ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03518047
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: risankizumab Drug: placebo for risankizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo for risankizumab by subcutaneous (SC) injection.
Drug: placebo for risankizumab
placebo for risankizumab subcutaneous (SC) infusion

Experimental: Risankizumab
Risankizumab by subcutaneous (SC) injection.
Drug: risankizumab
risankizumab subcutaneous (SC) infusion
Other Names:
  • ABBV-066
  • BI 655066




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518047


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Russian Federation
GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713 Recruiting
Krasnodar, Krasnodarskiy Kray, Russian Federation, 350020
SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615 Recruiting
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 194021
LLC ArsVitae Severo-Zapad /ID# 200658 Recruiting
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 194223
LLC Kurator /ID# 200616 Recruiting
Saint-Petersburg, Sankt-Peterburg, Russian Federation, 196240
Family Outpatient clinic#4,LLC /ID# 207441 Not yet recruiting
Korolev, Tatarstan, Respublika, Russian Federation, 141060
Alliance Biomedical Ural Group /ID# 201681 Recruiting
Izhevsk, Udmurtskaya Respublika, Russian Federation, 426061
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03518047     History of Changes
Other Study ID Numbers: M16-176
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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

Keywords provided by AbbVie:
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases