In the extension, 4 of 13 (31%) patients receiving 24 µg/kg and 4 of 14 (29%) receiving 18 µg/kg newly achieved SALT 20 or lower, compared with 0 of 4 receiving placebo.1 Across the study population, SALT 20 or lower rates rose from 15.6% to 27.6% with 24 µg/kg and from 14.8% to 25.8% with 18 µg/kg between weeks 36 and 52, while placebo remained at 6.7%.
At week 52, SALT 30 or lower was achieved by 35.0%, 30.2%, and 8.4% of patients receiving 24 µg/kg, 18 µg/kg, and placebo, respectively, and SALT50 by 38.8%, 37.7%, and 13.6%.1 Week 52 results for patients outside the extension were carried forward from week 36, with multiple imputation for missing extension data. Rosmarin noted responses had not yet plateaued by week 52.
Overall, 94% of extension patients completed the 16-week period, and no increased risk of conjunctivitis, oral herpes, or malignancy was observed across a combined database of more than 1,000 rezpegaldesleukin-treated patients.1 Rosmarin said the phase 3 program is set to begin at the end of 2026. These congress data have not been peer reviewed.
Disclosures for Rosmarin include AbbVie, Abcuro, Almirall, AltruBio, Amgen, Arena, Astria, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, and others.
References
Rosmarin D, Ungar B, Mesinkovska N, et al. Rezpegaldesleukin, a novel regulatory T cell-inducing biologic, demonstrates efficacy and safety in severe-to-very-severe alopecia areata: 52-week results from the phase 2b REZOLVE-AA study. Abstract 1872. Presented at: EADV Congress 2026; September 30–October 3, 2026; Vienna, Austria.A phase 2b study to evaluate rezpegaldesleukin (rezpeg) in the treatment of severe to very severe alopecia areata in adult patients (REZOLVE AA). ClinicalTrials.gov identifier: NCT06340360. Accessed October 13, 2026. https://clinicaltrials.gov/study/NCT06340360