Upadacitinib Shows Significant Hair Regrowth in Second Phase 3 Trial for Severe Alopecia Areata

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AbbVie announced positive topline results from the second pivotal phase 3 trial of its UP-AA clinical program, evaluating upadacitinib for severe alopecia areata (AA) in adults and adolescents. Both the 15 mg and 30 mg once-daily doses achieved the primary endpoint, demonstrating significant hair regrowth at 24 weeks compared with placebo.

In Study 1, 45.2% of participants receiving 15 mg and 55.0% of those receiving 30 mg achieved at least 80% scalp hair coverage, defined as a Severity of Alopecia Tool (SALT) score ≤20, compared with 1.5% of placebo-treated participants (P < .001). These findings are consistent with results from the first replicate phase 3 study (Study 2).

Key secondary endpoints were also met. By week 24, 35.2% and 45.8% of participants in the 15 mg and 30 mg groups, respectively, achieved at least 90% scalp coverage (SALT ≤10), versus 0.7% in the placebo group (P < .001). Improvements in eyebrow and eyelash regrowth, as well as complete scalp coverage (SALT = 0), were observed with both doses.

The study enrolled patients with severe AA (mean baseline SALT score of 84.0, equivalent to 16% scalp coverage) across 248 sites worldwide. Together, the two replicate phase 3 trials randomized 1,399 participants aged 12 to 64 years.

The safety profile of upadacitinib in AA was generally consistent with that in approved indications. Treatment-emergent serious adverse events occurred in 1.9% and 1.8% of patients in the 15 mg and 30 mg groups, respectively, and 0.7% in the placebo group. Discontinuation due to adverse events occurred in 1.1% and 1.5% of the upadacitinib groups, with none in placebo. The most common adverse events were upper respiratory tract infection, acne, increased creatine phosphokinase, and nasopharyngitis. Serious infections were infrequent. No adjudicated major adverse cardiovascular events, venous thromboembolic events, or deaths were reported.

Use of upadacitinib for alopecia areata has not been approved by regulatory authorities, and safety and efficacy in this indication remain under review. AbbVie stated that it intends to submit the phase 3 trial data to regulatory agencies.

Reference: AbbVie announces positive topline results from second phase 3 UP-AA trial evaluating upadacitinib (RINVOQ®) for alopecia areata. News release. Abbvie. August 21, 2025. Accessed August 22, 2025. 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