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NCT06072183 · ClinicalTrials.gov registry record · Phase 3
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
A Phase 3 study of Stable Nonsegmental Vitiligo and Active Nonsegmental Vitiligo, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 1,571
- Enrollment target
- 20
- Study locations
NCT06072183 is a Phase 3 study of Stable Nonsegmental Vitiligo and Active Nonsegmental Vitiligo that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 1,571 participants. The trial reports 20 study locations across 4 states.
The verdict
NCT06072183, a Phase 3 study of Stable Nonsegmental Vitiligo and Active Nonsegmental Vitiligo, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,571 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands. Ritlecitinib has been tested in earlier clinical studies and has a favorable safety profile. At present there are no approved medications taken by mouth to treat nonsegmental vitiligo. This study is seeking participants who: * Are 18 years of age or older. * are confirmed to have nonsegmental vitiligo for at least 3 months. * Are willing to stop all other treatments that they may be taking for vitiligo. In this study participants will be chosen by chance, like drawing names out of a hat to receive 1 of 3 treatments: •Part I where two different amounts of ritlecitinib (50 mg and 100 mg) are taken once daily. It will be compared to placebo. Placebo is a dummy capsule. It doesn't have any medicine used in the study. Participants receiving placebo who have not responded to treatment after 52 weeks will be given 100 milligrams or 50 milligrams of ritlecitinib for the remaining 52 weeks of the study. • In Part II, participants will only receive 100 milligrams of ritlecitinib. About 1000 participants will take part in Part I and around 450 in Part II globally. The study will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help see if ritlecitinib is safe and effective. People in Part I will be in this study for about 26 months and people in Part II will be in this study for about 14 months. During the study, participants in part I will need to visit the study site at least 17 times. In part II, participants will visit at least 11 times. Participants will undergo various tests and procedures such as: * vitiligo rating, * physical examinations, * hearing tests, * blood
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ritlecitinib
Study Locations (20)
California
- First OC Dermatology Research Inc - Fountain Valley
- Seaside Audiology Vertigo & Ear Specialists - Huntington Beach
- Wallace Medical Group, Inc - Los Angeles
- Kaiser Permanente - Oakland
- Cura Clinical Research - Oxnard - Oxnard
- Mission Dermatology Center - Rancho Santa Margarita
- Peninsula Research Associates - Rolling Hills Estates
- Integrative Skin Science and Research - Sacramento
- University of California San Diego - La Jolla - San Diego
- Wolverine Clinical Trials - Santa Ana
Florida
- Encore Medical Research of Boynton Beach - Boynton Beach
- FXM Clinical Research - Fort Lauderdale - Fort Lauderdale
- Direct Helpers Research Center - Hialeah
- Harmony Medical Research Institute - Hialeah
- Clever Medical Research - Miami
- JD Medical Group - Miami
- Miami Dermatology and Laser Research - Miami
- SouthCoast Research Center - Miami
Arizona
- Center for Dermatology and Plastic Surgery/CCT Research - Scottsdale
Arkansas
- Dermatology Trial Associates - Bryant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,571 participants |
| Start Date | 2023-11-08 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06072183
The ClinicalTrials.gov registry entry for NCT06072183 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,571 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stable Nonsegmental Vitiligo appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06072183 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06072183 about?
NCT06072183 is a clinical study titled "A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2". The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sid...
What is the current status of trial NCT06072183?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,571 participants. The study started on 2023-11-08. Estimated completion is 2027-07-30.
What conditions does trial NCT06072183 study?
This clinical trial studies the following conditions: Stable Nonsegmental Vitiligo, Active Nonsegmental Vitiligo.
What interventions are being tested in trial NCT06072183?
The interventions under investigation include: Placebo (DRUG), Ritlecitinib (DRUG).
Who is sponsoring clinical trial NCT06072183?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06072183 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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