The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03671148




Registration number
NCT03671148
Ethics application status
Date submitted
12/09/2018
Date registered
14/09/2018
Date last updated
5/06/2020

Titles & IDs
Public title
A 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)
Scientific 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)
Secondary ID [1] 0 0
2017-002464-40
Secondary ID [2] 0 0
M15-998
Universal Trial Number (UTN)
Trial acronym
KEEPsAKE2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis (PsA) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - placebo for rizankizumab
Other interventions - risankizumab

Experimental: Risankizumab - Participants randomized to receive double-blind risankizumab for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).

Placebo Comparator: Placebo - Participants randomized to receive double-blind placebo for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).


Other interventions: placebo for rizankizumab
Placebo for risankizumab administered by subcutaneous (SC) injection

Other interventions: risankizumab
Risankizumab administered by subcutaneous (SC) injection

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving at least 20% Improvement in American College of Rheumatology (ACR20) - ACR20 is defined as at least 20% improvement in swollen joint count, tender joint count, and at least 3 out of the following 5 variables: 1) Patient's Assessment of psoriatic arthritis (PsA) Pain Intensity visual analog scale (VAS), 2) Patient's Global Assessment of Disease VAS, 3) Physician's Global Assessment of Disease Activity VAS, 4) Patient's Assessment of Disability on Health Assessment Questionnaire Disability Index (HAQ-DI), and 5) Serum high-sensitivity C-reactive protein (serum hs-CRP).
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change In Health Assessment Questionnaire-Disability Index (HAQ-DI) - The HAQ-DI is a self-reported questionnaire of how the patient's illness affects their ability to function in their daily life over the past week.
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response (In The Subset Of Participants With A Body Surface Area [BSA] >= 3% At Baseline) - PASI 90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity.
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) - The percentage of participants who achieve MDA.
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage Of Participants With Resolution Of Enthesitis (Leeds Enthesitis Index [LEI] = 0) In Participants With Enthesitis At Baseline - The LEI will be used to assess the presence or absence of enthesitis.
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Percentage Of Participants With Resolution Of Dactylitis (LDI = 0) In Participants With Dactylitis At Baseline - The LDI will be used to assess the presence or absence of dactylitis.
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Change In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) - The SF-36 is a 36-item, general health, self-administered questionnaire.
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Change In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaire - The FACIT-Fatigue is a 13-item questionnaire that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases.
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Percentage Of Participants Achieving ACR50 Response - ACR50 response is defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Timepoint [8] 0 0
Week 24
Secondary outcome [9] 0 0
Percentage Of Participants Achieving ACR70 Response - ACR70 response is defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).
Timepoint [9] 0 0
Week 24

Eligibility
Key inclusion criteria
- Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening
Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening
Visit.

- Subject has active disease at both Screening Visit and Baseline.

- Diagnosis of active plaque psoriasis.

- Subject has demonstrated an inadequate response or intolerance to biologic
therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs
(csDMARD) therapy(ies).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject is considered by investigator, for any reason, to be an unsuitable candidate
for the study.

