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Official title: A phase 3 open-label, multi-center extension study investigating the safety, efficacy, and tolerability of ritlecitinib in adult and adolescent participants with nonsegmental vitiligo
This ongoing clinical trial is investigating the use of ritlecitinib in patients with non-segmental vitiligo (NSV). This Phase 3 study, sponsored by Pfizer, aims to evaluate the efficacy and safety of ritlecitinib in treating vitiligo in both adolescents and adults.
Key Details:
- Study Type: Interventional (Clinical Trial)
- Phase: Phase 3
- Estimated Enrollment: 540 participants
- Age Range: 12 years and older
- Duration: 48 weeks
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.
Primary Outcome Measures:
1. Percentage of participants achieving ≥75% improvement from baseline in facial Vitiligo Area Scoring Index (F-VASI75) at Week 24
2. Percentage of participants achieving a Vitiligo Noticeability Scale (VNS) score of 4 or 5 at Week 24
This study is currently recruiting participants at multiple locations across the United States and internationally.
Inclusion and Exclusion Criteria:
- Age: 12 years and older
- Diagnosis: Non-segmental vitiligo (NSV)
- Sex: Both males and females are eligible
For a complete list of inclusion and exclusion criteria, interested individuals should contact the study team or visit the official ClinicalTrials.gov page (NCT06163326). Only the research staff can determine if a person fully qualifies for the study.
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.
Start date: 2024-01-19
Completion date: 2027-01-30
Contact: Pfizer
Tel.: NA1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Link: https://www.pfizerclinicaltrials.com/find-a-trial/nct06163326-vitiligo-trial
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