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Completed

NCT Number: NCT03219437

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

The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593, Curitiba, Paraná, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risankizumab

Drug

subcutaneous (SC) injection

Other names: ABBV-066, BI 655066

methotrexate

Drug

capsule

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2017
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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