Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1)

Phase 3 Completed 706 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: 2020-11-23
Primary completion: 2022-04-19
Completion: 2022-04-19

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs CTP-543 8 mg BID; p <0.0001; Risk Difference (RD) 0.28 (95% CI 0.23 to 0.33); NCT04518995 ↗

registry analysis (superiority test); Placebo vs CTP-543 12 mg BID; p <0.0001; Risk Difference (RD) 0.39 (95% CI 0.32 to 0.46); NCT04518995 ↗

paper Significantly higher proportions of patients taking deuruxolitinib met the primary end point (8 mg 29.6%; 12 mg 41.5% versus placebo 0.8%). PMID 39053611 ↗

Publications

King B, Senna MM, Mesinkovska NA, Lynde C, Zirwas M, Maari C, Prajapati VH, Sapra S, Brzewski P, Osman L, Hanna S, Wiseman MC, Hamilton C, Cassella J. Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1). J Am Acad Dermatol. 2024 Nov;91(5):880-888. doi: 10.1016/j.jaad.2024.06.097. Epub 2024 Jul 23.

Drugs

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