This study has 245 international locations - 08 Nov `23A Study of Ritlecitinib in Adolescent and Adult Participants With Non-Segmental Vitiligo (Tranquillo 2)

The Ritlecitinib for Vitiligo (Tranquillo 2 Trial), sponsored by Pfizer, is a Phase 3 clinical study evaluating the efficacy and safety of ritlecitinib, a Janus Kinase (JAK) inhibitor, in adults with non-segmental vitiligo (NSV). The trial aims to determine if ritlecitinib can effectively restore skin pigmentation by modulating the immune response responsible for melanocyte destruction.

Key Details:

- Study Type: Interventional (Clinical Trial)
- Phase: Phase 3
- Estimated Enrollment: 1450 participants
- Age Range: 12 years and older
- Duration: Approximately 104 weeks, including treatment and follow-up periods

This randomized, placebo-controlled trial will assess the effectiveness of ritlecitinib, an oral medication, compared to a placebo in patients with NSV. Participants will be randomly assigned to receive either ritlecitinib or a placebo for the first 24 weeks. After this initial period, all participants will receive ritlecitinib for an additional 24 weeks.

Inclusion Criteria:

• Adults aged 12 years or older
• Clinical diagnosis of non-segmental vitiligo for at least 3 months
• Willingness to discontinue all other vitiligo treatments from screening through the final safety follow-up visit

Exclusion Criteria

• Use of any investigational drug within 30 days prior to the study
• History of significant medical conditions that could interfere with study participation
• Pregnancy or breastfeeding

For a complete list of inclusion and exclusion criteria, interested individuals should contact the study team or visit the official ClinicalTrials.gov page (NCT06072183). Only the research staff can determine if a person fully qualifies for the study.

Additional Details

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.

This study has 245 locations in USA, as well as in Australia, Belgium, Bulgaria, Canada, China, Germany, Hungary, Italy, Japan, Mexico, Poland, Slovakia, Spain, Taiwan, Turkey and United Kingdom.

The VRF will continue to monitor the progress of this trial and provide updates as they become available. We encourage eligible individuals to consider participating in this important research effort to advance vitiligo treatment.