Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo

Study Identifier
M19-051
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
Plain Language Summary
Available Language(s): English, French, Japanese

Study Details

Medical Condition
  • Vitiligo
  • Study Drug
  • Upadacitinib
  • Placebo
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 65 Years

    Protocol Summary

    Vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. This study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo. Adverse effects and change in disease activity will be assessed.

    Upadacitinib is being evaluated for the treatment of non-segmental vitiligo. The study will enroll approximately 160 participants aged 18-65 with non-segmental vitiligo in 5 treatment arms across 35 sites worldwide.

    Participants will either receive study drug vs placebo oral tablets once daily (QD) for 24 weeks (Period A). In Period B (up to 52 weeks), participants who received placebo during the first 24 weeks will switch to study drug. Participants who received study drug during the first 24 weeks, will continue to receive study drug.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    University of California Irvine /ID# 229390
    Irvine, California, United States, 92697-1385
    Status
    Not applicable
    Location
    Stanford University /ID# 228000
    Redwood City, California, United States, 94063
    Status
    Not applicable
    Location
    Clearlyderm Dermatology /ID# 227993
    Boca Raton, Florida, United States, 33428
    Status
    Not applicable
    Location
    New Horizon Research Center /ID# 229403
    Miami, Florida, United States, 33165-3372
    Status
    Not applicable
    Location
    Park Avenue Dermatology, PA /ID# 229400
    Orange Park, Florida, United States, 32073
    Status
    Not applicable
    Location
    ForCare Clinical Research /ID# 228010
    Tampa, Florida, United States, 33613-1244
    Status
    Not applicable
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