Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in Adult Participants With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

Study Identifier
M20-326
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, Polish

Study Details

Medical Condition
  • Dermatology - Psoriasis (PsO)
  • Study Drug
  • Risankizumab
  • Apremilast
  • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. Adverse events and change in disease symptoms will be monitored.

    Risankizumab (Skyrizi) and apremilast are approved drugs for the treatment of moderate to severe PsO. Approximately 330 participants with moderate plaque psoriasis (PsO) will be enrolled across approximately 55 sites globally.

    The study has 2 periods : Period A from Baseline to Week 16, and Period B, from Week 16 to Week 52. In Period A, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. In Period B, participants who received apremilast in Period A will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. At weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab.

    There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Dermatology Center /ID# 233793
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Advanced Research Associates - Glendale /ID# 229266
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Alliance Dermatology and MOHs Center, PC /ID# 229224
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    UC Davis Health /ID# 229133
    Sacramento, California, United States, 95816-3300
    Status
    Not applicable
    Location
    Florida Academic Centers Research and Education /ID# 229235
    Coral Gables, Florida, United States, 33134
    Status
    Not applicable
    Location
    Olympian Clinical Research - Largo /ID# 233792
    Largo, Florida, United States, 33770
    Status
    Not applicable
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