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

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: risankizumab; Drug: placebo for rizankizumab

• Registration Number: NCT03518047
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-08
• Study Start: 2018-07-19
• Primary Completion: 2020-02-11
• Study Completion: 2020-02-11
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risankizumab	risankizumab	Risankizumab by subcutaneous (SC) injection.
Placebo	placebo for rizankizumab	Placebo for risankizumab by subcutaneous (SC) injection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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 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 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.

Trial Locations

Locations (6)

GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713; 🇷🇺 Krasnodar, Krasnodarskiy Kray, Russian Federation

LLC Kurator /ID# 200616; 🇷🇺 Saint-Petersburg, Sankt-Peterburg, Russian Federation

Alliance Biomedical Ural Group /ID# 201681; 🇷🇺 Izhevsk, Udmurtskaya Respublika, Russian Federation

SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615; 🇷🇺 Saint-Petersburg, Sankt-Peterburg, Russian Federation

Family Outpatient clinic#4 LLC /ID# 207441; 🇷🇺 Korolev, Moskva, Russian Federation

LLC ArsVitae Severo-Zapad /ID# 200658; 🇷🇺 Saint-Petersburg, Sankt-Peterburg, Russian Federation