Status:
ACTIVE_NOT_RECRUITING
A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo
Lead Sponsor:
AbbVie
Conditions:
Vitiligo
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Documented clinical diagnosis of non-segmented vitiligo (NSV).
- At Screening and Baseline Visits, participants must satisfy at least 1 of the following criteria:
- \>= 0.5 F-VASI and 5 \<= T-VASI \< 50 AND have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or
- \>= 0.5 F-VASI and 5 \<= T-VASI \< 50 AND have a sign of actively progressing vitiligo; or
- \>= 0.5 F-VASI and 10 \<= T-VASI \< 50.
Exclusion
- Segmental or localized vitiligo.
- History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo.
- \>33% leukotrichia in areas of vitiligo on the face or \> 33% leukotrichia in areas of vitiligo on the body (including the face).
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2028
Estimated Enrollment :
614 Patients enrolled
Trial Details
Trial ID
NCT06118411
Start Date
December 19 2023
End Date
February 1 2028
Last Update
November 10 2025
Active Locations (148)
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1
Advanced Research Associates - Glendale /ID# 259915
Glendale, Arizona, United States, 85308
2
Alliance Dermatology and Mohs Center /ID# 259926
Phoenix, Arizona, United States, 85032
3
Private Practice - Dr. Tooraj Raoof /ID# 260055
Encino, California, United States, 91436
4
University of California Irvine /ID# 260080
Irvine, California, United States, 92697-1385