American pharmaceutical company Eli Lilly and Company (NYSE: LLY) and US-based biopharmaceutical firm Incyte (NASDAQ: INCY) on Friday reported positive one-year results from the Phase 3 BRAVE-AA-PEDS trial evaluating baricitinib in adolescents with severe alopecia areata.

The once-daily oral JAK inhibitor, marketed as Olumiant, achieved successful scalp hair regrowth in 71% of adolescents with severe disease after one year of treatment with the 4 mg dose, with continuous improvement observed throughout the 52-week period.

At one year, 54.1% of patients treated with baricitinib 4 mg and 31% with 2 mg achieved at least 80% scalp hair coverage. Near-complete scalp regrowth was achieved by 41.2% on 4 mg and 26.2% on 2 mg. Eyebrow and eyelash regrowth also improved substantially across both treatment groups.

Safety findings were consistent with previous trials, showing no new safety signals after one year, however, adverse effects included acne and susceptibility to infections.

Eli Lilly plans to submit the BRAVE-AA-PEDS data to global regulators to support a potential label update for Olumiant, extending its indication to adolescents. The company also plans to begin enrolling children aged six to under twelve in the next phase of the study in the U.S.

Baricitinib, discovered by Incyte and licensed to Lilly, is already approved for adults with severe alopecia areata in the US, Europe, and Japan.