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

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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

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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