NCT03219437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2018

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2021

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

3.3 years

First QC Date

July 14, 2017

Last Update Submit

November 1, 2022

Conditions

Psoriasis

Keywords

ABBV-066BI 655066

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Percentage of participants with a 100% reduction from Baseline PASI score (PASI 100) at Week 28

    Week 28

  • Percentage of participants with a ≥ 75% reduction from Baseline PASI score (PASI 75) at Week 28

    Week 28

  • Percentage of participants with Static Physician Global Assessment (sPGA) score of clear (0) at Week 28

    Week 28

  • Change from baseline in EQ-5D-5L at all visits collected

    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

    Week 28

Study Arms (2)

Methotrexate

ACTIVE COMPARATOR

Participants to receive double-blind methotrexate.

Drug: methotrexate

Risankizumab

EXPERIMENTAL

Participants to receive double-blind risankizumab.

Drug: risankizumab

Interventions

risankizumabDRUG

subcutaneous (SC) injection

Also known as: ABBV-066, BI 655066
Risankizumab
methotrexateDRUG

capsule

Methotrexate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593

Curitiba, Paraná, 80030-110, Brazil

Location

PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401

Curitiba, Paraná, 80230-130, Brazil

Location

Hospital Moinhos de Vento /ID# 208592

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Hospital de Clinicas de Porto Alegre /ID# 164565

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743

Botucatu, São Paulo, 18618-686, Brazil

Location

Hospital de Clinicas da Universidade Estadual de Campinas - UNICAMP /ID# 164521

Campinas, São Paulo, 13083-888, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 164768

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Faculdade de Medicina do ABC /ID# 164519

Santo André, São Paulo, 09060-870, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 164723

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Instituto de Dermatologia e Estética do Brasil /ID# 164754

Rio de Janeiro, 22470-220, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 164805

São Paulo, 05403-000, Brazil

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

risankizumabMethotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 17, 2017

Study Start

July 30, 2018

Primary Completion

November 26, 2021

Study Completion

November 26, 2021

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
More information

Locations

BR(11)