Long-Term PF-06651600 for the Treatment of Alopecia Areata

Summary

This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug. A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

Timeline

Start

2019-07-18

Primary completion

2024-06-25

Completion

2026-02-26

Publications

• Senna M, Soung J, Figueras I, King B, Kinoshita-Ise M, Hanna S, Wu W, Wajsbrot D, Woodworth D, Wolk R, Chaudhry A, Lejeune A, Tran H. Long-Term Efficacy and Safety of Ritlecitinib in Adults and Adolescents with Alopecia Areata: 3-Year Results from the ALLEGRO Phase 2b/3 and ALLEGRO-LT Phase 3 Clinical Studies. Am J Clin Dermatol. 2026 Mar 31. doi: 10.1007/s40257-026-01029-y. Online ahead of print.
• Ueki R, Mizuashi M, Harada K, Zhang X, Wu W, Chung WH, Kwon O, Luo X, Basey V, Wolk R, Shi N, Fujita K, Shen Y, Hirose T. Efficacy and Safety of Ritlecitinib in the Asian Subpopulation of the ALLEGRO-2b/3 and ALLEGRO-LT Clinical Studies for Alopecia Areata. J Dermatol. 2026 Apr;53(4):578-586. doi: 10.1111/1346-8138.70154. Epub 2026 Feb 6.
• Ishowo-Adejumo R, Zareba A, Wajsbrot D, Wolk R. Responses to Tetanus and Meningococcal Vaccines in Patients with Alopecia Areata Treated with Ritlecitinib. Dermatol Ther (Heidelb). 2026 Feb;16(2):1411-1417. doi: 10.1007/s13555-025-01648-z. Epub 2026 Jan 24.
• King B, Mirmirani P, Lo Sicco K, Ramot Y, Sinclair R, Asfour L, Ezzedine K, Paul C, Ohyama M, Edwards RA, Bonfanti G, Kerkmann U, Wajsbrot D, Ishowo-Adejumo R, Zwillich SH, Lejeune A. Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1163-1173. doi: 10.1111/jdv.20547. Epub 2025 Feb 17.
• Tziotzios C, Sinclair R, Lesiak A, Mehlis S, Kinoshita-Ise M, Tsianakas A, Luo X, Law EH, Ishowo-Adejumo R, Wolk R, Sadrarhami M, Lejeune A. Long-term safety and efficacy of ritlecitinib in adults and adolescents with alopecia areata and at least 25% scalp hair loss: Results from the ALLEGRO-LT phase 3, open-label study. J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1152-1162. doi: 10.1111/jdv.20526. Epub 2025 Jan 23.
• Piliang M, Soung J, King B, Shapiro J, Rudnicka L, Farrant P, Magnolo N, Piraccini BM, Luo X, Wolk R, Woodworth D, Schaefer G, Lejeune A. Efficacy and safety of the oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family kinase inhibitor ritlecitinib over 24 months: integrated analysis of the ALLEGRO phase IIb/III and long-term phase III clinical studies in alopecia areata. Br J Dermatol. 2025 Jan 24;192(2):215-227. doi: 10.1093/bjd/ljae365.
• Piliang M, Lynde C, King B, Mirmirani P, Sinclair R, Senna M, Forman S, Bordone L, De La Cueva Dobao P, Wolk R, Zwillich SH, Tran H, Wajsbrot D, Ahmed HM, Takiya L. Sustained hair regrowth with continued ritlecitinib treatment through week 48 in patients with alopecia areata with or without early target responses: Post hoc analysis of the ALLEGRO phase 2b/3 trial. J Am Acad Dermatol. 2025 Feb;92(2):276-284. doi: 10.1016/j.jaad.2024.09.064. Epub 2024 Oct 17.
• King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska NA, Paul C, Gong Y, Anway SD, Tran H, Wolk R, Zwillich SH, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. Am J Clin Dermatol. 2024 Mar;25(2):299-314. doi: 10.1007/s40257-024-00846-3. Epub 2024 Jan 23.

Drugs

Indications