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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) (KEEPsAKE2)

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ClinicalTrials.gov Identifier: NCT03671148
Recruitment Status : Active, not recruiting
First Posted : September 14, 2018
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of risankizumab in the patients with moderately to severely active psoriatic arthritis (PsA).

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis (PsA) Biological: placebo for rizankizumab Biological: risankizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : March 7, 2019
Actual Primary Completion Date : June 22, 2020
Estimated Study Completion Date : May 17, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Risankizumab
Participants randomized to receive double-blind risankizumab for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).
 Biological: risankizumab
Risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI
Placebo Comparator: Placebo
Participants randomized to receive double-blind placebo for 24 weeks (Period 1) followed by open-label risankizumab for 184 weeks (Period 2).
 Biological: placebo for rizankizumab
Placebo for risankizumab administered by subcutaneous (SC) injection

Biological: risankizumab
Risankizumab administered by subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066
  • SKYRIZI


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving at least 20% Improvement in American College of Rheumatology (ACR20) [ Time Frame: Week 24 ]
    ACR20 is defined as at least 20% improvement in swollen joint count, tender joint count, and at least 3 out of the following 5 variables: 1) Patient's Assessment of psoriatic arthritis (PsA) Pain Intensity visual analog scale (VAS), 2) Patient's Global Assessment of Disease VAS, 3) Physician's Global Assessment of Disease Activity VAS, 4) Patient's Assessment of Disability on Health Assessment Questionnaire Disability Index (HAQ-DI), and 5) Serum high-sensitivity C-reactive protein (serum hs-CRP).


Secondary Outcome Measures :
  1. Change In Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Week 24 ]
    The HAQ-DI is a self-reported questionnaire of how the patient's illness affects their ability to function in their daily life over the past week.

  2. Percentage Of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response (In The Subset Of Participants With A Body Surface Area [BSA] >= 3% At Baseline) [ Time Frame: Week 24 ]
    PASI 90 denotes greater than or equal to 90% improvement in PASI score. PASI provides a quantitative assessment of psoriasis disease state based on the amount of body surface area that is affected and the degree of severity.

  3. Percentage of Participants Achieving ACR20 [ Time Frame: Week 16 ]
    ACR20 is defined as at least 20% improvement in swollen joint count, tender joint count, and at least 3 out of the following 5 variables: 1) Patient's Assessment of psoriatic arthritis (PsA) Pain Intensity visual analog scale (VAS), 2) Patient's Global Assessment of Disease VAS, 3) Physician's Global Assessment of Disease Activity VAS, 4) Patient's Assessment of Disability on Health Assessment Questionnaire Disability Index (HAQ-DI), and 5) Serum high-sensitivity C-reactive protein (serum hs-CRP).

  4. Percentage of Participants Achieving Minimal Disease Activity (MDA) [ Time Frame: Week 24 ]
    The percentage of participants who achieve MDA.

  5. Change In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) [ Time Frame: Week 24 ]
    The SF-36 is a 36-item, general health, self-administered questionnaire.

  6. Change In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaire [ Time Frame: Week 24 ]
    The FACIT-Fatigue is a 13-item questionnaire that evaluates fatigue/tiredness and its impact on daily activities and functioning in chronic diseases.

  7. Percentage Of Participants Achieving at least 50% Improvement in American College of Rheumatology (ACR50) Response [ Time Frame: Week 24 ]
    ACR50 response is defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).

  8. Percentage Of Participants Achieving at least 70% Improvement in American College of Rheumatology (ACR70) Response [ Time Frame: Week 24 ]
    ACR70 response is defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).

  9. Percentage Of Participants With Resolution Of Enthesitis (Leeds Enthesitis Index [LEI] = 0) In Participants With Enthesitis At Baseline [ Time Frame: Week 24 ]
    The LEI will be used to assess the presence or absence of enthesitis.

  10. Percentage Of Participants With Resolution Of Dactylitis (Leeds Dactylitis Index [LDI] = 0) In Participants With Dactylitis At Baseline [ Time Frame: Week 24 ]
    The LDI will be used to assess the presence or absence of dactylitis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit.
  • Participant has active disease at both Screening Visit and Baseline.
  • Diagnosis of active plaque psoriasis.
  • Participant has demonstrated an inadequate response or intolerance to biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671148


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03671148    
Other Study ID Numbers: M15-998
2017-002464-40 ( EudraCT Number )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: 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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
KEEPsAKE 2
Risankizumab
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
 Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases