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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2020-02-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo for risankizumab by subcutaneous (SC) injection.

Group Type PLACEBO_COMPARATOR

placebo for rizankizumab

Intervention Type DRUG

placebo for rizankizumab subcutaneous (SC) infusion

Risankizumab

Risankizumab by subcutaneous (SC) injection.

Group Type EXPERIMENTAL

risankizumab

Intervention Type DRUG

rizankizumab subcutaneous (SC) infusion

Interventions

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risankizumab

rizankizumab subcutaneous (SC) infusion

Intervention Type DRUG

placebo for rizankizumab

placebo for rizankizumab subcutaneous (SC) infusion

Intervention Type DRUG

Other Intervention Names

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ABBV-066 BI 655066

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No