Key insights
- Merck's investigational monoclonal antibody, tulisokibart, met its primary endpoint in a Phase 2b trial for moderate to severe hidradenitis suppurativa (HS). High-dose patients showed a 72% response rate for a 50% reduction in abscesses and inflammatory nodules. These positive results, the first for an anti-TL1A antibody in dermatology, will guide Phase 3 development. Tulisokibart is also being studied in other inflammatory conditions.
Merck (MRK) announced results from a Phase 2b trial of tulisokibart, an investigational monoclonal antibody, in patients with moderate to severe hidradenitis suppurativa (HS), a chronic inflammatory skin disease. The data were presented at the European Academy of Dermatology and Venereology 2026 Congress.
The trial, designated MK-7240-012, met its primary endpoint of HiSCR50 — a 50% reduction in abscesses and inflammatory nodules — at week 16. In the high-dose group (480 mg every two weeks), 72% of patients achieved the endpoint, compared with 64% in the medium-dose group (480 mg every four weeks) and 35% in the placebo group. A low-dose group (240 mg every four weeks) showed a 52% response rate in an exploratory analysis.
For key secondary endpoints, HiSCR75 was achieved by 41% of high-dose and 40% of medium-dose patients, versus 15% in the placebo group. Mean reductions in the Dermatology Life Quality Index from baseline were -5.62 for the high-dose group and -3.50 for the medium-dose group, compared with -2.46 for placebo.
Adverse events occurred in 42.9%, 47.6%, and 52.4% of high-, medium-, and low-dose patients, respectively, versus 40.9% in the placebo group. Serious adverse events were reported in 2.4% of both high- and medium-dose patients, 4.8% of low-dose patients, and 2.3% of placebo patients. No serious or opportunistic infections were observed.
Merck stated the results represent the first positive Phase 2 data for an anti-TL1A monoclonal antibody in dermatology. The company said these findings will inform Phase 3 development of tulisokibart in HS. Tulisokibart is currently being evaluated across six disease indications, with ongoing Phase 3 studies in ulcerative colitis and Crohn’s disease, and Phase 2 studies in rheumatoid arthritis, psoriatic arthritis, and radiographic axial spondyloarthritis.
The lead investigator, Alexa B. Kimball, MD, MPH, of Harvard Medical School, is a paid consultant to Merck.
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