A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo
Public ClinicalTrials.gov record NCT06118411. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06118411
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 614 participants
Conditions and interventions
Conditions
Interventions
- Upadacitinib Drug
- Placebo Drug
- NB-UVB (narrow-band ultraviolet B) Phototherapy Other
Drug · Other
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 18, 2023
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
- Last update posted
- Jun 8, 2026
2023 – 2028
United States locations
- U.S. sites
- 46
- U.S. states
- 15
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Associates - Glendale /ID# 259915 | Glendale | Arizona | 85308 | — |
| Alliance Dermatology and Mohs Center /ID# 259926 | Phoenix | Arizona | 85032 | — |
| Private Practice - Dr. Tooraj Raoof /ID# 260055 | Encino | California | 91436 | — |
| University of California Irvine /ID# 260080 | Irvine | California | 92697-1385 | — |
| Vitiligo & Pigmentation Institute of Southern California /ID# 259970 | Los Angeles | California | 90036-5679 | — |
| Dermatology Research Associates /ID# 260056 | Los Angeles | California | 90045 | — |
| Duplicate_Stanford University /ID# 260081 | Redwood City | California | 94063 | — |
| Integrative Skin Science and Research /ID# 260060 | Sacramento | California | 95815 | — |
| University of California Davis Health /ID# 260062 | Sacramento | California | 95817 | — |
| Clinical Trials Research Institute /ID# 259910 | Thousand Oaks | California | 91320-2130 | — |
| Skin Care Research Boca Raton /ID# 260094 | Boca Raton | Florida | 33486-2269 | — |
| Apex Clinical Trials /ID# 260096 | Brandon | Florida | 33511 | — |
| Florida Academic Dermatology Center /ID# 259919 | Coral Gables | Florida | 33134-5755 | — |
| Direct Helpers Research Center /ID# 259932 | Hialeah | Florida | 33012 | — |
| Skin Care Research - Hollywood /ID# 260101 | Hollywood | Florida | 33021-6748 | — |
| Encore Medical Research /ID# 259963 | Hollywood | Florida | 33021 | — |
| GSI Clinical Research, LLC /ID# 259918 | Margate | Florida | 33063 | — |
| Life Clinical Trials - N State Rd - Margate /ID# 260097 | Margate | Florida | 33063 | — |
| Savin Medical Group, LLC /ID# 259968 | Miami Lakes | Florida | 33014 | — |
| Advanced Clinical Research Institute - Tampa /ID# 260058 | Tampa | Florida | 33607 | — |
| Encore Medical Research - Weston /ID# 260542 | Weston | Florida | 33331 | — |
| Cleaver Medical Group Dermatology /ID# 259925 | Dawsonville | Georgia | 30534 | — |
| DeNova Research /ID# 260611 | Chicago | Illinois | 60610 | — |
| Indiana University Health University Hospital /ID# 259974 | Indianapolis | Indiana | 46202 | — |
| Dawes Fretzin /ID# 260068 | Indianapolis | Indiana | 46256 | — |
| Tufts Medical Center. /ID# 260088 | Boston | Massachusetts | 02111-1552 | — |
| UMass Memorial Medical Center - Lake Avenue North /ID# 259921 | Worcester | Massachusetts | 01655 | — |
| Oakland Hills Dermatology /ID# 260602 | Auburn Hills | Michigan | 48326 | — |
| Great Lakes Research Group - Bay City /ID# 260600 | Bay City | Michigan | 48706 | — |
| Hamzavi Dermatology - Canton /ID# 260545 | Canton | Michigan | 48187 | — |
| Clarkston Dermatology /ID# 260069 | Clarkston | Michigan | 48346 | — |
| Henry Ford Medical Center - New Center One /ID# 260059 | Detroit | Michigan | 48202-3046 | — |
| Minnesota Clinical Study Center /ID# 260154 | New Brighton | Minnesota | 55112 | — |
| Vivida Dermatology- Flamingo /ID# 260609 | Las Vegas | Nevada | 89119-5190 | — |
| Schweiger Dermatology, P.C. /ID# 260152 | New York | New York | 07044-2946 | — |
| Icahn School of Medicine at Mount Sinai /ID# 259909 | New York | New York | 10029 | — |
| DermResearchCenter of New York, Inc. /ID# 259906 | Stony Brook | New York | 11790 | — |
| ClinOhio Research Services /ID# 260300 | Columbus | Ohio | 43213-4440 | — |
| Oregon Medical Research Center /ID# 259911 | Portland | Oregon | 97201 | — |
| Oregon Dermatology and Research Center /ID# 259917 | Portland | Oregon | 97210 | — |
| Medical University of South Carolina /ID# 259916 | Charleston | South Carolina | 29425 | — |
| Bellaire Dermatology Associates /ID# 260044 | Bellaire | Texas | 77401 | — |
| Dermatology Treatment and Research Center /ID# 260078 | Dallas | Texas | 75230 | — |
| Innovative Dermatology - Plano /ID# 260628 | Plano | Texas | 75024 | — |
| Dermatology Clinical Research Center of San Antonio /ID# 260047 | San Antonio | Texas | 78229 | — |
| Progressive Clinical Research /ID# 260070 | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 102 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06118411, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06118411 live on ClinicalTrials.gov.