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

AbbVie

Status and phase

Completed

Phase 3

Conditions

Psoriasis

Treatments

Drug: risankizumab

Drug: methotrexate

Study type

Interventional

Funder types

Industry

Identifiers

NCT03219437

M16-177

Details and patient eligibility

About

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

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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