A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects

Summary

This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 60 weeks. This includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week extension period and a 8 week Follow up Period.

Timeline

Start

2018-11-26

Primary completion

2021-02-05

Completion

2021-02-05

Publications

• Chen Y, Lukic T, Chen AS, Adiri R, Tran H, Schaefer G, Ghosh P, Madhavan S, Soma K, Gamalo M. Automated Measurement of Depigmentation Extent with a New AI Tool Applied to the Example of Vitiligo. Dermatol Ther (Heidelb). 2026 Jun;16(6):3139-3149. doi: 10.1007/s13555-026-01736-8. Epub 2026 May 4.
• Yamaguchi Y, Peeva E, Duca ED, Facheris P, Bar J, Shore R, Cox LA, Sloan A, Thaci D, Ganesan A, Han G, Ezzedine K, Ye Z, Guttman-Yassky E. Ritlecitinib, a JAK3/TEC family kinase inhibitor, stabilizes active lesions and repigments stable lesions in vitiligo. Arch Dermatol Res. 2024 Jul 18;316(7):478. doi: 10.1007/s00403-024-03182-y.
• Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2.
• Guttman-Yassky E, Del Duca E, Da Rosa JC, Bar J, Ezzedine K, Ye Z, He W, Hyde C, Hassan-Zahraee M, Yamaguchi Y, Peeva E. Improvements in immune/melanocyte biomarkers with JAK3/TEC family kinase inhibitor ritlecitinib in vitiligo. J Allergy Clin Immunol. 2024 Jan;153(1):161-172.e8. doi: 10.1016/j.jaci.2023.09.021. Epub 2023 Sep 28.
• Ezzedine K, Peeva E, Yamaguchi Y, Cox LA, Banerjee A, Han G, Hamzavi I, Ganesan AK, Picardo M, Thaci D, Harris JE, Bae JM, Tsukamoto K, Sinclair R, Pandya AG, Sloan A, Yu D, Gandhi K, Vincent MS, King B. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial. J Am Acad Dermatol. 2023 Feb;88(2):395-403. doi: 10.1016/j.jaad.2022.11.005. Epub 2022 Nov 9.

Drugs

Indications