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

Phase 3CompletedNCT03219437

AbbVie104 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

104

Conditions

Psoriasis

Interventions

risankizumabDRUG

subcutaneous (SC) injection

methotrexateDRUG

capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593

Curitiba, Paraná, Brazil

PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401

Curitiba, Paraná, Brazil

Outcomes

Primary Outcomes

Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28.

The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

Time frame: Week 28

Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at 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.

Time frame: Week 28

Secondary Outcomes

Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at 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.

Time frame: Week 28

Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at 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.

Time frame: Week 28

Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28

The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

Time frame: Week 28

Data from ClinicalTrials.gov

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