CTP-543 Shows Promising Results in Advanced Alopecia Areata Trial: 35% of Patients Achieve Significant Hair Regrowth

Concert Pharmaceuticals’ oral investigational treatment CTP-543 has demonstrated encouraging efficacy in combating moderate to severe alopecia areata, an autoimmune condition characterized by patchy or complete hair loss on the scalp. The results from the Phase 3 THRIVE-AA1 clinical trial were unveiled during a late-breaking session at the 31st European Academy of Dermatology and Venereology (EADV) Congress, with the presentation led by Brett King, M.D., from Yale University School of Medicine’s Department of Dermatology.

Clinical Trial Outcomes: Beyond Primary Endpoints

The THRIVE-AA1 study evaluated two dosing regimens of CTP-543—8 mg and 12 mg administered twice daily—against placebo over a 24-week treatment period. While both doses met the study’s primary endpoint of achieving an absolute Severity of Alopecia Tool (SALT) score of 20 or less (indicating 20 percent or less hair loss), the results revealed more robust outcomes than initially anticipated.

Most notably, 35 percent of patients receiving the higher 12 mg twice-daily dose of CTP-543 achieved a SALT score of 10 or less at Week 24—corresponding to at least 90 percent scalp hair coverage. The 8 mg twice-daily cohort showed 21 percent of participants reaching this more stringent threshold. These results contrast sharply with the placebo group, where 0 percent of patients achieved this level of hair regrowth.

Expanded Benefits: Eyebrow and Eyelash Regeneration

Beyond scalp hair recovery, newly disclosed data from the THRIVE-AA1 trial highlight CTP-543’s potential to stimulate regrowth in other body hair regions commonly affected by alopecia areata. Patients treated with both dose levels of CTP-543 demonstrated significant improvements in eyebrow and eyelash regeneration, suggesting the compound’s broader therapeutic capacity in addressing the multifaceted manifestations of this autoimmune disorder.

Safety Profile and Clinical Implications

Throughout the trial duration, CTP-543 maintained a favorable tolerability profile, with treatment-related adverse events consistent with expectations for this drug class. These findings position CTP-543 as a potential therapeutic advance for dermatology, offering alopecia areata patients a systemic oral treatment option rather than conventional topical approaches.