Canada
CIADS Research Co Ltd /ID# 169526
Winnipeg, Manitoba, R3N 0K6, Canada
Dermatrials Research /ID# 208303
Hamilton, Ontario, L8N 1Y2, Canada
K. Papp Clinical Research /ID# 169527
Waterloo, Ontario, N2J 1C4, Canada
Centre Rhumatologie de l'Est /ID# 208302
Rimouski, Quebec, G5L 8W1, Canada
Bispebjerg and Frederiksberg Hospital /ID# 168763
Frederiksberg, Capital Region, 2000, Denmark
Aarhus University Hospital /ID# 168762
Aarhus C, Central Jutland, 8000, Denmark
East Tallinn Central Hospital /ID# 208317
Tallinn, Harju, 10138, Estonia
MediTrials /ID# 207815
Tartu, Tartu, 50708, Estonia
North Estonia Medical Centre /ID# 208319
Tallinn, 13419, Estonia
Ite Pihlajanlinna Kuopio /ID# 208316
Kuopio, 70100, Finland
Turku University Hospital /ID# 208199
Turku, 20520, Finland
Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159
Bordeaux, 33076, France
CHRU Tours - Hopital Trousseau /ID# 209343
Chambray-lès-Tours, 37170, France
Rheumazentrum Ruhrgebiet /ID# 207212
Herne, North Rhine-Westphalia, 44649, Germany
Immanuel Krankenhaus Berlin /ID# 207214
Buch, 13125, Germany
Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494
Frankfurt, 60590, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493
Hamburg, 20095, Germany
University General Hospital of Heraklion PA.G.N.I /ID# 206930
Heraklion, Crete, 71307, Greece
Naval Hospital of Athens /ID# 206928
Athens, 11521, Greece
Olympion General Clinic SA /ID# 207047
Pátrai, 26443, Greece
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248
Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237
Szeged, Csongrád megye, 6725, Hungary
Vital-Medicina Kft. /ID# 208123
Veszprém, Veszprém megye, 8200, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054
Budapest, 1023, Hungary
Sheba Medical Center /ID# 207468
Ramat Gan, Tel Aviv, 5239424, Israel
Barzilai Medical Center /ID# 207471
Ashkelon, 7830604, Israel
Rambam Health Care Campus /ID# 208169
Haifa, 3109601, Israel
Meir Medical Center /ID# 207469
Kfar Saba, 4428164, Israel
Rabin Medical Center /ID# 207470
Petah Tikva, 4941492, Israel
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800
Modena, Emilia-Romagna, 41124, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268
Ancona, 60126, Italy
Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264
Verona, 37134, Italy
Antonius Ziekenhuis /ID# 208581
Sneek, Provincie Friesland, 8601 ZK, Netherlands
Universitair Medisch Centrum Groningen /ID# 168450
Groningen, 9713 GZ, Netherlands
Medisch Centrum Leeuwarden /ID# 168449
Leeuwarden, 8934 AD, Netherlands
Waikato Hospital /ID# 214276
Hamilton, Waikato Region, 3204, New Zealand
Middlemore Clinical Trials /ID# 214293
Auckland, 2025, New Zealand
CGM Research Trust /ID# 210596
Burwood Christchurch, 8083, New Zealand
Malopolskie Centrum Kliniczne /ID# 208011
Krakow, Lesser Poland Voivodeship, 30-149, Poland
Centrum Medyczne Reuma Park w Warszawie /ID# 210956
Warsaw, Masovian Voivodeship, 02-691, Poland
Osteo-Medic S.C. /ID# 208013
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012
Gdansk, Pomeranian Voivodeship, 80-546, Poland
Centrum Kliniczno-Badawcze /ID# 208014
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138
Ponte de Lima, Viana do Castelo District, 4990-041, Portugal
Instituto Português De Reumatologia /ID# 208140
Lisbon, 1050-034, Portugal
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139
Lisbon, 1649-035, Portugal
GCM Medical Group PSC - Hato Rey /ID# 208461
San Juan, 00917-3104, Puerto Rico
Changi General Hospital /ID# 208966
Singapore, 529889, Singapore
Dr Jenny Potts /ID# 167628
Port Elizabeth, Eastern Cape, 6405, South Africa
Arthritis Clinical Research Trials /ID# 167611
Cape Town, Western Cape, 7405, South Africa
Winelands Medical Research Centre /ID# 167630
Stellenbosch, Western Cape, 7600, South Africa
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822
Sabadell, Barcelona, 08208, Spain
Hospital Unversitario Marques de Valdecilla /ID# 208541
Santander, Cantabria, 39008, Spain
Hospital Universitario A Coruna - CHUAC /ID# 207819
A Coruña, 15006, Spain
Hospital Universitario 12 de Octubre /ID# 207820
Madrid, 28041, Spain
Hospital Universitario y Politecnico La Fe /ID# 207823
Valencia, 46026, Spain
Duplicate_Karolinska Univ Sjukhuset /ID# 208174
Solna, 171 64, Sweden
Uppsala University Hospital /ID# 169098
Uppsala, 75185, Sweden
Duplicate_Vastmanlands Sjukhus /ID# 168620
Västerås, 723 35, Sweden
Orebro Universitetssjukhuset /ID# 169400
Örebro, Örebro County, 701 85, Sweden
Duplicate_Barts Health NHS Trust /ID# 210794
London, London, City of, E11 1NR, United Kingdom
Manchester University NHS Foundation Trust /ID# 207923
Manchester, M13 9WL, United Kingdom
Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536
Metropolitan Borough of Wirral, CH49 5PE, United Kingdom
Torbay and South Devon Nhs Foundation Trust /Id# 207926
Torquay, TQ2 7AA, United Kingdom
Related Publications (9)
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.
PMID: 34815219RESULTGossec 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: 38739215DERIVEDOstor 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.
PMID: 38498139DERIVEDOstor 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.
PMID: 36282537DERIVEDThakre 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: 36178584DERIVEDOstor 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.
PMID: 35701011DERIVED
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 14, 2018
Study Start
March 7, 2019
Primary Completion
June 22, 2020
Study Completion (Estimated)
June 1, 2026
Last Updated
August 29, 2025
Results First Posted
March 2, 2022
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- 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.