Clinical trial NCT03671148: 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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis (PsA)
Keywords: KEEPsAKE 2
Risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an ACR20 Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
timeFrame: Week 24
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Resolution of Enthesitis at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Resolution of Dactylitis at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group /ID# 167953
state: Alabama
city: Fullerton
country: United States
facility: St. Jude Heritage /ID# 166842
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Medica /ID# 207423
state: California
city: La Palma
country: United States
facility: Arthritis & Osteo Medical Ctr /ID# 166541
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical /ID# 166845
state: California
city: Upland
country: United States
facility: Inland Rheum Clin Trials Inc. /ID# 166621
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic /ID# 166442
state: Colorado
city: Bridgeport
country: United States
facility: New England Research Associates, LLC /ID# 166525
state: Connecticut
city: New Haven
country: United States
facility: Yale University /ID# 166330
state: Connecticut
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties /ID# 212582
state: Florida
city: Gainesville
country: United States
facility: SIMED Health, LLC /ID# 207457
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty Inc /ID# 168163
state: Florida
city: Orlando
country: United States
facility: Rheum Assoc of Central FL /ID# 201629
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC /ID# 208428
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research /ID# 201627
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc. /ID# 208116
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC /ID# 166351
state: Florida
city: Saint Petersburg
country: United States
facility: BayCare Medical Group /ID# 201630
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates /ID# 201234
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 208467
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research /ID# 166375
state: Florida
city: Atlanta
country: United States
facility: Arthritis and Rheumatology /ID# 169438
state: Georgia
city: Skokie
country: United States
facility: Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic /ID# 166345
state: Illinois
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation /ID# 166622
state: Louisiana
city: Monroe
country: United States
facility: The Arthritis & Diabetes Clinic, Inc. /ID# 166707
state: Louisiana
city: Portland
country: United States
facility: MMP Women's Health /ID# 169334
state: Maine
city: Hagerstown
country: United States
facility: Klein and Associates MD /ID# 166549
state: Maryland
city: Wheaton
country: United States
facility: Duplicate_The Center for Rheumatology & Bone Research /ID# 166448
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Gr /ID# 166455
state: Massachusetts
city: Eagan
country: United States
facility: St. Paul Rheumatology /ID# 166599
state: Minnesota
city: Saint Louis
country: United States
facility: Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 166745
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute /ID# 169344
state: Montana
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 169443
state: New Hampshire
city: Toms River
country: United States
facility: Ocean Rheumatology, PA /ID# 166561
state: New Jersey
city: Voorhees
country: United States
facility: Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658
state: New Jersey
city: Middleburg Heights
country: United States
facility: Paramount Medical Research Con /ID# 166334
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma /ID# 166408
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Ctr Clinical Res /ID# 166691
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Ctr Reading /ID# 166354
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute /ID# 166429
state: Tennessee
city: Nashville
country: United States
facility: Nashville Arthritis and Rheumatology /ID# 208395
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Ctr for Clin Research /ID# 208340
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc. /ID# 166493
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions /ID# 208156
state: Texas
city: Houston
country: United States
facility: Rheumatology Clinic of Houston /ID# 166636
state: Texas
city: Lubbock
country: United States
facility: West Texas Clinical Research /ID# 208155
state: Texas
city: Mesquite
country: United States
facility: SW Rheumatology Res. LLC /ID# 166587
state: Texas
city: Plano
country: United States
facility: Trinity Universal Research Associates, Inc /ID# 208387
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research /ID# 208350
state: Texas
city: Kennewick
country: United States
facility: Kadlec Clinic Rheumatology /ID# 167667
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC /ID# 169535
state: Washington
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic /ID# 169341
state: West Virginia
city: Glendale
country: United States
facility: Rheumatic Disease Center, LLP /ID# 166682
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos J. M. Ramos Mejia /ID# 169152
state: Ciuadad Autonoma De Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires /ID# 208473
state: Ciuadad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: DOM Centro de Reumatologia /ID# 208478
state: Ciuadad Autonoma De Buenos Aires
city: Rosario
country: Argentina
facility: Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169151
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto CAICI /ID# 169156
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia /ID# 208342
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Cimer /Id# 169155
city: Garran
country: Australia
facility: The Canberra Hospital /ID# 207591
state: Australian Capital Territory
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit Sunshine Coast /ID# 207191
state: Queensland
city: Southport
country: Australia
facility: Griffith University /ID# 207504
