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A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo
NCT06118411 · View on ClinicalTrials.gov ↗
Study 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 (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 effec
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Upadacitinib
- OTHER NB-UVB (narrow-band ultraviolet B) Phototherapy
Study Locations (20)
Florida
- Skin Care Research Boca Raton /ID# 260094 — Boca Raton
- Apex Clinical Trials /ID# 260096 — Brandon
- Florida Academic Dermatology Center /ID# 259919 — Coral Gables
- Direct Helpers Research Center /ID# 259932 — Hialeah
- Skin Care Research - Hollywood /ID# 260101 — Hollywood
- Encore Medical Research /ID# 259963 — Hollywood
- GSI Clinical Research, LLC /ID# 259918 — Margate
- Life Clinical Trials /ID# 260097 — Margate
- Savin Medical Group, LLC /ID# 259968 — Miami Lakes
- Advanced Clinical Research Institute /ID# 260058 — Tampa
California
- Private Practice - Dr. Tooraj Raoof /ID# 260055 — Encino
- University of California Irvine /ID# 260080 — Irvine
- Vitiligo & Pigmentation Institute of Southern California /ID# 259970 — Los Angeles
- Dermatology Research Associates /ID# 260056 — Los Angeles
- Duplicate_Stanford University /ID# 260081 — Redwood City
- Integrative Skin Science and Research /ID# 260060 — Sacramento
- University of California Davis Health /ID# 260062 — Sacramento
- Clinical Trials Research Institute /ID# 259910 — Thousand Oaks
Arizona
- Advanced Research Associates - Glendale /ID# 259915 — Glendale
- Alliance Dermatology and Mohs Center /ID# 259926 — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2023-12-19 |
| Est. Completion | 2028-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06118411
The ClinicalTrials.gov registry entry for NCT06118411 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 614 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Vitiligo appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06118411 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06118411 about?
NCT06118411 is a clinical study titled "A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo". 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...
What is the current status of trial NCT06118411?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 614 participants. The study started on 2023-12-19. Estimated completion is 2028-02.
What conditions does trial NCT06118411 study?
This clinical trial studies the following conditions: Vitiligo. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06118411?
The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG), NB-UVB (narrow-band ultraviolet B) Phototherapy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06118411?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06118411 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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