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AzTrials

Psoriatic Arthritis (PsA)Phase 3KEEPsAKE2NCT03671148

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)

A Phase 3 study testing Risankizumab in people with Psoriatic Arthritis (PsA), run by AbbVie at 138 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis (PsA)
What is being tested?
Risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
444 participants
Where
138 sitesin 25 countries
Study dates
7 Mar 2019to 4 Jun 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant has a known hypersensitivity to risankizumab.

Trial locations and contacts

138 sites in 25 countries.

138 sites in 25 countries

United States55 sites

  • Amarillo Ctr for Clin Research /ID# 208340

    Amarillo, Texas, 79124

  • Pinnacle Research Group /ID# 167953

    Anniston, Alabama, 36207

  • Arthritis and Rheumatology /ID# 169438

    Atlanta, Georgia, 30342

  • Tekton Research, Inc. /ID# 166493

    Austin, Texas, 78745

  • Arthritis & Rheumatic Disease Specialties /ID# 212582

    Aventura, Florida, 33180

  • Ochsner Clinic Foundation /ID# 166622

    Baton Rouge, Louisiana, 70836-6455

  • Rheumatology and Pulmonary Clinic /ID# 169341

    Beckley, West Virginia, 25801

  • New England Research Associates, LLC /ID# 166525

    Bridgeport, Connecticut, 06606-1827

  • Precision Comprehensive Clinical Research Solutions /ID# 208156

    Colleyville, Texas, 76034

  • Denver Arthritis Clinic /ID# 166442

    Denver, Colorado, 80230

  • Altoona Ctr Clinical Res /ID# 166691

    Duncansville, Pennsylvania, 16635

  • St. Paul Rheumatology /ID# 166599

    Eagan, Minnesota, 55121

  • St. Jude Heritage /ID# 166842

    Fullerton, California, 92835

  • SIMED Health, LLC /ID# 207457

    Gainesville, Florida, 32607-2817

  • Rheumatic Disease Center, LLP /ID# 166682

    Glendale, Wisconsin, 53217

  • Klein and Associates MD /ID# 166549

    Hagerstown, Maryland, 21740

  • Sweet Hope Research Specialty Inc /ID# 168163

    Hialeah, Florida, 33016-1897

  • Rheumatology Clinic of Houston /ID# 166636

    Houston, Texas, 77065

  • Newport Huntington Medica /ID# 207423

    Huntington Beach, California, 92648-5994

  • West Tennessee Research Institute /ID# 166429

    Jackson, Tennessee, 38305

  • Glacier View Research Institute /ID# 169344

    Kalispell, Montana, 59901

  • Kadlec Clinic Rheumatology /ID# 167667

    Kennewick, Washington, 99336

  • Arthritis & Osteo Medical Ctr /ID# 166541

    La Palma, California, 90623-1728

  • Dartmouth-Hitchcock Medical Center /ID# 169443

    Lebanon, New Hampshire, 03756

  • West Texas Clinical Research /ID# 208155

    Lubbock, Texas, 79410-1198

  • SW Rheumatology Res. LLC /ID# 166587

    Mesquite, Texas, 75150

  • Paramount Medical Research Con /ID# 166334

    Middleburg Heights, Ohio, 44130

  • The Arthritis & Diabetes Clinic, Inc. /ID# 166707

    Monroe, Louisiana, 71203

  • Nashville Arthritis and Rheumatology /ID# 208395

    Nashville, Tennessee, 37203

  • Yale University /ID# 166330

    New Haven, Connecticut, 06510

  • Health Research of Oklahoma /ID# 166408

    Oklahoma City, Oklahoma, 73103-2400

  • Rheum Assoc of Central FL /ID# 201629

    Orlando, Florida, 32806

  • HMD Research LLC /ID# 208428

    Orlando, Florida, 32819

  • Millennium Research /ID# 201627

    Ormond Beach, Florida, 32174

  • Arthritis Center, Inc. /ID# 208116

    Palm Harbor, Florida, 34684

  • Trinity Universal Research Associates, Inc /ID# 208387

    Plano, Texas, 75024-5283

  • IRIS Research and Development, LLC /ID# 166351

    Plantation, Florida, 33324

  • MMP Women's Health /ID# 169334

    Portland, Maine, 04102

  • East Bay Rheumatology Medical /ID# 166845

    San Leandro, California, 94578

  • Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681

    Skokie, Illinois, 60076

  • Arthritis Northwest, PLLC /ID# 169535

    Spokane, Washington, 99204-2302

  • Springfield Clinic /ID# 166345

    Springfield, Illinois, 62702-3749

  • Clinvest Research LLC /ID# 166745

    Springfield, Missouri, 65810-2607

  • Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389

    St Louis, Missouri, 63119-3845

  • BayCare Medical Group /ID# 201630

    St. Petersburg, Florida, 33705

  • West Broward Rheumatology Associates /ID# 201234

    Tamarac, Florida, 33321

  • University of South Florida /ID# 208467

    Tampa, Florida, 33612

  • ForCare Clinical Research /ID# 166375

    Tampa, Florida, 33613-1244

