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

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ClinicalTrials.gov Identifier: NCT03219437
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: risankizumab Drug: methotrexate Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : January 21, 2020
Estimated Study Completion Date : September 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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:
  • ABBV-066
  • BI 655066




Primary Outcome Measures :
  1. Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28. [ Time Frame: Week 28 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  2. Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28 [ Time Frame: 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 :
  1. Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28 [ Time Frame: 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.

  2. Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28 [ Time Frame: 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.

  3. Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28 [ Time Frame: Week 28 ]
    The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219437


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Brazil
Hospital Universitario de brasilia HUB/Ebserh /ID# 164526 Not yet recruiting
Brasília, Distrito Federal, Brazil, 70840-901
PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401 Not yet recruiting
Curitiba, Parana, Brazil, 80230-130
Hospital de Clinicas de Porto Alegre /ID# 164565 Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743 Not yet recruiting
Botucatu, Sao Paulo, Brazil, 18618-686
Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521 Not yet recruiting
Campinas, Sao Paulo, Brazil, 13083-888
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 164768 Not yet recruiting
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Faculdade de Medicina do ABC /ID# 164519 Not yet recruiting
Santo André, Sao Paulo, Brazil, 09060-870
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723 Not yet recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 164805 Not yet recruiting
São Paulo, Sao Paulo, Brazil, 05403-000
Instituto de Dermatologia e Estética do Brasil /ID# 164754 Not yet recruiting
Rio de Janeiro, Brazil, 22470-220
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03219437     History of Changes
Other Study ID Numbers: M16-177
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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

Keywords provided by AbbVie:
ABBV-066
BI 655066

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors