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A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy
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 (NSV). Adverse effects and change in disease activity will be assessed. Upadacitinib is an approved drug for various immune-mediated inflammatory diseases and is currently being investigated for the treatment of NSV. There will be 2 replicate studies running at the same time (Study 1 and Study 2 with periods A and B) and an optional exploratory Narrow-Band Ultraviolet B (NB-UVB) phototherapy study (Study 3). In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will receive placebo and 2 in 3 chance participants will receive upadacitinib. In Period B, all participants will receive upadacitinib. Approximately 270 adult and adolescent participants with NSV will be enrolled in each main study ((Study 1 and Study 2, 540 subjects total) at approximately 90 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI 90 at week 48 while on study drug, to enter Study 3. In Studies 1 and 2: Period A, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. In Period B, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. Participants will be followed up for 30 days. Study 3 participants will receive upadacitinib monotherapy or upadacitinib with NB-UBV phototherapy for at least 24 weeks followed by upadacitinib alone. 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.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
Advanced Research Associates - Glendale /ID# 259915
Glendale, Arizona, United States
Alliance Dermatology and Mohs Center /ID# 259926
Phoenix, Arizona, United States
Private Practice - Dr. Tooraj Raoof /ID# 260055
Encino, California, United States
University of California Irvine /ID# 260080
Irvine, California, United States
Vitiligo & Pigmentation Institute of Southern California /ID# 259970
Los Angeles, California, United States
Dermatology Research Associates /ID# 260056
Los Angeles, California, United States
Duplicate_Stanford University /ID# 260081
Redwood City, California, United States
Integrative Skin Science and Research /ID# 260060
Sacramento, California, United States
University of California Davis Health /ID# 260062
Sacramento, California, United States
Clinical Trials Research Institute /ID# 259910
Thousand Oaks, California, United States
Start Date
December 19, 2023
Primary Completion Date
September 23, 2025
Completion Date
February 1, 2028
Last Updated
November 10, 2025
614
ACTUAL participants
Upadacitinib
DRUG
Placebo
DRUG
NB-UVB (narrow-band ultraviolet B) Phototherapy
OTHER
Lead Sponsor
AbbVie
NCT07431177
NCT07352293
NCT07437560
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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