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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)
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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)
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Secondary ID [1]
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2017-002464-40
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Secondary ID [2]
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M15-998
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Universal Trial Number (UTN)
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Trial acronym
KEEPsAKE2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis (PsA)
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [1]
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Change From Baseline In Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [2]
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Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [3]
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Percentage of Participants With an ACR20 Response at Week 16
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Assessment method [3]
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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).
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Timepoint [3]
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Baseline and Week 16
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Secondary outcome [4]
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Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
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Assessment method [4]
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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)
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Timepoint [4]
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Week 24
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Secondary outcome [5]
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Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and Week 24
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Secondary outcome [6]
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Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and Week 24
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Secondary outcome [7]
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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
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Assessment method [7]
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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).
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Timepoint [7]
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Baseline and Week 24
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Secondary outcome [8]
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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
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Assessment method [8]
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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).
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Timepoint [8]
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Baseline and Week 24
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Secondary outcome [9]
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Percentage of Participants With Resolution of Enthesitis at Week 24
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Assessment method [9]
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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).
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Timepoint [9]
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Week 24
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Secondary outcome [10]
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Percentage of Participants With Resolution of Dactylitis at Week 24
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Assessment method [10]
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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.
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Timepoint [10]
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Week 24
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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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
12/06/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
444
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Recruitment in Australia
Recruitment state(s)
ACT,QLD,VIC
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Recruitment hospital [1]
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The Canberra Hospital /ID# 207591 - Garran
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Recruitment hospital [2]
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Rheumatology Research Unit Sunshine Coast /ID# 207191 - Maroochydore
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Recruitment hospital [3]
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Griffith University /ID# 207504 - Southport
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Emeritus Research /ID# 207195 - Camberwell
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Recruitment hospital [5]
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Monash Medical Centre /ID# 208033 - Clayton
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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4558 - Maroochydore
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Recruitment postcode(s) [3]
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4222 - Southport
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Recruitment postcode(s) [4]
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3124 - Camberwell
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment outside Australia
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Spain
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Barcelona
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A Coruna
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Spain
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Madrid
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Spain
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Valencia
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Sweden
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Uppsala
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Sweden
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Vasteras
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United Kingdom
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London, City Of
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Manchester
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United Kingdom
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Torquay
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United Kingdom
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT03671148
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Trial related presentations / 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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/48/NCT03671148/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/48/NCT03671148/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Ostor A, Van den Bosch F, Papp K, Asnal C, Blanco ...
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Results not provided in
https://clinicaltrials.gov/study/NCT03671148