RAHWAY, New Jersey, September 30, 2026

Merck announced positive results from its Phase 2b MK-7240-012 clinical trial evaluating tulisokibart, an investigational humanized monoclonal antibody, in patients with moderate to severe hidradenitis suppurativa (HS). The randomized, double-blind, placebo-controlled study met its primary endpoint of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 for both the high-dose and medium-dose treatment groups. The findings represent the first positive Phase 2 data reported for an anti-TL1A monoclonal antibody in dermatology, according to Merck. Results were presented in a Late-Breaking News session at the European Academy of Dermatology and Venereology (EADV) 2026 Congress.

Tulisokibart Delivers Positive HiSCR50 Results

The MK-7240-012 Phase 2b study evaluated tulisokibart in adults with moderate to severe HS during a 16-week double-blind treatment period. Participants received high-dose tulisokibart at 480 mg every two weeks, medium-dose treatment at 480 mg every four weeks, low-dose treatment at 240 mg every four weeks, or placebo. At Week 16, 72% of patients receiving the high-dose regimen achieved HiSCR50, compared with 35% receiving placebo. In the medium-dose group, 64% achieved HiSCR50, also exceeding the placebo response. An exploratory analysis showed a 52% response rate with the low-dose regimen. HiSCR50 was defined as at least a 50% reduction in total abscesses and inflammatory nodules, with no increase in abscesses or draining tunnels.

Key Secondary Endpoints Show Improvement

Merck also reported numerical improvements across the study’s key secondary endpoints, including HiSCR75 and the Dermatology Life Quality Index (DLQI) at Week 16. HiSCR75 was achieved by 41% of patients in the high-dose group and 40% in the medium-dose group, compared with 15% in the placebo group. The low-dose group recorded a 29% response rate. Quality-of-life measurements also improved, with mean DLQI reductions of 5.62 points for high-dose tulisokibart and 3.50 points for medium-dose treatment, compared with a 2.46-point reduction for placebo. Merck described the secondary endpoint improvements as numerical, while the low-dose group did not show an improvement over placebo for DLQI.

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Anti-TL1A Approach Advances in Dermatology

Tulisokibart is an investigational anti-TL1A monoclonal antibody designed to block signaling from tumor necrosis factor-like cytokine 1A (TL1A). Merck is investigating whether targeting TL1A can influence inflammatory and immuno-fibrotic pathways involved in immune-mediated diseases. Hidradenitis suppurativa is a chronic inflammatory skin disease characterized by painful nodules and abscesses that can progress to draining tunnels, fibrosis and scarring. Merck estimates that HS affects approximately 1 in 100 people worldwide, while significant gaps remain in long-term disease control. The safety findings from MK-7240-012 were generally comparable between tulisokibart and placebo groups. Adverse events occurred in 42.9% of patients receiving high-dose tulisokibart, 47.6% receiving medium-dose treatment, and 52.4% receiving low-dose treatment, compared with 40.9% for placebo. Serious adverse events occurred at relatively similar rates across the groups, and no serious or opportunistic infections were observed during the study. Based on the Phase 2b findings, Merck said it plans to advance tulisokibart into Phase 3 development for hidradenitis suppurativa. The therapy is also being studied in other immune-mediated inflammatory diseases, including ulcerative colitis, Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis.

Source: Merck press release