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NCT06118411 · ClinicalTrials.gov registry record · Phase 3
A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo
A Phase 3 study of Vitiligo, sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 614
- Enrollment target
- 20
- Study locations
NCT06118411: Active Phase 3 study of Vitiligo, sponsored by AbbVie.
NCT06118411 is a Phase 3 study of Vitiligo that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 614 participants, below the 1,083-participant average among 15 other Vitiligo trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06118411, a Phase 3 study of Vitiligo, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 614 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. It is based on a composite estimate of the overall area of vitiligo patches, measured by the number of hand units (palm plus 5 digits = 1% body surface area \[BSA\]) multiplied by the degree of depigmentation within each affected area (0%, 10%, 25%, 50%, 75%, 90%, or 100%). The T-VASI is calculated using a formula that includes contributions from all body regions, with
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 |
What the registry record for NCT06118411 still lists
NCT06118411 is an interventional study that assigns participants to a tested intervention. The registered 614 participants enrollment target is mid-sized for trials with a published cap, below the 1,083-participant average among 15 other Vitiligo trials with a reported enrollment target (43% lower).
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.
NCT06118411 names 20 study sites across 3 states, led by Florida, California, Arizona.
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.
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).
Who is sponsoring clinical trial NCT06118411?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06118411's enrollment target sits among peer trials
614 2nd of 15 the highest of 15 other Vitiligo trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vitiligo trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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