AbbVie's Rinvoq achieves key milestones in second Alopecia Areata Phase 3 trial.

AbbVie's autoimmune drug Rinvoq met its primary and key secondary endpoints in a second late-stage Phase 3 study for the treatment of alopecia areata, a disease causing sudden hair loss. The study showed 80% or more scalp hair coverage at week 24, and improvements in eyebrows and eyelashes. This follows similar results from a parallel Phase 3 study, with AbbVie expecting Rinvoq revenue to reach $11 billion in 2027.

AbbVie (NYSE: ABBV) announced positive topline results from the second of two pivotal Phase 3 studies of the UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®) in adult and adolescent patients with severe alopecia areata (AA). The study, conducted as a single protocol with two replicate pivotal studies (Study 1 and Study 2), demonstrated that 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 (SALT score ≤ 20) at week 24, compared to 1.5% of patients receiving placebo (p0.001) [1].

The study 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. The safety profile of both doses 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 expects Rinvoq revenue to reach $11 billion in 2027, driven by the growing body of evidence supporting its potential to improve the lives of people with AA. The company is encouraged by the improvements in both scalp and non-scalp hair regrowth observed with both doses of upadacitinib and looks forward to submitting these data to regulatory bodies [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