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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03219437
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

AbbVie Inc.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Brazil
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Curitiba, Parana, Brazil

Status

Recruiting

Address

Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 208593

Curitiba, Parana, 80030-110

Curitiba, Parana, Brazil

Status

Recruiting

Address

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

Curitiba, Parana, 80230-130

Porto Alegre, Rio Grande Do Sul, Brazil

Status

Recruiting

Address

Instituto de Educação e Pesquisa do Hospital Moinhos de Vento /ID# 208592

Porto Alegre, Rio Grande Do Sul, 90035-001

Porto Alegre, Rio Grande Do Sul, Brazil

Status

Recruiting

Address

Hospital de Clinicas de Porto Alegre /ID# 164565

Porto Alegre, Rio Grande Do Sul, 90035-903

Botucatu, Sao Paulo, Brazil

Status

Recruiting

Address

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

Botucatu, Sao Paulo, 18618-686

Campinas, Sao Paulo, Brazil

Status

Recruiting

Address

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

Campinas, Sao Paulo, 13083-888

Ribeirão Preto, Sao Paulo, Brazil

Status

Recruiting

Address

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

Ribeirão Preto, Sao Paulo, 14048-900

Faculdade de Medicina do ABC /ID# 164519, Santo André, Sao Paulo, Brazil

Status

Recruiting

Address

Faculdade de Medicina do ABC /ID# 164519

Santo André, Sao Paulo, 09060-870

Sao Jose Do Rio Preto, Sao Paulo, Brazil

Status

Recruiting

Address

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

Sao Jose Do Rio Preto, Sao Paulo, 15090-000

São Paulo, Sao Paulo, Brazil

Status

Recruiting

Address

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 164805

São Paulo, Sao Paulo, 05403-000

Rio de Janeiro, Brazil

Status

Recruiting

Address

Instituto de Dermatologia e Estética do Brasil /ID# 164754

Rio de Janeiro, , 22470-220

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