Back to resultsA Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
risankizumab
methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring ABBV-066, BI 655066
Eligibility 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
Sites / Locations
- CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593
- PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401
- Hospital Moinhos de Vento /ID# 208592
- Hospital de Clinicas de Porto Alegre /ID# 164565
- Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743
- Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768
- Faculdade de Medicina do ABC /ID# 164519
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723
- Instituto de Dermatologia e Estética do Brasil /ID# 164754
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 164805
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Methotrexate
Risankizumab
Arm Description
Participants to receive double-blind methotrexate.
Participants to receive double-blind risankizumab.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03219437
Brief Title
A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
November 26, 2021 (Actual)
Study Completion Date
November 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
ABBV-066, BI 655066
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methotrexate
Arm Type
Active Comparator
Arm Description
Participants to receive double-blind methotrexate.
Arm Title
Risankizumab
Arm Type
Experimental
Arm Description
Participants to receive double-blind risankizumab.
Intervention Type
Drug
Intervention Name(s)
risankizumab
Other Intervention Name(s)
ABBV-066, BI 655066
Intervention Description
subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
capsule
Primary Outcome Measure Information:
Title
Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28.
Description
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Time Frame
Week 28
Title
Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28
Description
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.
Time Frame
Week 28
Secondary Outcome Measure Information:
Title
Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28
Description
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.
Time Frame
Week 28
Title
Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28
Description
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.
Time Frame
Week 28
Title
Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28
Description
The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Time Frame
Week 28
Title
Change from baseline in EQ-5D-5L at all visits collected
Description
The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life.
Time Frame
Week 28
Title
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
Description
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.
Time Frame
Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80230-130
Country
Brazil
Facility Name
Hospital Moinhos de Vento /ID# 208592
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 164565
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083-888
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Faculdade de Medicina do ABC /ID# 164519
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto de Dermatologia e Estética do Brasil /ID# 164754
City
Rio de Janeiro
ZIP/Postal Code
22470-220
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 164805
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M16-177&Latitude=&Longitude=&LocationName=#additional-resources-section
Description
clinical study report synopsis
Learn more about this trial
A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
We'll reach out to this number within 24 hrs