  • DM Clinical Research /ID# 208350

    Tomball, Texas, 77375

  • Ocean Rheumatology, PA /ID# 166561

    Toms River, New Jersey, 08755

  • Inland Rheum Clin Trials Inc. /ID# 166621

    Upland, California, 91786

  • Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658

    Voorhees Township, New Jersey, 08043

  • Duplicate_The Center for Rheumatology & Bone Research /ID# 166448

    Wheaton, Maryland, 20902

  • Clinical Pharmacology Study Gr /ID# 166455

    Worcester, Massachusetts, 01605

  • Clinical Research Ctr Reading /ID# 166354

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Argentina7 sites

  • Hospital General de Agudos J. M. Ramos Mejia /ID# 169152

    Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1221

  • Hospital Italiano de Buenos Aires /ID# 208473

    Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1199

  • DOM Centro de Reumatologia /ID# 208478

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1111

  • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151

    Rosario, Santa Fe Province, 2000

  • Instituto CAICI /ID# 169156

    Rosario, Santa Fe Province, 2000

  • Centro Medico Privado de Reumatologia /ID# 208342

    San Miguel de Tucumán, Tucumán Province, 4000

  • Cimer /Id# 169155

    San Miguel de Tucumán, 4000

Other trials in Argentina

Australia5 sites

  • Emeritus Research /ID# 207195

    Camberwell, Victoria, 3124

  • Monash Medical Centre /ID# 208033

    Clayton, Victoria, 3168

  • The Canberra Hospital /ID# 207591

    Garran, Australian Capital Territory, 2605

  • Rheumatology Research Unit Sunshine Coast /ID# 207191

    Maroochydore, Queensland, 4558

  • Griffith University /ID# 207504

    Southport, Queensland, 4222

Other trials in Australia

Canada5 sites

  • Dermatrials Research /ID# 208303

    Hamilton, Ontario, L8N 1Y2

  • Centre Rhumatologie de l'Est /ID# 208302

    Rimouski, Quebec, G5L 8W1

  • Percuro Clinical Research, Ltd /ID# 169530

    Victoria, British Columbia, V8V 3M9

  • K. Papp Clinical Research /ID# 169527

    Waterloo, Ontario, N2J 1C4

  • CIADS Research Co Ltd /ID# 169526

    Winnipeg, Manitoba, R3N 0K6

Other trials in Canada

Israel5 sites

  • Barzilai Medical Center /ID# 207471

    Ashkelon, 7830604

  • Rambam Health Care Campus /ID# 208169

    Haifa, 3109601

  • Meir Medical Center /ID# 207469

    Kfar Saba, 4428164

  • Rabin Medical Center /ID# 207470

    Petah Tikva, 4941492

  • Sheba Medical Center /ID# 207468

    Ramat Gan, Tel Aviv, 5239424

Other trials in Israel

Poland5 sites

  • Osteo-Medic S.C. /ID# 208013

    Bialystok, Podlaskie Voivodeship, 15-351

  • Centrum Kliniczno-Badawcze /ID# 208014

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012

    Gdansk, Pomeranian Voivodeship, 80-546

  • Malopolskie Centrum Kliniczne /ID# 208011

    Krakow, Lesser Poland Voivodeship, 30-149

  • Centrum Medyczne Reuma Park w Warszawie /ID# 210956

    Warsaw, Masovian Voivodeship, 02-691

Other trials in Poland

Spain5 sites

  • Hospital Universitario A Coruna - CHUAC /ID# 207819

    A Coruña, 15006

  • Hospital Universitario 12 de Octubre /ID# 207820

    Madrid, 28041

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822

    Sabadell, Barcelona, 08208

  • Hospital Unversitario Marques de Valdecilla /ID# 208541

    Santander, Cantabria, 39008

  • Hospital Universitario y Politecnico La Fe /ID# 207823

    Valencia, 46026

Other trials in Spain

Belgium4 sites

  • ReumaClinic /ID# 208211

    Genk, 3600

  • UZ Gent /ID# 210037

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven /ID# 208209

    Leuven, Vlaams-Brabant, 3000

  • ZNA - Jan Palfijn /ID# 208210

    Merksem, 2170

Other trials in Belgium

Germany4 sites

  • Immanuel Krankenhaus Berlin /ID# 207214

    Buch, 13125

  • Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494

    Frankfurt, 60590

  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493

    Hamburg, 20095

  • Rheumazentrum Ruhrgebiet /ID# 207212

    Herne, North Rhine-Westphalia, 44649

Other trials in Germany

Hungary4 sites

  • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054

    Budapest, 1023

  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237

    Szeged, Csongrád megye, 6725

  • Vital-Medicina Kft. /ID# 208123

    Veszprém, Veszprém megye, 8200

Other trials in Hungary

Sweden4 sites

  • Orebro Universitetssjukhuset /ID# 169400

    Örebro, Örebro County, 701 85

