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

Psoriasis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219437
• Other study ID #: M16-177
• Status: Completed
• Phase: Phase 3
• Start date: July 30, 2018
• Est. completion date: November 26, 2021

Study information

• Verified date: November 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 26, 2021
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• risankizumab
subcutaneous (SC) injection
• methotrexate
capsule

Locations

Country	Name	City	State
Brazil	Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743	Botucatu	Sao Paulo
Brazil	Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521	Campinas	Sao Paulo
Brazil	CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593	Curitiba	Parana
Brazil	PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401	Curitiba	Parana
Brazil	Hospital de Clinicas de Porto Alegre /ID# 164565	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento /ID# 208592	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768	Ribeirão Preto	Sao Paulo
Brazil	Instituto de Dermatologia e Estética do Brasil /ID# 164754	Rio de Janeiro
Brazil	Faculdade de Medicina do ABC /ID# 164519	Santo André	Sao Paulo
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723	Sao Jose Do Rio Preto	Sao Paulo
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 164805	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 28
Primary	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.	Week 28
Secondary	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.	Week 28
Secondary	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.	Week 28
Secondary	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.	Week 28
Secondary	Change from baseline in EQ-5D-5L at all visits collected	The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life.	Week 28
Secondary	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	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.	Week 28

External Links

•   clinical study report synopsis