AbbVie’s upadacitinib achieves endpoint in Phase 3 alopecia areata trial

AbbVie (ABBV) announced “positive” topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib in adult and adolescent patients with severe alopecia areata with a mean baseline SALT score of 84.0. In Study 1, both doses of upadacitinib achieved the primary endpoint, with 45.2% and 55.0% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reaching 80% or more scalp hair coverage at week 24, vs. 1.5% of patients receiving placebo. These results are consistent with the topline results from the first parallel replicate study of the Phase 3 UP-AA clinical program. 35.2% and 45.8% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage vs. 0.7% of patients receiving placebo at week 24. The safety profile of both doses of upadacitinib was generally consistent with that observed in approved indications. Use of upadacitinib in AA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.