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

AbbVie50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Psoriasis

Interventions

risankizumabDRUG

rizankizumab subcutaneous (SC) infusion

placebo for rizankizumabDRUG

placebo for rizankizumab subcutaneous (SC) infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713

Krasnodar, Krasnodarskiy Kray, Russia

Family Outpatient clinic#4 LLC /ID# 207441

Korolev, Moscow, Russia

SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615

Saint Petersburg, Sankt-Peterburg, Russia

LLC ArsVitae Severo-Zapad /ID# 200658

Saint Petersburg, Sankt-Peterburg, Russia

Outcomes

Primary Outcomes

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.

Time frame: Week 16

Secondary Outcomes

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.

Time frame: Week 16

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.

Time frame: Week 16

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.

Time frame: Week 16

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).

Time frame: Week 16

Data from ClinicalTrials.gov

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