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A 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

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ClinicalTrials.gov Identifier: NCT03675308
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in subjects with moderately to severely active psoriatic arthritis (PsA).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 880 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 (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
Estimated Study Start Date : December 20, 2018
Estimated Primary Completion Date : January 8, 2021
Estimated Study Completion Date : December 6, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Percentage of Participants Achieving at least 20% Improvement in American College of Rheumatology (ACR20) at Week 24 [ Time Frame: Baseline, 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 from Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, 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 With ≥ 90% Reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 24 in Participants With ≥ 3% Body Surface Area (BSA) Involving Psoriasis at Baseline [ Time Frame: Baseline, Week 24 ]
    PASI90 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. Change from Baseline to Week 24 in modified Total Sharp Score (PsA-mTSS) at Week 24 [ Time Frame: Baseline, Week 24 ]
    The modified PsA-mTSS method is used to evaluate radiographic evidence of damage.

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

  5. Change from Baseline to Week 24 in Fingernail Psoriasis [ Time Frame: Baseline, Week 24 ]
    Fingernail psoriasis will be evaluated using either the Physician Global Assessment - Fingernails (PGA-F) or the modified Nail Psoriasis Severity Index (mNAPSI), depending on location.

  6. Change from Baseline to Week 24 in Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline [ Time Frame: Baseline, Week 24 ]
    The LEI will be used to assess the presence or absence of enthesitis.

  7. Change from Baseline to Week 24 in Leeds Dactylitis Index (LDI) in Participants With Dactylitis at Baseline [ Time Frame: Baseline, Week 24 ]
    The LDI will be used to assess the presence or absence of dactylitis.

  8. Change from Baseline to Week 24 in the 36-Item Short Form Health Questionnaire (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Baseline, Week 24 ]
    The SF-36 is a 36-item, general health, self-administered questionnaire.

  9. Change from Baseline to Week 24 in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaire Score [ Time Frame: Baseline, 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.



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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 the Screening Visit.
  • Subject has active disease at Baseline
  • Diagnosis of active plaque psoriasis.
  • Subject has demonstrated an inadequate response or intolerance to conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).

Exclusion Criteria:

  • Subject is considered by investigator, for any reason, to be an unsuitable candidate for the study.
  • Subject has a known hypersensitivity to risankizumab.
  • Subject has previous treatment with biologic agent.

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): NCT03675308


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03675308     History of Changes
Other Study ID Numbers: M16-011
2017-002465-22 ( EudraCT Number )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
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

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antirheumatic Agents