AbbVie announced today that its JAK inhibitor Rinvoq (upadacitinib) has reached the primary endpoint in a critical study of the Phase 3 UP-AA clinical project. Analysis shows that among severe alopecia areata (AA) patients treated with doses of 15 mg and 30 mg, 44.6% and 54.3% achieved scalp hair coverage of over 80% at 24 weeks of treatment, respectively. The results of another parallel study of the Phase 3 clinical project are expected to be announced in the third quarter of 2025.
The UP-AA Phase 3 clinical project announced this time includes two identical key studies, designed as randomized double-blind, placebo-controlled trials, aimed at evaluating the efficacy and safety of once daily upadacitinib in adult and adolescent patients with severe alopecia areata.
The results of Study 2 are being released this time. Analysis showed that both 15 mg and 30 mg of upadacitinib achieved the primary endpoint: 44.6% and 54.3% of patients achieved SALT ≤ 20 (i.e. scalp hair coverage of 80% or more) at week 24, respectively, while only 3.4% of patients receiving placebo achieved this goal (p<0.001).
In addition, 36.0% and 47.1% of patients, respectively, achieved SALT ≤ 10 (above 90% scalp hair coverage) at week 24 after receiving treatment with 15 mg and 30 mg upadacitinib, compared to only 1.4% in the placebo group (p<0.001). Other key secondary endpoints achieved included the improvement rate of eyebrows and eyelashes, as well as the proportion of subjects in both dose groups who achieved complete scalp hair coverage (SALT=0) at week 24.
Upadacitinib was discovered and developed by scientists at AbbVie, and is a JAK inhibitor used to treat various immune-mediated inflammatory diseases. Based on enzymatic and cellular analysis, upadacitinib has a greater inhibitory effect on JAK1 than JAK2, JAK3, and TYK2. Upadacitinib is currently undergoing evaluation in phase 3 clinical trials for diseases such as alopecia areata, purulent sweat gland inflammation, systemic lupus erythematosus, and vitiligo.
<Reprinted from WuXi AppTec>
