Risankizumab Versus Placebo in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment in the Russian Federation (IMMpress)

AbbVie6 sites in 1 country50 target enrollmentJuly 19, 2018

ConditionsPsoriasis

Interventionsplacebo for rizankizumab risankizumab

Drugsrisankizumab placebo for rizankizumab

Overview

Phase: Phase 3
Intervention: placebo for rizankizumab
Conditions: Psoriasis
Sponsor: AbbVie
Enrollment: 50
Locations: 6
Primary Endpoint: Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and efficacy of risankizumab compared to placebo in subjects with moderate to severe chronic plaque psoriasis in the Russian Federation.

Registry

clinicaltrials.gov

Start Date

July 19, 2018

End Date

February 11, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
•Moderate to severe chronic plaque psoriasis at both Screening and Baseline (Randomization) Visits
•Candidates for systemic therapy or phototherapy for psoriasis treatment as assessed by the investigator

Exclusion Criteria

•Prior therapy with an anti-interleukin (IL)-17 or anti-IL12/23p40 or anti-IL-23p19 inhibitor
•Concurrent therapy with a biologic and/or other systemic therapy

Arms & Interventions

Placebo

Placebo for risankizumab by subcutaneous (SC) injection.

Intervention: placebo for rizankizumab

Risankizumab

Risankizumab by subcutaneous (SC) injection.

Intervention: risankizumab

Outcomes

Primary Outcomes

Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16

Time Frame: Week 16

The PASI score is an established measure of clinical efficacy for psoriasis medications.

Secondary Outcomes

Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16(Week 16)
Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16(Week 16)
Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16(Week 16)
Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16(Week 16)