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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03675308




Registration number
NCT03675308
Ethics application status
Date submitted
12/09/2018
Date registered
18/09/2018
Date last updated
18/06/2024

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
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)
Secondary ID [1] 0 0
2017-002465-22
Secondary ID [2] 0 0
M16-011
Universal Trial Number (UTN)
Trial acronym
KEEPsAKE 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 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

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.


Treatment: Other: Placebo
Placebo for risankizumab administered by subcutaneous injection

Treatment: Other: Risankizumab
Risankizumab administered by subcutaneous 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
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
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
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Percentage of Participants With an ACR20 Response at Week 16
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Change From Baseline in Fingernail-Physician Global Assessment (PGA-F)
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Percentage of Participants With Resolution of Enthesitis at Week 24
Timepoint [7] 0 0
Week 24
Secondary outcome [8] 0 0
Percentage of Participants With Resolution of Dactylitis at Week 24
Timepoint [8] 0 0
Week 24
Secondary outcome [9] 0 0
Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Change From Baseline In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Timepoint [10] 0 0
Baseline and Week 24
Secondary outcome [11] 0 0
Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
Timepoint [11] 0 0
Baseline and Week 24
Secondary outcome [12] 0 0
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
Timepoint [12] 0 0
Baseline and Week 24
Secondary outcome [13] 0 0
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
Timepoint [13] 0 0
Baseline and 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 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.
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.
* Participant has previous treatment with biologic agent.

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
25/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/09/2026
Actual
Sample size
Target
Accrual to date
Final
964
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital /ID# 207592 - Garran
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital /ID# 212785 - Herston
Recruitment hospital [3] 0 0
Rheumatology Research Unit Sunshine Coast /ID# 207200 - Maroochydore
Recruitment hospital [4] 0 0
Griffith University /ID# 207505 - Southport
Recruitment hospital [5] 0 0
Flinders Medical Centre /ID# 210562 - Bedford, Park
Recruitment hospital [6] 0 0
Emeritus Research /ID# 207202 - Camberwell
Recruitment hospital [7] 0 0
Monash Medical Centre /ID# 208034 - Clayton
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
4222 - Southport
Recruitment postcode(s) [5] 0 0
5042 - Bedford, Park
Recruitment postcode(s) [6] 0 0
3124 - Camberwell
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment outside Australia
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London, City Of
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Scotland
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Staffordshire
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Manchester
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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 compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).
Trial website
https://clinicaltrials.gov/study/NCT03675308
Trial related presentations / publications
Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Behrens F. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022 Feb;81(2):225-231. doi: 10.1136/annrheumdis-2021-221019. Epub 2021 Dec 15.
Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Soliman AM, Eldred A, Barcomb L, Behrens F. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2023 Jun 1;62(6):2113-2121. doi: 10.1093/rheumatology/keac607.
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.
Kristensen LE, Soliman AM, Papp K, White D, Barcomb L, Lu W, Eldred A, Behrens F. Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis: results of KEEPsAKE 1. Rheumatology (Oxford). 2023 Feb 1;62(2):629-637. doi: 10.1093/rheumatology/keac342.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03675308