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A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219437
Recruitment Status : Active, not recruiting
First Posted : July 17, 2017
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE July 14, 2017
First Posted Date  ICMJE July 17, 2017
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE July 30, 2018
Estimated Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
  • Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28. [ Time Frame: Week 28 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
  • Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28 [ Time Frame: Week 28 ]
    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 of erythema, induration, and scale, weighted by body part.
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
  • Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28 [ Time Frame: Week 28 ]
    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 of erythema, induration, and scale, weighted by body part.
  • Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28. [ Time Frame: Week 28 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Change History Complete list of historical versions of study NCT03219437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28 [ Time Frame: Week 28 ]
    PASI100 denotes greater than or equal to 100% 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 of erythema, induration, and scale, weighted by body part.
  • Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28 [ Time Frame: Week 28 ]
    PASI75 denotes greater than or equal to 75% 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 of erythema, induration, and scale, weighted by body part.
  • Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28 [ Time Frame: Week 28 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
  • Change from baseline in EQ-5D-5L at all visits collected [ Time Frame: Week 28 ]
    The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life.
  • Achievement of an increase of 0.1 or more points from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) at all visits [ Time Frame: Week 28 ]
    The EQ‐5D‐5L has five dimensions: mobility, self‐care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five‐level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2017)
  • Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28 [ Time Frame: Week 28 ]
    PASI100 denotes greater than or equal to 100% 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 of erythema, induration, and scale, weighted by body part.
  • Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28 [ Time Frame: Week 28 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
  • Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28 [ Time Frame: Week 28 ]
    PASI75 denotes greater than or equal to 75% 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 of erythema, induration, and scale, weighted by body part.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: risankizumab
    subcutaneous (SC) injection
    Other Names:
    • ABBV-066
    • BI 655066
  • Drug: methotrexate
    capsule
Study Arms  ICMJE
  • Active Comparator: Methotrexate
    Participants to receive double-blind methotrexate.
    Intervention: Drug: methotrexate
  • Experimental: Risankizumab
    Participants to receive double-blind risankizumab.
    Intervention: Drug: risankizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 15, 2019)
104
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2017)
100
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of plaque psoriasis (with or without concurrent psoriatic arthritis) for at least 6 months before the first administration of study drug
  • Have stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline Visits
  • Be a candidate for systemic therapy for plaque psoriasis as assessed by the investigator
  • Be a candidate for treatment with methotrexate (MTX) according to local label

Exclusion Criteria:

  • Subjects with non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment
  • Previous exposure to risankizumab
  • Previous exposure to MTX
  • Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator
  • Subject has a history of clinically significant hematologic, renal, or liver disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03219437
Other Study ID Numbers  ICMJE M16-177
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP