Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)

Phase 3 Completed 517 enrolled Concert Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.

Timeline

Start: 2021-06-10
Primary completion: 2022-06-08
Completion: 2022-06-29

Outcome

Met primary endpoint

registry Placebo vs CTP-543 8 mg BID; p <0.0001; Risk Difference (RD) 0.31 (95% CI 0.25 to 0.37) NCT04797650 ↗

registry Placebo vs CTP-543 12 mg BID; p <0.0001; Risk Difference (RD) 0.36 (95% CI 0.27 to 0.45) NCT04797650 ↗

Publications

Tsianakas A, Passeron T, Magnolo N, Blume-Peytavi U, Kelly V, Day I, Serrao R, Guttman-Yassky E, Sticherling M, Csernus AE, Moreno-Arrones OM, Hamilton C, Cassella J. Efficacy and safety of deuruxolitinib, an oral selective Janus kinase 1/2 inhibitor, in adults with alopecia areata: Results from the THRIVE-AA2 Phase 3, randomized, double-blind, controlled trial. J Am Acad Dermatol. 2026 Apr;94(4):1134-1143. doi: 10.1016/j.jaad.2025.11.070. Epub 2025 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CTP-543	Unknown	8 mg	Oral
Subject	CTP-543	Unknown	12 mg	Oral