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research /ID# 207195
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre /ID# 208033
state: Victoria
city: Gent
country: Belgium
facility: UZ Gent /ID# 210037
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 208209
state: Vlaams-Brabant
city: Genk
country: Belgium
facility: ReumaClinic /ID# 208211
city: Merksem
country: Belgium
facility: ZNA - Jan Palfijn /ID# 208210
city: Goiânia
country: Brazil
facility: CIP - Centro Internacional de Pesquisa /ID# 169524
state: Goias
city: Porto Alegre
country: Brazil
facility: LMK Sevicos Medicos S/S /ID# 169541
state: Rio Grande Do Sul
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 169530
state: British Columbia
city: Winnipeg
country: Canada
facility: CIADS Research Co Ltd /ID# 169526
state: Manitoba
city: Hamilton
country: Canada
facility: Dermatrials Research /ID# 208303
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research /ID# 169527
state: Ontario
city: Rimouski
country: Canada
facility: Centre Rhumatologie de l'Est /ID# 208302
state: Quebec
city: Frederiksberg
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital /ID# 168763
state: Hovedstaden
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital /ID# 168762
state: Midtjylland
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital /ID# 208317
state: Harjumaa
city: Tartu
country: Estonia
facility: MediTrials /ID# 207815
state: Tartumaa
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre /ID# 208319
city: Kuopio
country: Finland
facility: Ite Pihlajanlinna Kuopio /ID# 208316
city: Turku
country: Finland
facility: Turku University Hospital /ID# 208199
city: Bordeaux
country: France
facility: Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159
city: Chambray Les Tours
country: France
facility: CHRU Tours - Hopital Trousseau /ID# 209343
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet /ID# 207212
state: Nordrhein-Westfalen
city: Berlin-buch
country: Germany
facility: Immanuel Krankenhaus Berlin /ID# 207214
city: Frankfurt
country: Germany
facility: Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209494
city: Hamburg
country: Germany
facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209493
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 206930
state: Kriti
city: Athens
country: Greece
facility: Naval Hospital of Athens /ID# 206928
city: Patras
country: Greece
facility: Olympion General Clinic SA /ID# 207047
city: Miskolc
country: Hungary
facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248
state: Borsod-Abauj-Zemplen
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 169237
state: Csongrad
city: Veszprém
country: Hungary
facility: Vital-Medicina Kft. /ID# 208123
state: Veszprem
city: Budapest
country: Hungary
facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 209054
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 207468
state: Tel-Aviv
city: Ashkelon
country: Israel
facility: Barzilai Medical Center /ID# 207471
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 208169
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 207469
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 207470
city: Modena
country: Italy
facility: Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800
state: Emilia-Romagna
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207268
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207264
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis /ID# 208581
state: Fryslan
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 168450
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden /ID# 168449
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 214276
state: Waikato
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials /ID# 214293
city: Burwood Christchurch
country: New Zealand
facility: CGM Research Trust /ID# 210596
city: Krakow
country: Poland
facility: Malopolskie Centrum Kliniczne /ID# 208011
state: Malopolskie
city: Warsaw
country: Poland
facility: Centrum Medyczne Reuma Park w Warszawie /ID# 210956
state: Mazowieckie
city: Bialystok
country: Poland
facility: Osteo-Medic S.C. /ID# 208013
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 208012
state: Pomorskie
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze /ID# 208014
state: Warminsko-mazurskie
city: Ponte de Lima
country: Portugal
facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208138
state: Viana Do Castelo
city: Lisboa
country: Portugal
facility: Instituto Português De Reumatologia /ID# 208140
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208139
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC - Hato Rey /ID# 208461
city: Singapore
country: Singapore
facility: Changi General Hospital /ID# 208966
city: Port Elizabeth
country: South Africa
facility: Dr Jenny Potts /ID# 167628
state: Eastern Cape
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Trials /ID# 167611
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre /ID# 167630
state: Western Cape
city: Sabadell
country: Spain
facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822
state: Barcelona
city: Santander
country: Spain
facility: Hospital Unversitario Marques de Valdecilla /ID# 208541
state: Cantabria
city: A Coruna
country: Spain
facility: Hospital Universitario A Coruna - CHUAC /ID# 207819
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 207820
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 207823
city: Orebro
country: Sweden
facility: Orebro Universitetssjukhuset /ID# 169400
state: Orebro Lan
city: Solna
country: Sweden
facility: Duplicate_Karolinska Univ Sjukhuset /ID# 208174
city: Uppsala
country: Sweden
facility: Uppsala University Hospital /ID# 169098
city: Vasteras
country: Sweden
facility: Duplicate_Vastmanlands Sjukhus /ID# 168620
city: London
country: United Kingdom
facility: Duplicate_Barts Health NHS Trust /ID# 210794
state: London, City Of
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust /ID# 207923
city: Torquay
country: United Kingdom
facility: Torbay and South Devon Nhs Foundation Trust /Id# 207926
city: Wirral
country: United Kingdom
facility: Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210536
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.