A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab

Study Identifier
M19-164
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, German, Hebrew, Italian, Spanish, Chinese (Taiwan)

Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
  • Study Drug
  • Risankizumab
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    This study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms.

    Study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at Week 0, Week 4, and then every 12 weeks for 52 Weeks (With the last dose being administered at Week 40). An additional visit will occur at Week 8 for a physical exam and questionnaire collection. A final follow-up phone call will occur at Week 60.

    Study Locations

    Location
    Status
    Location
    Alliance Dermatology and MOHs /ID# 216001
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    Burke Pharmaceutical Research /ID# 225023
    Hot Springs, Arkansas, United States, 71913-6404
    Status
    Not applicable
    Location
    Arkansas Research Trials /ID# 225497
    North Little Rock, Arkansas, United States, 72117
    Status
    Not applicable
    Location
    Bakersfield Derma & Skin Cance /ID# 213480
    Bakersfield, California, United States, 93309
    Status
    Not applicable
    Location
    UC Davis Health /ID# 225367
    Sacramento, California, United States, 95816-3300
    Status
    Not applicable
    Location
    CCD Research, PLLC /ID# 216062
    Cromwell, Connecticut, United States, 06416-1745
    Status
    Not applicable
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