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A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03219437•AbbVie

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

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

Hospital Moinhos de Vento /ID# 208592

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre /ID# 164565

Porto Alegre, Rio Grande do Sul, Brazil

Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743

Botucatu, São Paulo, Brazil

Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521

Campinas, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768

Ribeirão Preto, São Paulo, Brazil

Faculdade de Medicina do ABC /ID# 164519

Santo André, São Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723

São José do Rio Preto, São Paulo, Brazil

Instituto de Dermatologia e Estética do Brasil /ID# 164754

Rio de Janeiro, Brazil

Key Dates

Start Date

July 30, 2018

Primary Completion Date

November 26, 2021

Completion Date

November 26, 2021

Last Updated

November 3, 2022

Enrollment

104

ACTUAL participants

Conditions

Psoriasis

Interventions

risankizumab

DRUG

methotrexate

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments