Safety Assessments in the Multinational Phase 3 THRIVE-AA1 Trial with CTP-543 (Deuruxolitinib) in Adult Patients with Moderate to Severe Alopecia Areata

The THRIVE-AA1 trial assessed the safety of CTP-543, a JAK1/JAK2 inhibitor, in 706 adult patients with moderate to severe alopecia areata. Participants were randomized to receive either a placebo, 8 mg BID, or 12 mg BID of CTP-543 for 24 weeks. Common adverse events included headache, nasopharyngitis, and upper respiratory tract infections. Serious adverse events were rare, with only one possibly related to CTP-543. The incidence and severity of adverse events were similar across the treatment groups, and no significant trends were observed in vital signs or ECG results. The study concluded that both doses of CTP-543 were generally well tolerated, with an encouraging safety profile for treating alopecia areata.