Merck reports positive Phase 2b data for tulisokibart in HS

Merck announced on September 30, 2026, positive results from its MK-7240-012 Phase 2b study evaluating tulisokibart in patients with moderate to severe hidradenitis suppurativa (HS). The investigational anti-TL1A monoclonal antibody met its primary endpoint of HiSCR50 at week 16 across high-dose and medium-dose groups, demonstrating superiority over placebo.

In the trial, 72% of patients in the high-dose group (480 mg every two weeks, n=42) and 64% in the medium-dose group (480 mg every four weeks, n=42) reached HiSCR50. These outcomes represented improvements of 37% and 29% over the placebo group, which recorded a 35% response rate (n=44). An exploratory low-dose cohort (240 mg every four weeks, n=21) achieved a 52% response rate, a 17% improvement over placebo.

On key secondary measures at week 16, HiSCR75 was reached by 41% of high-dose, 40% of medium-dose, and 29% of low-dose patients, compared with 15% on placebo. Reductions in the Dermatology Life Quality Index reached -5.62 points in the high-dose arm and -3.50 points in the medium-dose arm, compared with -2.46 points for placebo. Adverse event rates stood at 42.9% for high dose, 47.6% for medium dose, 52.4% for low dose, and 40.9% for placebo, with serious adverse events ranging between 2.3% and 4.8% across groups and no serious or opportunistic infections.

Dr. Aileen Pangan, vice president and therapeutic area head of immunology clinical research at Merck Research Laboratories, confirmed that the drugmaker plans to advance tulisokibart into Phase 3 trials for hidradenitis suppurativa.