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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03675308
Registration number
NCT03675308
Ethics application status
Date submitted
12/09/2018
Date registered
18/09/2018
Date last updated
11/05/2023
Titles & IDs
Public title
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
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Scientific title
A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)
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Secondary ID [1]
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2017-002465-22
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Secondary ID [2]
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M16-011
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Universal Trial Number (UTN)
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Trial acronym
KEEPsAKE 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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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
Other interventions - Placebo
Other interventions - Risankizumab
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.
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.
Other interventions: Placebo
Placebo for risankizumab administered by subcutaneous injection
Other interventions: Risankizumab
Risankizumab administered by subcutaneous injection
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Intervention code [1]
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Other interventions
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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:
= 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).
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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:
= 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).
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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 Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24
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Assessment method [5]
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The investigator assessed each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail), pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (> 50 pits present), and nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling) and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula.
The mNAPSI score is calculated as the sum of all the components for all of the participant's fingernails giving a range of possible scores from 0 (absence of nail psoriasis) to 130 (the most severe nail psoriasis). A negative change from Baseline 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 Fingernail-Physician Global Assessment (PGA-F)
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Assessment method [6]
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The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms associated with fingernail psoriasis. Participant's fingernails were assessed separately for nail bed signs and nail matrix signs of disease on a scale from 0 (clear) to 4 (severe). A participant's overall global score is the worse of the nail bed score and nail matrix score. For example, if a participant had a nail bed score '2' and a nail matrix score of '4,' this participant's overall score was '4.' A negative 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 Resolution of Enthesitis at Week 24
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Assessment method [7]
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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).
To increase the sample size due to the smaller number of participants with enthesitis at Baseline, the pre-specified analysis of the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Percentage of Participants With Resolution of Dactylitis at Week 24
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Assessment method [8]
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Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.
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.
To increase sample size due to the smaller number of participants with dactylitis at Baseline, the pre-specified analysis of the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).
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Timepoint [8]
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Week 24
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Secondary outcome [9]
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Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24
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Assessment method [9]
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The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers.
Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst).
Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst).
Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN.
The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst).
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Timepoint [9]
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Baseline and Week 24
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Secondary outcome [10]
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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 [10]
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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 [10]
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Baseline and Week 24
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Secondary outcome [11]
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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 [11]
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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 [11]
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Baseline and Week 24
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Secondary outcome [12]
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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 [12]
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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).
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Timepoint [12]
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Baseline and Week 24
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Secondary outcome [13]
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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 [13]
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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).
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Timepoint [13]
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Baseline and Week 24
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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 the Screening
Visit.
- Participant has active disease at Baseline defined as = 5 tender joints (based on 68
joint counts) and = 5 swollen joints (based on 66 joint counts)
- 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 or
contraindication for conventional synthetic disease modifying anti-rheumatic drugs
(csDMARD) therapy(ies).
- Presence of either at Screening:
- = 1 erosion on radiograph as determined by central imaging review or;
- High sensitivity C-reactive protein (hsCRP) = 3.0 mg/L.
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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.
- Participant has previous treatment with biologic agent.
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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
25/03/2019
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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
28/09/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
964
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Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC
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Recruitment hospital [1]
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The Canberra Hospital /ID# 207592 - Garran
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital /ID# 212785 - Herston
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Rheumatology Research Unit Sunshine Coast /ID# 207200 - Maroochydore
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Griffith University /ID# 207505 - Southport
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Flinders Medical Centre /ID# 210562 - Bedford, Park
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Emeritus Research /ID# 207202 - Camberwell
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Monash Medical Centre /ID# 208034 - Clayton
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2605 - Garran
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4029 - Herston
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4558 - Maroochydore
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4222 - Southport
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5042 - Bedford, Park
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3124 - Camberwell
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Recruitment postcode(s) [7]
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3168 - Clayton
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Recruitment outside Australia
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Alabama
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Vitacura Santiago
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Praha
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Uherske Hradiste
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Hovedstaden
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Denmark
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Harjumaa
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Estonia
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Tartumaa
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Finland
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Uusimaa
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Finland
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Kuopio
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Finland
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Germany
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Germany
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Germany
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Attiki
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Kriti
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Country [72]
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Greece
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Thessaloniki
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Greece
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Athens
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Greece
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Patras
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Israel
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Tel-Aviv
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Israel
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Ashkelon
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Country [77]
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Israel
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Haifa
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Country [78]
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Israel
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Kfar Saba
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Country [79]
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Israel
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Petakh Tikva
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Italy
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Emilia-Romagna
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Italy
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Ancona
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Italy
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Catania
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Italy
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Italy
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Verona
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Seoul Teugbyeolsi
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Korea, Republic of
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Daegu
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Adazi
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Latvia
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Liepaja
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Latvia
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Riga
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Klaipeda
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Lithuania
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Siauliai
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Negeri Sembilan
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Perak
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Selangor
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Ciudad De Mexico
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Yucatan
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Country [101]
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Mexico
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Ciudad de Mexico
