A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Vitiligo

In brief

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 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), an optional exploratory NB-UVB phototherapy study (Study 3), and a re-randomized dose-escalation study (Study 4). 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. In Period B, all participants will receive upadacitinib. Approximately 540 adult and adolescent participants with NSV will be enrolled between each main study at around 180 sites worldwide with an option for adult participants who completed Period A of either study and did not achieve T-VASI90 at week 48 while on study drug, to enter Study 3. Participants who failed to achieve T-VASI75 response at week 118 of Study 1 or 2 or at week 70 of Study 3 will be considered for entry into Study 4. 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 Narrow-Band Ultraviolet B (NB-UBV) phototherapy for at least 24 weeks followed by upadacitinib alone. In Study 4, participants will be re-randomized to receive oral tablets of upadacitinib 15 mg or 30 mg once a day for 56 weeks. 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.

Key facts

Study ID

NCT06118411

Run by

AbbVie

People needed

614

Starts

2023-12-19

Expected to finish

2028-03-01

Last updated by the study team

2026-06-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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
• Skin Care Research Boca Raton /ID# 260094 — Boca Raton, Florida, United States
• Apex Clinical Trials /ID# 260096 — Brandon, Florida, United States
• Florida Academic Dermatology Center /ID# 259919 — Coral Gables, Florida, United States
• Direct Helpers Research Center /ID# 259932 — Hialeah, Florida, United States
• Skin Care Research - Hollywood /ID# 260101 — Hollywood, Florida, United States
• Encore Medical Research /ID# 259963 — Hollywood, Florida, United States
• GSI Clinical Research, LLC /ID# 259918 — Margate, Florida, United States
• Life Clinical Trials - N State Rd - Margate /ID# 260097 — Margate, Florida, United States
• Savin Medical Group, LLC /ID# 259968 — Miami Lakes, Florida, United States
• Advanced Clinical Research Institute - Tampa /ID# 260058 — Tampa, Florida, United States
• Encore Medical Research - Weston /ID# 260542 — Weston, Florida, United States
• Cleaver Medical Group Dermatology /ID# 259925 — Dawsonville, Georgia, United States
• DeNova Research /ID# 260611 — Chicago, Illinois, United States
• Indiana University Health University Hospital /ID# 259974 — Indianapolis, Indiana, United States
• Dawes Fretzin /ID# 260068 — Indianapolis, Indiana, United States
• Advanced Research Associates - Glendale /ID# 259915 — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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