A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Study Identifier
M15-999
CT.gov Identifier
NCT03875482
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Plain Language Summary
Available Language(s): English, Spanish
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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 solution for risankizumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit. * Participant meets following disease activity criteria: * Stable moderate to severe chronic plaque psoriasis, defined as greater than or equal to 10% body surface area (BSA) psoriasis involvement, static physician global assessment (sPGA) score of greater than or equal to 3, and Psoriasis Area Severity Index (PASI) greater than or equal to 12 at Screening and baseline visit. * Candidate for systemic therapy as assessed by the investigator.
    Exclusion Criteria:
    * Participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis. * Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis. * Participant has previous exposure to risankizumab.

    Protocol Summary

    The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Derm Ctr /ID# 210366
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Alliance Dermatology and MOHs /ID# 210645
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    Hull Dermatology, PA /ID# 210305
    Rogers, Arkansas, United States, 72758
    Status
    Not applicable
    Location
    Anaheim Clinical Trials LLC /ID# 212559
    Anaheim, California, United States, 92801-2658
    Status
    Not applicable
    Location
    Wallace Medical Group, Inc. /ID# 210403
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Dermatology Res. Assoc., CA /ID# 210402
    Los Angeles, California, United States, 90045
    Status
    Not applicable
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