Health
AbbVie Announces Positive Topline Results from Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata
AbbVie (NYSE: ABBV) today announced positive topline results from the first of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 83.8 (approximately 16% scalp hair coverage).1
About this update from Abbvie Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"In Study 2 of the pivotal Phase 3 UP-AA clinical program, upadacitinib (RINVOQ®) achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe alopecia areata treated with upadacitinib 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 201","length":357,"tagName":"p"}]},{"val":[{"type":"text","content":"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, were also met1 ","length":225,"tagName":"p"}]},{"val":[{"type":"text","content":"The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study1","length":154,"tagName":"p"}]},{"val":[{"type":"text","content":"Results from the parallel replicate study (Study 1) of the Phase 3 UP-AA clinical program are also expected in the third quarter of 2025","length":136,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":872,"olType":false},{"type":"text","content":"NORTH CHICAGO, Ill., July 30, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the first of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 83.8 (approximately 16% scalp hair coverage).1","length":430,"tagName":"p"},{"type":"text","content":"In Study 2, both doses of upadacitinib achieved the primary endpoint, with 44.6% and 54.3% 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 3.4% of patients receiving placebo (p<0.001).1","length":292,"tagName":"p"},{"type":"text","content":""Often misunderstood as a cosmetic issue, AA is a systemic immune-mediated disease that can cause total hair loss, involving the scalp, eyebrows and eyelashes. People living with AA may face difficulties in managing their disease, which can significantly affect their quality of life," said Kori Wall...