A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis

Study Identifier
M16-005
CT.gov Identifier
NCT03875508
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
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
    • Study Drug
  • 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 ≥ 10% body surface area (BSA) psoriasis involvement, static Physician Global Assessment (sPGA) score ≥ 3, and Psoriasis Area Severity Index (PASI) ≥ 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 objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (AI), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by AI for the treatment of adult participants with moderate to severe plaque psoriasis.

    Study Locations

    Location
    Status
    Location
    Advanced Research Associates /ID# 210634
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Cognitive Clinical Trials /ID# 210770
    Scottsdale, Arizona, United States, 85258-4446
    Status
    Not applicable
    Location
    Burke Pharmaceutical Research /ID# 211386
    Hot Springs, Arkansas, United States, 71913-6404
    Status
    Not applicable
    Location
    Bakersfield Derma & Skin Cance /ID# 210773
    Bakersfield, California, United States, 93309
    Status
    Not applicable
    Location
    Encino Research Center / T. Jo /ID# 211735
    Encino, California, United States, 91436
    Status
    Not applicable
    Location
    Tien Q Nguyen MD, Inc /ID# 210775
    Fountain Valley, California, United States, 92708-3701
    Status
    Not applicable
    Showing {first} - {last} of {total} Results