Health
AbbVie Announces Positive Topline Results from Second Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata
AbbVie (NYSE: ABBV) today announced positive topline results from the second 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 84.0 (approximately 16% scalp hair coverage).1
About this update from Abbvie Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"In the second replicate study (Study 1) of the pivotal Phase 3 UP-AA clinical program, upadacitinib (RINVOQ®) achieved the primary endpoint, demonstrating that 45.2% and 55.0% 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":386,"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 met 1 ","length":226,"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":"These results are consistent with the topline results from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program","length":141,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":907,"olType":false},{"type":"text","content":"NORTH CHICAGO, Ill., Aug. 21, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the second 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 84.0 (approximately 16% scalp hair coverage).1","length":431,"tagName":"p"},{"type":"text","content":"In Study 1, both doses of upadacitinib achieved the primary endpoint, with 45.2% and 55.0% 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 1.5% of patients receiving placebo (p<0.001).1 These results are consistent with the topline results previously announced from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program.","length":456,"tagName":"p"},{"type":"text","content":""These positive results strengthen the growing body of evidence supporting the potential of upadacitinib ...