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Mexico
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Mexico City
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Fryslan
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Country [104]
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Netherlands
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Groningen
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Country [105]
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Netherlands
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Leeuwarden
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Country [106]
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Auckland
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Country [107]
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New Zealand
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Waikato
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Country [108]
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New Zealand
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Burwood
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Country [109]
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Poland
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Kujawsko-pomorskie
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Poland
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Malopolskie
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Poland
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Mazowieckie
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Country [112]
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Poland
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Podlaskie
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Country [113]
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Poland
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Warminsko-mazurskie
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Country [114]
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Portugal
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State/province [114]
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Porto
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Country [115]
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Portugal
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Viana Do Castelo
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Country [116]
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Portugal
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Aveiro
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Country [117]
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Portugal
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Braga
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Country [118]
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Portugal
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Lisboa
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Puerto Rico
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San Juan
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Country [120]
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Romania
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Timis
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Iasi
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Country [124]
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Russian Federation
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Moskva
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Russian Federation
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Novosibirskaya Oblast
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Russian Federation
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Russian Federation
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Tatarstan, Respublika
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Russian Federation
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Moscow
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Country [129]
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Russian Federation
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Perm
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Country [130]
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Russian Federation
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Ulyanovsk
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Country [131]
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Serbia
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Beograd
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Country [132]
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Serbia
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Country [133]
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Singapore
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Singapore
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Slovakia
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Biely Kostol
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Country [135]
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Slovakia
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Martin
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Country [136]
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Slovakia
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State/province [136]
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Nove Mesto nad Vahom
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Country [137]
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Slovakia
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Piestany
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Country [138]
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Slovakia
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Poprad
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Country [139]
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South Africa
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Eastern Cape
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Country [140]
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South Africa
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Gauteng
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Country [141]
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South Africa
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Western Cape
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Country [142]
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Spain
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Barcelona
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Country [143]
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Spain
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A Coruna
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Country [144]
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Spain
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Almeria
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Country [145]
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Spain
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Madrid
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Country [146]
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Spain
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Valencia
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Country [147]
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Sweden
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Orebro Lan
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Country [148]
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Sweden
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Skane Lan
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Country [149]
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Sweden
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Falun
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Country [150]
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Sweden
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Solna
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Country [151]
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Sweden
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Uppsala
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Country [152]
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Sweden
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Vasteras
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Taiwan
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Chia-Yi
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Country [154]
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Taiwan
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Taichung
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Taiwan
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Taoyuan City
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Country [156]
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Ukraine
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State/province [156]
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Kharkivska Oblast
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Country [157]
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Ukraine
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State/province [157]
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Vinnytska Oblast
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Country [158]
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Ukraine
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State/province [158]
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Cherkasy
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Country [159]
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Ukraine
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Chernihiv
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Country [160]
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Ukraine
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Kharkiv
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Country [161]
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Ukraine
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Khmelnytskyi
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Country [162]
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Ukraine
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Kryvyi Rih
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Country [163]
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Ukraine
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Kyiv
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Country [164]
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Ukraine
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Lutsk
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Country [165]
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Ukraine
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Lviv
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Country [166]
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Ukraine
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Poltava
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Country [167]
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Ukraine
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Zaporizhzhia
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Country [168]
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0
United Kingdom
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London, City Of
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Country [169]
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United Kingdom
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Scotland
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Country [170]
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United Kingdom
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Staffordshire
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Country [171]
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United Kingdom
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Manchester
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Country [172]
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United Kingdom
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Portsmouth
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Country [173]
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United Kingdom
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Torquay
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Country [174]
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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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Address
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Country
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Ethics approval
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Summary
Brief summary
The purpose of this study is to compare the safety and efficacy of risankizumab versus
placebo in participants with moderately to severely active psoriatic arthritis (PsA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03675308
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
ABBVIE INC.
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Address
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03675308
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