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

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 Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: risankizumab; Drug: methotrexate

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22470-220
    • Instituto de Dermatologia e Estética do Brasil /ID# 164754
  • Sao Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 164805
  • Parana
    • Curitiba, Parana, Brazil, 80030-110
      • CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593
    • Curitiba, Parana, Brazil, 80230-130
      • PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
      • Hospital Moinhos de Vento /ID# 208592
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre /ID# 164565
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618-686
      • Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743
    • Campinas, Sao Paulo, Brazil, 13083-888
      • Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521
    • Ribeirão Preto, Sao Paulo, Brazil, 14051-140
      • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768
    • Santo André, Sao Paulo, Brazil, 09060-870
      • Faculdade de Medicina do ABC /ID# 164519
    • Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
      • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Methotrexate; Participants to receive double-blind methotrexate.	Drug: methotrexate; capsule
EXPERIMENTAL: Risankizumab; Participants to receive double-blind risankizumab.	Drug: risankizumab; subcutaneous (SC) injection; Other Names: BI 655066; ABBV-066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2018
• Primary Completion (ACTUAL): November 26, 2021
• Study Completion (ACTUAL): November 26, 2021

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (ACTUAL): July 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ABBV-066; BI 655066
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID Numbers: M16-177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No