MSD 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.
“Hidradenitis suppurativa is a painful, chronic disease that can have a profound physical and emotional impact on patients,” said Alexa B. Kimball,* MD, MPH, 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.”
“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 Dr. Aileen Pangan, vice president and therapeutic area head, immunology clinical research, MSD Research Laboratories. “We look forward to advancing tulisokibart to Phase 3 for patients living with HS.”
Adverse events (AEs) occurred in 42.9%, 47.6%, and 52.4% of participants receiving high-, medium-, and low-dose tulisokibart, respectively, compared with 40.9% in the placebo group. Serious AEs were infrequent and occurred at similar rates across treatment groups: 2.4% in both the high- and medium-dose groups, 4.8% in the low-dose group, and 2.3% with placebo. No serious or opportunistic infections were observed in the study.
These data presented at EADV will inform Phase 3 development for tulisokibart in HS. Tulisokibart has the broadest development program in the novel anti-TL1A class and is currently being evaluated in six disease indications across multiple immune-mediated inflammatory diseases. Phase 3 studies include ATLAS-UC in ulcerative colitis (UC) and ARES-CD in Crohn’s disease (CD). Phase 2 studies are evaluating tulisokibart in rheumatoid arthritis (RA), psoriatic arthritis (PsA), radiographic axial spondyloarthritis (r-axSpA), and HS.
