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# Rinvoq Meets Endpoints in Alopecia Trial
- URL: https://www.fdaweb.com/rinvoq-meets-endpoints-in-alopecia-trial/
- Published: 2025-08-21T12:00:00.000Z
- Updated: 2026-09-14T15:19:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159736

AbbVie is reporting that its JAK inhibitor Rinvoq (upadacitinib) met primary and secondary endpoints in a pivotal Phase 3 study testing the drug in patients with severe alopecia areata (AA). The company says that its Study 1 of the UP-AA program saw 45.2% of patients receiving a 15 mg dose and 55% receiving a 30 mg dose achieve at least 80% scalp hair coverage at 24 weeks, compared with just 1.5% on placebo. AbbVie said the results were consistent with outcomes from its first replicate Phase 3 trial announced earlier this year.

AbbVie says the impressive regrowth was also seen at higher thresholds — 35.2% and 45.8% of patients on the 15 mg and 30 mg doses respectively, reached 90% or more scalp coverage, versus 0.7% on placebo. The trial also showed improvements in eyebrow and eyelash regrowth, and some patients achieved complete hair regrowth by Week 24.

The safety profile was consistent with RINVOQ’s approved uses in other inflammatory conditions, according to the company. Serious adverse events occurred in fewer than 2% of treated patients, with discontinuation rates also low. The most common side effects were upper respiratory tract infections, acne, elevated creatine phosphokinase, and nasopharyngitis, it says, adding that no major adverse cardiovascular events, venous thromboembolic events, or deaths were reported.

Rinvoq is already approved in the U.S. for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and other immune-mediated conditions, and AbbVie says it plans to share the alopecia areata Phase 3 data with FDA.