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

January 22, 2021 updated by: AbbVie

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Krasnodarskiy Kray
      • Krasnodar, Krasnodarskiy Kray, Russian Federation, 350020
        • GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713
    • Moskva
      • Korolev, Moskva, Russian Federation, 141060
        • Family Outpatient clinic#4 LLC /ID# 207441
    • Sankt-Peterburg
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 194021
        • SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 194223
        • LLC ArsVitae Severo-Zapad /ID# 200658
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 196240
        • LLC Kurator /ID# 200616
    • Udmurtskaya Respublika
      • Izhevsk, Udmurtskaya Respublika, Russian Federation, 426061
        • Alliance Biomedical Ural Group /ID# 201681

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo for risankizumab by subcutaneous (SC) injection.
Drug: placebo for rizankizumab
placebo for rizankizumab subcutaneous (SC) infusion
Experimental: Risankizumab
Risankizumab by subcutaneous (SC) injection.
Drug: risankizumab
rizankizumab subcutaneous (SC) infusion
Other Names:
  • BI 655066
  • ABBV-066

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 16
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.
Week 16
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.
Week 16
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).
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2018

Primary Completion (Actual)

February 11, 2020

Study Completion (Actual)

February 11, 2020

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M16-176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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