- Subject has a known hypersensitivity to risankizumab.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital /ID# 207591 - Garran
Recruitment hospital [2] 0 0
Rheumatology Research Unit /ID# 207191 - Maroochydore
Recruitment hospital [3] 0 0
Griffith University /ID# 207504 - Southport
Recruitment hospital [4] 0 0
Emeritus Research /ID# 207195 - Camberwell
Recruitment hospital [5] 0 0
Monash Health /ID# 208033 - Clayton
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
New Hampshire
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
West Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Argentina
State/province [25] 0 0
Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Ciudad Autonoma Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Rosario, Santa FE
Country [28] 0 0
Argentina
State/province [28] 0 0
San Miguel de Tucuman
Country [29] 0 0
Argentina
State/province [29] 0 0
Santa Fe
Country [30] 0 0
Belgium
State/province [30] 0 0
Oost-Vlaanderen
Country [31] 0 0
Belgium
State/province [31] 0 0
Genk
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Belgium
State/province [33] 0 0
Merksem
Country [34] 0 0
Brazil
State/province [34] 0 0
Goias
Country [35] 0 0
Brazil
State/province [35] 0 0
Rio Grande Do Sul
Country [36] 0 0
Canada
State/province [36] 0 0
British Columbia
Country [37] 0 0
Canada
State/province [37] 0 0
Manitoba
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Denmark
State/province [40] 0 0
Midtjylland
Country [41] 0 0
Denmark
State/province [41] 0 0
Frederiksberg
Country [42] 0 0
Estonia
State/province [42] 0 0
Tartumaa
Country [43] 0 0
Estonia
State/province [43] 0 0
Tallinn
Country [44] 0 0
Finland
State/province [44] 0 0
Kuopio
Country [45] 0 0
Finland
State/province [45] 0 0
Turku
Country [46] 0 0
France
State/province [46] 0 0
Bordeaux
Country [47] 0 0
France
State/province [47] 0 0
Chambray Les Tours
Country [48] 0 0
Germany
State/province [48] 0 0
Nordrhein-Westfalen
Country [49] 0 0
Germany
State/province [49] 0 0
Berlin-buch
Country [50] 0 0
Germany
State/province [50] 0 0
Frankfurt
Country [51] 0 0
Germany
State/province [51] 0 0
Hamburg
Country [52] 0 0
Greece
State/province [52] 0 0
Athens
Country [53] 0 0
Greece
State/province [53] 0 0
Heraklion
Country [54] 0 0
Greece
State/province [54] 0 0
Patras
Country [55] 0 0
Hungary
State/province [55] 0 0
Borsod-Abauj-Zemplen
Country [56] 0 0
Hungary
State/province [56] 0 0
Budapest
Country [57] 0 0
Hungary
State/province [57] 0 0
Szeged
Country [58] 0 0
Hungary
State/province [58] 0 0
Veszprem
Country [59] 0 0
Israel
State/province [59] 0 0
Tel-Aviv
Country [60] 0 0
Israel
State/province [60] 0 0
Ashkelon
Country [61] 0 0
Israel
State/province [61] 0 0
Haifa
Country [62] 0 0
Israel
State/province [62] 0 0
Kfar Saba
Country [63] 0 0
Israel
State/province [63] 0 0
Ramat Gan
Country [64] 0 0
Italy
State/province [64] 0 0
Emilia-Romagna
Country [65] 0 0
Italy
State/province [65] 0 0
Marche
Country [66] 0 0
Italy
State/province [66] 0 0
Verona
Country [67] 0 0
Netherlands
State/province [67] 0 0
Fryslan
Country [68] 0 0
Netherlands
State/province [68] 0 0
Groningen
Country [69] 0 0
Netherlands
State/province [69] 0 0
Leeuwarden
Country [70] 0 0
New Zealand
State/province [70] 0 0
Waikato
Country [71] 0 0
New Zealand
State/province [71] 0 0
Auckland
Country [72] 0 0
New Zealand
State/province [72] 0 0
Burwood Christchurch
Country [73] 0 0
Poland
State/province [73] 0 0
Malopolskie
Country [74] 0 0
Poland
State/province [74] 0 0
Mazowieckie
Country [75] 0 0
Poland
State/province [75] 0 0
Podlaskie
Country [76] 0 0
Poland
State/province [76] 0 0
Pomorskie
Country [77] 0 0
Poland
State/province [77] 0 0
Elblag
Country [78] 0 0
Portugal
State/province [78] 0 0
Lisboa
Country [79] 0 0
Portugal
State/province [79] 0 0
Viana Do Castelo
Country [80] 0 0
Puerto Rico
State/province [80] 0 0
San Juan
Country [81] 0 0
Singapore
State/province [81] 0 0
Singapore
Country [82] 0 0
South Africa
State/province [82] 0 0
Eastern Cape
Country [83] 0 0
South Africa
State/province [83] 0 0
Western Cape
Country [84] 0 0
Spain
State/province [84] 0 0
Barcelona
Country [85] 0 0
Spain
State/province [85] 0 0
Cantabria
Country [86] 0 0
Spain
State/province [86] 0 0
A Coruna
Country [87] 0 0
Spain
State/province [87] 0 0
Madrid
Country [88] 0 0
Spain
State/province [88] 0 0
Valencia
Country [89] 0 0
Sweden
State/province [89] 0 0
Orebro
Country [90] 0 0
Sweden
State/province [90] 0 0
Solna
Country [91] 0 0
Sweden
State/province [91] 0 0
Uppsala
Country [92] 0 0
Sweden
State/province [92] 0 0
Vasteras
Country [93] 0 0
United Kingdom
State/province [93] 0 0
London, City Of
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Manchester
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Portsmouth
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Torquay
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of risankizumab in the
patients with moderately to severely active psoriatic arthritis (PsA).
Trial website
https://clinicaltrials.gov/show/NCT03671148
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications