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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: placebo for rizankizumab; Drug: risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03518047

M16-176

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo for risankizumab by subcutaneous (SC) injection.

Treatment:

Drug: placebo for rizankizumab

Risankizumab

Experimental group

Description:

Risankizumab by subcutaneous (SC) injection.

Treatment:

Drug: risankizumab