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)

Psoriatic Arthritis (PsA) Clinical Trial

— KEEPsAKE2  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03671148
• Other study ID #: M15-998
• Secondary ID: 2017-002464-40
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 7, 2019
• Est. completion date: June 12, 2026

Study information

• Verified date: April 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 444
• Est. completion date: June 12, 2026
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis (PsA)

Intervention

Biological:
• Placebo
Placebo for risankizumab administered by subcutaneous (SC) injection
• Risankizumab
Risankizumab administered by subcutaneous (SC) injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Singapore,  South Africa,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

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, ph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: = 20% improvement in 68-tender joint count; = 20% improvement in 66-swollen joint count; and; = 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	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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: = 20% improvement in 68-tender joint count; = 20% improvement in 66-swollen joint count; and; = 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 16
Secondary	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)	Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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: = 50% improvement in 68-tender joint count; = 50% improvement in 66-swollen joint count; and; = 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).	Baseline and Week 24
Secondary	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: = 70% improvement in 68-tender joint count; = 70% improvement in 66-swollen joint count; and; = 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).	Baseline and Week 24
Secondary	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).	Week 24
Secondary	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.	Week 24

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