PF-06651600 for the Treatment of Alopecia Areata

Summary

This is a global Phase 2b/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 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Timeline

Start

2018-12-03

Primary completion

2020-12-31

Completion

2021-06-24

Outcome

Met primary endpoint

registry analysis (superiority test); Ritlecitinib (PF-06651600) 200 mg Then 50 mg vs Placebo; p <0.000001; Estimate of difference 29.11 (95% CI 21.17 to 37.91); Miettinen and Nurminen method NCT03732807 ↗

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.
• Mauer J, Whichello C, Hauber B, Krucien N, Law EH, Trapali M, Senna M, Zwillich SH, Wolk R, Tervonen T. A Patient Preference-Weighted Quantitative Benefit-Risk Analysis of Ritlecitinib for Alopecia Areata to Inform Medical Decision Making. Value Health. 2026 Feb;29(2):277-284. doi: 10.1016/j.jval.2025.09.007. Epub 2025 Sep 24.
• Mostaghimi A, Gibson A, Dwyer G, Oluboyede Y, Mazar I, Gorbatenko-Roth K, Law E. Exploring Factors That Influence the Measurement of Patient-Reported Impacts of Alopecia Areata. Dermatol Ther (Heidelb). 2025 Jun;15(6):1391-1403. doi: 10.1007/s13555-025-01400-7. Epub 2025 Apr 22.
• 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.
• Sinclair R, Mesinkovska N, Mitra D, Wajsbrot D, Law EH, Wolk R, King B. Patient-Reported Hair Loss and Its Impacts as Measured by the Alopecia Areata Patient Priority Outcomes Instrument in Patients Treated with Ritlecitinib: The ALLEGRO Phase 2b/3 Randomized Clinical Trial. Am J Clin Dermatol. 2025 Jan;26(1):109-119. doi: 10.1007/s40257-024-00899-4. Epub 2024 Oct 23.
• Mesinkovska N, King B, Zhang X, Guttman-Yassky E, Magnolo N, Sinclair R, Mizuashi M, Shapiro J, Peeva E, Banerjee A, Takiya L, Cox LA, Wajsbrot D, Kerkmann U, Law E, Wolk R, Schaefer G. Efficacy and safety of ritlecitinib, an oral JAK3/TEC family kinase inhibitor, in adolescent and adult patients with alopecia totalis and alopecia universalis. J Dermatol. 2024 Nov;51(11):1414-1424. doi: 10.1111/1346-8138.17442. Epub 2024 Sep 27.
• Fu J, Egeberg A, Holmes S, Vano-Galvan S, Steinhoff M, Edwards R, Bonfanti G, Nagra R, Wolk R, Tran H, Law E. Impact of Previous Alopecia Areata Treatment on Efficacy Responses up to Week 48 Following Ritlecitinib Treatment: A Post Hoc Analysis. Dermatol Ther (Heidelb). 2024 Oct;14(10):2759-2769. doi: 10.1007/s13555-024-01260-7. Epub 2024 Sep 10.
• 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.
• 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.
• Thaci D, Tziotzios C, Ito T, Ko J, Karadag AS, Fang H, Edwards RA, Bonfanti G, Wolk R, Tran H, Law E. Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study. Dermatol Ther (Heidelb). 2023 Nov;13(11):2621-2634. doi: 10.1007/s13555-023-00997-x. Epub 2023 Sep 14.
• King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. A plain language summary on ritlecitinib treatment for adults and adolescents with alopecia areata. Immunotherapy. 2023 Oct;15(14):1093-1103. doi: 10.2217/imt-2023-0069. Epub 2023 Jul 5.
• King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023 May 6;401(10387):1518-1529. doi: 10.1016/S0140-6736(23)00222-2. Epub 2023 Apr 14.

Drugs

Indications