Clinical trial NCT03219437: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: ABBV-066
BI 655066
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-07-17
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 28.
timeFrame: Week 28
measure: Percentage of participants with a ≥ 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 28
timeFrame: Week 28
Secondary outcomes:
measure: Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28
timeFrame: Week 28
measure: Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28
timeFrame: Week 28
measure: Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28
timeFrame: Week 28
measure: Change from baseline in EQ-5D-5L at all visits collected
timeFrame: Week 28
measure: 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
timeFrame: Week 28
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593
state: Parana
city: Curitiba
country: Brazil
facility: PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401
state: Parana
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento /ID# 208592
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 164565
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743
state: Sao Paulo
city: Campinas
country: Brazil
facility: Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521
state: Sao Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768
state: Sao Paulo
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC /ID# 164519
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto de Dermatologia e Estética do Brasil /ID# 164754
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 164805
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: