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Completed

NCT Number: NCT03518047

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713, Krasnodar, Krasnodarskiy Kray, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risankizumab

Drug

rizankizumab subcutaneous (SC) infusion

Other names: ABBV-066, BI 655066

placebo for rizankizumab

Drug

placebo for rizankizumab subcutaneous (SC) infusion

Primary outcomes

  1. 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

  1. Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16

    Time frame: Week 16

    The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.

  2. Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16

    Time frame: Week 16

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

  3. Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16

    Time frame: Week 16

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

  4. Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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)

Acronym: IMMPRESS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 8, 2018
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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