MSD, known as Merck in the US and Canada, has announced the first presentation of results from MK-7240-012, a phase 2b multicentre, randomised, double-blind, placebo-controlled trial evaluating tulisokibart, an investigational humanised monoclonal antibody targeting tumour necrosis factor-like cytokine 1A (TL1A), in patients with moderate to severe hidradenitis suppurativa (HS).
The results mark the first positive phase 2 data for an anti-TL1A monoclonal antibody in dermatology and the data will be presented in a Late-Breaking News session at the European Academy of Dermatology and Venereology (EADV) 2026 Congress.
“Hidradenitis suppurativa is a painful, chronic disease that can have a profound physical and emotional impact on patients,” said Alexa B. Kimball, lead investigator of the study, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, and Professor of Dermatology at Harvard Medical School. “Despite available advanced therapies, many still do not achieve long-term disease control. Results from the MK-7240-012 trial are promising and suggest the potential for meaningful improvement in the management of this difficult-to-treat condition.”
The study met its primary endpoint of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at week 16 for patients treated with both high-dose and medium-dose tulisokibart regimens, demonstrating superiority over placebo. Specifically, 72% of patients in the high-dose group and 64% in the medium-dose group achieved HiSCR50, representing a 37% and 29% improvement over the placebo group, respectively. In an exploratory analysis, the low-dose group achieved a 52% response rate, a 17% improvement over placebo. There was comparable safety between tulisokibart and placebo groups in this trial.
“We are excited to expand the clinical data for tulisokibart beyond inflammatory bowel disease with these positive phase 2b results – the first for the anti-TL1A class in dermatology,” said Aileen Pangan, vice president and therapeutic area head, immunology clinical research, Merck Research Laboratories. “We look forward to advancing tulisokibart to phase 3 for patients living with HS.”