Results mark the first positive Phase 2 data for an anti-TL1A monoclonal antibody in dermatology
Tulisokibart was designed to help address immuno-fibrosis, a key driver of disease progression in HS
Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from MK-7240-012, a Phase 2b multicenter, randomized, double-blind, placebo-controlled trial evaluating tulisokibart, an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderate to severe hidradenitis suppurativa (HS). These data will be presented in a Late-Breaking News session at the European Academy of Dermatology and Venereology (EADV) 2026 Congress (Abstract ID: LB-26).
The study met its primary endpoint of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at week 16 for patients treated with both high-dose (480 mg Q2W) and medium-dose (480 mg Q4W) tulisokibart regimens, demonstrating superiority over placebo. Specifically, 72% of patients in the high-dose group (n=42) and 64% in the medium-dose group (n=42) achieved HiSCR50—representing a 37% and 29% improvement over the placebo group (35%, n=44), respectively. In an exploratory analysis, the low-dose group (n=21, 240 mg Q4W) achieved a 52% response rate, a 17% improvement over placebo. There was comparable safety between tulisokibart and placebo groups in this trial.
For the non-ranked key secondary endpoints at week 16, both the high- and medium- dose groups showed greater numerical improvement over placebo. HiSCR75 was achieved by 41% of high-dose, 40% of medium-dose, and 29% of low-dose patients, compared to 15% in the placebo group—representing numeric improvements over placebo of 27%, 24%, and 13%, respectively. Additionally, patient quality of life numerically improved, with mean Dermatology Life Quality Index (DLQI) reductions from baseline of -5.62 (a 3.16-point improvement over placebo) for the high-dose cohort and -3.50 (a 1.02-point improvement over placebo) for the medium-dose cohort, compared to a baseline reduction of -2.46 in the placebo group. The low-dose cohort showed no improvement over placebo.