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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03671148
Ethics application status
Date submitted
12/09/2018
Date registered
14/09/2018

Titles & IDs
Public title
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)
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
2023-505477-33
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
Treatment: Other - Placebo
Treatment: Other - Risankizumab

Experimental: Risankizumab - Participants 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 comparator: Placebo - Participants 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.


Treatment: Other: Placebo
Placebo for risankizumab administered by subcutaneous (SC) injection

Treatment: Other: Risankizumab
Risankizumab administered by subcutaneous (SC) injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Percentage of Participants With an ACR20 Response at Week 16
Assessment method [3] 0 0
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).
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Assessment method [4] 0 0
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)
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
Assessment method [7] 0 0
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).
Timepoint [7] 0 0
Baseline and Week 24
Secondary outcome [8] 0 0
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
Assessment method [8] 0 0
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).
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
Percentage of Participants With Resolution of Enthesitis at Week 24
Assessment method [9] 0 0
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).
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Percentage of Participants With Resolution of Dactylitis at Week 24
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
Week 24

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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
7/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/06/2026
Actual
Sample size
Target
Accrual to date
Final
444
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 Sunshine Coast /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 Medical Centre /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
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California
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Colorado
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Connecticut
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Georgia
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Illinois
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Louisiana
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Maine
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Maryland
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Massachusetts
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Minnesota
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Missouri
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Madrid
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Solna
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Uppsala
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Vasteras
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Manchester
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Torquay
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Wirral

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

TypeCitations or Other Details
Journal Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03671148