35.2% and 45.8% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage (SALT ≤ 10), compared to 0.7% of patients receiving placebo at week 24 (p<0.001).1 Additional key secondary endpoints that were met included percentage of subjects with improvements in eyebrows and eyelashes, as well as the percentage of subjects with complete scalp hair coverage (SALT=0) with both doses of upadacitinib at week 24.1 "People living with AA often face considerable uncer ...

Core Insights - AbbVie announced positive topline results from the Phase 3 UP-AA clinical program for upadacitinib (RINVOQ®) in treating severe alopecia areata, showing significant efficacy in hair regrowth [1][3][4] Efficacy Results - In Study 2, 44.6% of patients on 15 mg and 54.3% on 30 mg of upadacitinib achieved 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 3.4% in the placebo group (p<0.001) [1][3] - Additionally, 36.0% and 47.1% of patients reached 90% or more scalp hair coverage (SALT ≤ 10) with the respective doses, against 1.4% in the placebo group (p<0.001) [1][3] Safety Profile - The safety profile of upadacitinib was consistent with previous studies, with serious adverse events occurring in 1.4% and 2.8% of patients in the 15 mg and 30 mg groups, respectively, and none in the placebo group [1][3] - Common treatment-emergent adverse events included acne, nasopharyngitis, and upper respiratory tract infections, with serious infections reported infrequently [1][3] Study Design - The UP-AA clinical program consists of two pivotal studies (Study 1 and Study 2) with a total of 1,399 participants aged 12 to 64 across 248 sites globally [4][3] - Participants were randomized to receive either upadacitinib or placebo for 24 weeks, followed by an additional 28 weeks for those originally on upadacitinib [4] Future Outlook - Results from the parallel Study 1 are expected in the third quarter of 2025, which will further inform the efficacy and safety of upadacitinib in alopecia areata [3][4]

Core Insights - Q32 Bio Inc. has initiated dosing for the first patients in both Part A open-label extension and Part B of the SIGNAL-AA Phase 2a clinical trial for bempikibart, targeting alopecia areata [1][2] - The company reports encouraging clinical activity from Part A, with significant improvements in SALT scores and sustained responses observed in patients up to 55 weeks post-treatment [2][3] - Part B of the trial will involve approximately 20 patients over 36 weeks, with topline data expected in the first half of 2026 [3] Company Overview - Q32 Bio is a clinical stage biotechnology company focused on innovative therapies for alopecia areata and other autoimmune diseases, with an estimated 700,000 individuals affected in the U.S. [4] - The company is advancing bempikibart, a fully human anti-IL-7Rα antibody, which aims to re-regulate adaptive immune function [4] Clinical Trial Details - Part A of the SIGNAL-AA trial was a randomized, double-blind, placebo-controlled study that demonstrated significant clinical activity in patients with severe alopecia areata [2][3] - Part B will evaluate the efficacy of bempikibart based on mean percentage change in SALT scores and the proportion of subjects achieving specific SALT improvements [3]