AbbVie's Upadacitinib Shines in Alopecia Areata Trial with Positive Results

AbbVie announced positive topline results from the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib in adult and adolescent patients with severe alopecia areata. Both doses of upadacitinib achieved the primary endpoint, with 45.2% and 55.0% of patients reaching 80% or more scalp hair coverage at week 24, compared to 1.5% of patients receiving placebo. The safety profile was generally consistent with approved indications. Use of upadacitinib in AA is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

AbbVie (NYSE: ABBV) has announced positive topline results from the second replicate study (Study 1) of its Phase 3 UP-AA clinical program, evaluating the safety and efficacy of upadacitinib (RINVOQ®) in adult and adolescent patients with severe alopecia areata (AA). The drug achieved its 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 as defined by the severity of alopecia tool (SALT) score ≤ 201 [1].

The study, conducted as part of the Phase 3 randomized, placebo-controlled, double-blind UP-AA M23-716 trial, randomized 1,399 participants with severe AA across 248 sites worldwide. Both doses of upadacitinib also met key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤ 10) and complete scalp hair coverage (SALT=0) at week 24 [1].

The safety profile of upadacitinib in the 24-week, placebo-controlled period (Period A) was generally consistent with that observed in approved indications. Treatment-emergent serious adverse events occurred in 1.9% and 1.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and 0.7% in the placebo group [1].

AbbVie's vice president of global head of immunology clinical development, Kori Wallace, M.D., Ph.D., expressed optimism about the results, stating, "These positive results strengthen the growing body of evidence supporting the potential of upadacitinib to improve the lives of people with AA" [1].

Upadacitinib is a JAK inhibitor being studied in several immune-mediated inflammatory diseases. It is currently approved for use in various conditions such as rheumatoid arthritis, psoriatic arthritis, and others. However, its use in AA is not yet approved, and its safety and efficacy in this indication have not been evaluated by regulatory authorities [1].

The trial's results are encouraging and consistent with the topline results from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program. The study's findings underscore the potential of upadacitinib to provide meaningful hair regrowth, offering hope for those enduring the psychosocial burden associated with AA [1].

References:
[1] https://news.abbvie.com/2025-08-21-AbbVie-Announces-Positive-Topline-Results-from-Second-Phase-3-UP-AA-Trial-Evaluating-Upadacitinib-RINVOQ-R-for-Alopecia-Areata