A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Condition(s) studied
Investigational drug(s) / intervention(s)
Ritlecitinib: 100mg Capsule
Ritlecitinib: 50mg Capsule
Placebo: Matching capsule
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 tests,
* x-ray,
* ECG,
* photographs of areas with vitiligo. Participants will be asked to complete questionnaires about their vitiligo.
Eligibility
Primary outcome measure(s)
- US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and Total body Vitiligo Area Scoring Index 50 (T-VASI50) at Week 52 — 52 Weeks
Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline) and T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline) - Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 — 52 Weeks
Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline). - Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to discontinuation. — Baseline through 108 weeks
To evaluate the safety and tolerability of ritlecitinib in adult participants with non segmental vitiligo - Incidence of Clinically significant laboratory abnormalities. — Baseline through 108 weeks
Trial sites (229)
| Facility | City | Region | Status |
|---|---|---|---|
| Center for Dermatology and Plastic Surgery/CCT Research | Scottsdale | Arizona | |
| Dermatology Trial Associates | Bryant | Arkansas | |
| First OC Dermatology Research Inc | Fountain Valley | California | |
| Seaside Audiology Vertigo & Ear Specialists | Huntington Beach | California | |
| Wallace Medical Group, Inc | Los Angeles | California | |
| Kaiser Permanente | Oakland | California | |
| Cura Clinical Research - Oxnard | Oxnard | California | |
| Mission Dermatology Center | Rancho Santa Margarita | California | |
| Peninsula Research Associates | Rolling Hills Estates | California | |
| Integrative Skin Science and Research | Sacramento | California | |
| University of California San Diego - La Jolla | San Diego | California | |
| Wolverine Clinical Trials | Santa Ana | California | |
| Encore Medical Research of Boynton Beach | Boynton Beach | Florida | |
| FXM Clinical Research - Fort Lauderdale | Fort Lauderdale | Florida | |
| Direct Helpers Research Center | Hialeah | Florida | |
| Clever Medical Research | Miami | Florida | |
| Miami Dermatology and Laser Institute | Miami | Florida | |
| SouthCoast Research Center | Miami | Florida | |
| University of Miami Dermatology Clinical Trials Unit | Miami | Florida | |
| University of Miami | Miami | Florida | |
| Bio-Medical Research LLC | Miami | Florida | |
| New Horizon Research Center | Miami | Florida | |
| Skin Research of South Florida | Miami | Florida | |
| Well Pharma Medical Research, Corp. | Miami | Florida | |
| FXM Clinical Research - Miami | Miami | Florida | |
| Health and Life Research Institute | Miami | Florida | |
| University of Miami, Kendall Office | Miami | Florida | |
| Floridian Research Institute Llc | Miami | Florida | |
| Sanitas Research | Miami | Florida | |
| Wellness Clinical Research | Miami Lakes | Florida | |
| FXM Clinical Research - Miramar | Miramar | Florida | |
| GCP Research, Global Clinical professionals | St. Petersburg | Florida | |
| Advanced Clinical Research Institute | Tampa | Florida | |
| USF Health | Tampa | Florida | |
| Sidney P. Smith, MD, PC dba Georgia Skin & Cancer Clinic | Savannah | Georgia | |
| Endeavor Health Audiology -CHICAGO | Chicago | Illinois | |
| Endeavor Health Audiology -LAKE BLUFF | Lake Bluff | Illinois | |
| Endeavor Health Audiology-NORTHBROOK | Northbrook | Illinois | |
| Endeavor Health Audiology-SKOKIE | Skokie | Illinois | |
| Endeavor Health-Dermatology Clinical Trials Unit | Skokie | Illinois |
+ 189 more sites — see the full list on the official registry below.
More Pfizer trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06072183 on ClinicalTrials.gov ↗ ← All trials in Italy