Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03518047

Acronym

IMMPRESS

Enrollment

Registered

2018-05-08

Start date

2018-07-19

Completion date

2020-02-11

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Plaque Psoriasis

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.

Interventions

DRUGrisankizumab

rizankizumab subcutaneous (SC) infusion

DRUGplacebo for rizankizumab

placebo for rizankizumab subcutaneous (SC) infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16	Week 16	The PASI score is an established measure of clinical efficacy for psoriasis medications.

Secondary

Measure	Time frame	Description
Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16	Week 16	The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16	Week 16	The PASI score is an established measure of clinical efficacy for psoriasis medications.
Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16	Week 16	The PASI score is an established measure of clinical efficacy for psoriasis medications.
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16	Week 16	The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much).

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026