AbbVie’s RINVOQ Hits Key Goal in Second Late-Stage Alopecia Trial

AbbVie reported that upadacitinib, marketed as RINVOQ, met the primary endpoint in the second pivotal Phase 3 UP-AA trial for severe alopecia areata. After 24 weeks of treatment, 45.2% of participants receiving the 15 mg once-daily dose and 55.0% of those on the 30 mg dose achieved at least 80% scalp-hair coverage, compared with 1.5% in the placebo arm (p<0.001). Key secondary goals were also reached: 35.2% and 45.8% of patients on the 15 mg and 30 mg doses respectively attained 90% or greater coverage, while complete scalp regrowth was observed in a subset of participants. Safety findings were broadly in line with RINVOQ’s approved indications, with serious adverse events reported in under 2% of treated patients and no new safety signals identified. The replicate study mirrors results from the first Phase 3 trial, reinforcing the efficacy profile of the JAK inhibitor for an indication that currently has limited treatment options. AbbVie said it intends to include the data in regulatory filings, moving the drug closer to potential approval for alopecia areata in both adult and adolescent patients.