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

Study Identifier
M16-176
CT.gov Identifier
NCT03518047
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Plain Language Summary
Available Language(s): English, English, Russian
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
  • risankizumab
  • placebo for rizankizumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    GBUZ Clinical Dermatovenerology Dispensary of MoH of Krasnodar region /ID# 201713
    Krasnodar, Krasnodarskiy Kray, Russian Federation, 350020
    Status
    Not applicable
    Location
    Family Outpatient clinic#4 LLC /ID# 207441
    Korolev, Moscow, Russian Federation, 141060
    Status
    Not applicable
    Location
    SBHI KVD # 10 Clinic of Dermatology and venerology /ID# 200615
    Saint Petersburg, Sankt-Peterburg, Russian Federation, 194021
    Status
    Not applicable
    Location
    LLC ArsVitae Severo-Zapad /ID# 200658
    Saint Petersburg, Sankt-Peterburg, Russian Federation, 194223
    Status
    Not applicable
    Location
    LLC Kurator /ID# 200616
    Saint Petersburg, Sankt-Peterburg, Russian Federation, 196240
    Status
    Not applicable
    Location
    Alliance Biomedical Ural Group /ID# 201681
    Izhevsk, Udmurtiya Republic, Russian Federation, 426061
    Status
    Not applicable