  • Duplicate_Karolinska Univ Sjukhuset /ID# 208174

    Solna, 171 64

  • Uppsala University Hospital /ID# 169098

    Uppsala, 75185

  • Duplicate_Vastmanlands Sjukhus /ID# 168620

    Västerås, 723 35

Other trials in Sweden

United Kingdom4 sites

  • Duplicate_Barts Health NHS Trust /ID# 210794

    London, London, City of, E11 1NR

  • Manchester University NHS Foundation Trust /ID# 207923

    Manchester, M13 9WL

  • Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536

    Metropolitan Borough of Wirral, CH49 5PE

  • Torbay and South Devon Nhs Foundation Trust /Id# 207926

    Torquay, TQ2 7AA

Other trials in United Kingdom

Estonia3 sites

  • East Tallinn Central Hospital /ID# 208317

    Tallinn, Harju, 10138

  • North Estonia Medical Centre /ID# 208319

    Tallinn, 13419

  • MediTrials /ID# 207815

    Tartu, Tartu, 50708

Other trials in Estonia

Greece3 sites

  • Naval Hospital of Athens /ID# 206928

    Athens, 11521

  • University General Hospital of Heraklion PA.G.N.I /ID# 206930

    Heraklion, Crete, 71307

  • Olympion General Clinic SA /ID# 207047

    Pátrai, 26443

Other trials in Greece

Italy3 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268

    Ancona, 60126

  • Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800

    Modena, Emilia-Romagna, 41124

  • Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264

    Verona, 37134

Other trials in Italy

Netherlands3 sites

  • Universitair Medisch Centrum Groningen /ID# 168450

    Groningen, 9713 GZ

  • Medisch Centrum Leeuwarden /ID# 168449

    Leeuwarden, 8934 AD

  • Antonius Ziekenhuis /ID# 208581

    Sneek, Provincie Friesland, 8601 ZK

Other trials in Netherlands

New Zealand3 sites

  • Middlemore Clinical Trials /ID# 214293

    Auckland, 2025

  • CGM Research Trust /ID# 210596

    Burwood Christchurch, 8083

  • Waikato Hospital /ID# 214276

    Hamilton, Waikato Region, 3204

Other trials in New Zealand

Portugal3 sites

  • Instituto Português De Reumatologia /ID# 208140

    Lisbon, 1050-034

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139

    Lisbon, 1649-035

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138

    Ponte de Lima, Viana do Castelo District, 4990-041

Other trials in Portugal

South Africa3 sites

  • Arthritis Clinical Research Trials /ID# 167611

    Cape Town, Western Cape, 7405

  • Dr Jenny Potts /ID# 167628

    Port Elizabeth, Eastern Cape, 6405

  • Winelands Medical Research Centre /ID# 167630

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

Brazil2 sites

  • CIP - Centro Internacional de Pesquisa /ID# 169524

    Goiânia, Goiás, 74110-120

  • LMK Sevicos Medicos S/S /ID# 169541

    Porto Alegre, Rio Grande do Sul, 90480-000

Other trials in Brazil

Denmark2 sites

  • Aarhus University Hospital /ID# 168762

    Aarhus C, Central Jutland, 8000

  • Bispebjerg and Frederiksberg Hospital /ID# 168763

    Frederiksberg, Capital Region, 2000

Other trials in Denmark

Finland2 sites

  • Ite Pihlajanlinna Kuopio /ID# 208316

    Kuopio, 70100

  • Turku University Hospital /ID# 208199

    Turku, 20520

Other trials in Finland

France2 sites

  • Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159

    Bordeaux, 33076

  • CHRU Tours - Hopital Trousseau /ID# 209343

    Chambray-lès-Tours, 37170

Other trials in France

Puerto Rico1 site

  • GCM Medical Group PSC - Hato Rey /ID# 208461

    San Juan, 00917-3104

Other trials in Puerto Rico

Singapore1 site

  • Changi General Hospital /ID# 208966

    Singapore, 529889

Other trials in Singapore

About this study

Official title: 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)

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

Read the detailed 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.

Being tested
Placebo, Risankizumab
Keywords
KEEPsAKE 2, Risankizumab
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboBiological

    Placebo for risankizumab administered by subcutaneous (SC) injection

  • RisankizumabBiological

    Also called ABBV-066, BI 655066, SKYRIZI

    Risankizumab administered by subcutaneous (SC) injection

Study groups in NCT03671148
Study groupRoleWhat they receive
RisankizumabExperimentalParticipants 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.
Receives: Biological: Placebo; Biological: Risankizumab
PlaceboPlacebo 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.
Receives: Biological: Placebo; Biological: Risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline and Week 24

