AbbVie's Rinvoq Meets Primary Goal in Late-Stage Trial for Alopecia Areata Treatment.

AbbVie's experimental drug candidate Rinvoq (upadacitinib) has met the main goal in the second study of two pivotal late-stage trials for treating severe alopecia areata. The trials are testing 15 mg and 30 mg daily doses of Rinvoq. AbbVie aims to treat this autoimmune condition, which causes hair loss.

AbbVie (NYSE: ABBV) has reported positive topline results from the second Phase 3 trial (Study 1) of its UP-AA clinical program, evaluating upadacitinib (RINVOQ®) for the treatment of severe alopecia areata. The study, which enrolled 1,399 participants with severe AA across 248 sites worldwide, met its primary endpoint with 45.2% of patients on 15 mg and 55.0% on 30 mg achieving ≥80% scalp hair coverage at week 24, compared to 1.5% for placebo [1].

Key secondary endpoints were also achieved, with 35.2% and 45.8% of patients on 15 mg and 30 mg doses, respectively, reaching ≥90% scalp hair coverage, compared to 0.7% for placebo. Additionally, the drug showed improvements in eyebrow and eyelash growth, which significantly impact patients' quality of life and psychological wellbeing [2].

The safety profile of upadacitinib in this study was generally consistent with its established profile in other indications. Treatment-emergent serious adverse events occurred in 1.9% (15 mg) and 1.8% (30 mg) of patients, and discontinuation rates due to treatment-emergent adverse events were 1.1% (15 mg) and 1.5% (30 mg) [2].

These consistent results from both pivotal Phase 3 trials position AbbVie strongly for regulatory submission. If approved, upadacitinib would represent a significant advancement in alopecia areata treatment, expanding the drug's indication portfolio beyond rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ulcerative colitis, thus broadening its commercial potential and strengthening AbbVie's immunology franchise [1].

References:
[1] https://www.stocktitan.net/news/ABBV/abb-vie-announces-positive-topline-results-from-second-phase-3-up-aa-uq50osexzfpx.html
[2] https://www.morningstar.com/news/pr-newswire/20250821cg55893/abbvie-announces-positive-topline-results-from-second-phase-3-up-aa-trial-evaluating-upadacitinib-rinvoq-for-alopecia-areata