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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
risankizumab
placebo for rizankizumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713
  • Family Outpatient clinic#4 LLC /ID# 207441
  • SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615
  • LLC ArsVitae Severo-Zapad /ID# 200658
  • LLC Kurator /ID# 200616
  • Alliance Biomedical Ural Group /ID# 201681

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Risankizumab

Arm Description

Placebo for risankizumab by subcutaneous (SC) injection.

Risankizumab by subcutaneous (SC) injection.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2018
Last Updated
January 22, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03518047
Brief Title
Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation
Acronym
IMMPRESS
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
February 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for risankizumab by subcutaneous (SC) injection.
Arm Title
Risankizumab
Arm Type
Experimental
Arm Description
Risankizumab by subcutaneous (SC) injection.
Intervention Type
Drug
Intervention Name(s)
risankizumab
Other Intervention Name(s)
ABBV-066, BI 655066
Intervention Description
rizankizumab subcutaneous (SC) infusion
Intervention Type
Drug
Intervention Name(s)
placebo for rizankizumab
Intervention Description
placebo for rizankizumab subcutaneous (SC) infusion
Primary Outcome Measure Information:
Title
Proportion of participants with a 90% reduction from Baseline Psoriasis Area and Severity Index (PASI 90) at Week 16
Description
The PASI score is an established measure of clinical efficacy for psoriasis medications.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Proportion of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear (0, 1) at Week 16
Description
The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.
Time Frame
Week 16
Title
Proportion of participants with a 75% reduction from Baseline Psoriasis Area and Severity Index (PASI 75) at Week 16
Description
The PASI score is an established measure of clinical efficacy for psoriasis medications.
Time Frame
Week 16
Title
Proportion of participants with a 100% reduction from Baseline Psoriasis Area and Severity Index (PASI 100) at Week 16
Description
The PASI score is an established measure of clinical efficacy for psoriasis medications.
Time Frame
Week 16
Title
Proportion of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
Description
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).
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713
City
Krasnodar
State/Province
Krasnodarskiy Kray
ZIP/Postal Code
350020
Country
Russian Federation
Facility Name
Family Outpatient clinic#4 LLC /ID# 207441
City
Korolev
State/Province
Moskva
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194021
Country
Russian Federation
Facility Name
LLC ArsVitae Severo-Zapad /ID# 200658
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194223
Country
Russian Federation
Facility Name
LLC Kurator /ID# 200616
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
196240
Country
Russian Federation
Facility Name
Alliance Biomedical Ural Group /ID# 201681
City
Izhevsk
State/Province
Udmurtskaya Respublika
ZIP/Postal Code
426061
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
35917057
Citation
Odnopozova L, Edin A, Sukharev A, Wu T, Aydin K, Kelly M, Khotko A. Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis in the Russian Federation. Dermatol Ther (Heidelb). 2022 Sep;12(9):2063-2075. doi: 10.1007/s13555-022-00776-0. Epub 2022 Aug 2.
Results Reference
derived
Links:
URL
https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/risankizumab_M16-176.pdf
Description
clinical study report synopsis

Learn more about this trial

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

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