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

Last updated: January 22, 2021
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Rash

Warts

Rosacea

Treatment

N/A

Clinical Study ID

NCT03518047
M16-176
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for atleast 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 bythe investigator

Exclusion

Exclusion Criteria:

  • Prior therapy with an anti-interleukin (IL)-17 or anti-IL12/23p40 or anti-IL-23p19inhibitor
  • Concurrent therapy with a biologic and/or other systemic therapy

Study Design

Total Participants: 50
Study Start date:
July 19, 2018
Estimated Completion Date:
February 11, 2020

Connect with a study center

  • GBUZ Interdisctrict Multidisciplinary Hospital

    Anzorey, Kabardino-Balkarskaya Respublika 361350
    Russian Federation

    Site Not Available

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

    Krasnodar, Krasnodarskiy Kray 350020
    Russian Federation

    Site Not Available

  • Family Outpatient clinic#4 LLC /ID# 207441

    Korolev, Moskva 141060
    Russian Federation

    Site Not Available

  • FSBIH ''Siberian District Medical Centre of FMBA of Russia'' /ID# 201898

    Novosibirsk, Novosibirskaya Oblast 630007
    Russian Federation

    Site Not Available

  • LLC ArsVitae Severo-Zapad /ID# 200658

    Saint-Petersburg, Sankt-Peterburg 194223
    Russian Federation

    Site Not Available

  • LLC Kurator /ID# 200616

    Saint-Petersburg, Sankt-Peterburg 196240
    Russian Federation

    Site Not Available

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

    Saint-Petersburg, Sankt-Peterburg 194021
    Russian Federation

    Site Not Available

  • City Clinical Hospital #7 /ID# 200610

    Kazan, Tatarstan, Respublika 420103
    Russian Federation

    Site Not Available

  • Alliance Biomedical Ural Group /ID# 201681

    Izhevsk, Udmurtskaya Respublika 426061
    Russian Federation

    Site Not Available

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