Secondary outcomes (10)

  1. Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24

    The Health Assessment Questionnaire Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.

    A negative change from Baseline in the overall score indicates improvement.

    Measured: Baseline and Week 24

  2. Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24

    PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).

    The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from Baseline in PASI score.

    Measured: Baseline and Week 24

  3. Percentage of Participants With an ACR20 Response at Week 16

    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).

    Measured: Baseline and Week 16

  4. Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24

    A participant was classified as achieving MDA if 5 of the following 7 criteria were met:

    • Tender joint count (out of 68 joints) ≤ 1
    • Swollen joint count (out of 66 joints) ≤ 1
    • PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3%
    • Patient's assessment of pain ≤ 15 (VAS from 0 to 100)
    • Patient's Global Assessment of disease activity ≤ 20 (VAS from 0 to 100)
    • HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3)
    • Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, for an overall score range from 0 to 6)

    Measured: Week 24

  5. Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

    The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

    The physical component summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from Baseline score indicates improvement.

    Measured: Baseline and Week 24

  6. Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24

    The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.

    Measured: Baseline and Week 24

  7. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:

    1. ≥ 50% improvement in 68-tender joint count;
    2. ≥ 50% improvement in 66-swollen joint count; and
    3. ≥ 50% 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).

    Measured: Baseline and Week 24

  8. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:

    1. ≥ 70% improvement in 68-tender joint count;
    2. ≥ 70% improvement in 66-swollen joint count; and
    3. ≥ 70% 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).

    Measured: Baseline and Week 24

  9. Percentage of Participants With Resolution of Enthesitis at Week 24

    Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0.

    LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst).

    Measured: Week 24

  10. Percentage of Participants With Resolution of Dactylitis at Week 24

    Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.

    The LDI basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). If both sides of a digit are considered involved, or the circumference of the contralateral digit cannot be obtained, a standard reference table is used.

    Scores from each digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start7 Mar 2019
  3. Primary completion22 Jun 2020
  4. Study completion4 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671148
Sponsor's protocol ID
M15-998
Other IDs
2023-505477-33, 2023
Acronym
KEEPsAKE2
Status last verified
Jun 2026
First submitted
12 Sep 2018
Last updated
20 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34815219

  • Gossec 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.

    PubMed 41318485

  • 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 Dec;12(6):1103-1123. doi: 10.1007/s40744-025-00793-3. Epub 2025 Sep 30.

    PubMed 41028616

  • 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.

    PubMed 39120849

  • 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.

    PubMed 38739215

  • 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.

    PubMed 38498139

  • 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.

    PubMed 36282537

  • 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.

    PubMed 36178584

  • 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.

    PubMed 35701011

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab in people with Psoriatic Arthritis (PsA), run by AbbVie at 138 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Argentina, Australia, Canada, Israel and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03671148, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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