Tulisokibart Meets Phase 2b Primary Endpoint in Hidradenitis Suppurativa
Key Takeaways
- Tulisokibart met the Phase 2b MK-7240-012 trial’s primary week 16 HiSCR50 endpoint at both the high- and medium-dose regimens in patients with moderate-to-severe hidradenitis suppurativa (HS).
- HiSCR50 response rates were 72% with high-dose tulisokibart and 64% with the medium dose, compared with 35% with placebo. HiSCR75 and quality-of-life outcomes were non-ranked secondary endpoints and showed numerical differences versus placebo.
- Adverse event rates were generally similar across groups, with no serious or opportunistic infections reported. Merck said the results will inform Phase 3 development in HS.
Tulisokibart, an investigational monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), met the primary endpoint in a Phase 2b trial evaluating the therapy in patients with moderate-to-severe hidradenitis suppurativa (HS), according to results presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026.
The multicenter, randomized, double-blind, placebo-controlled MK-7240-012 trial evaluated high-dose tulisokibart (480 mg every 2 weeks), medium-dose tulisokibart (480 mg every 4 weeks), low-dose tulisokibart (240 mg every 4 weeks), and placebo over 16 weeks. The primary endpoint was Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), defined as at least a 50% reduction in total abscesses and inflammatory nodules without an increase in abscesses or draining tunnels.
Tulisokibart Improves HiSCR50 Response at Week 16
At week 16, 72% of patients receiving high-dose tulisokibart (n = 42) and 64% receiving the medium dose (n = 42) achieved HiSCR50 compared with 35% receiving placebo (n = 44), meeting the primary endpoint for both regimens. In an exploratory analysis, 52% of patients receiving the low-dose regimen (n = 21) achieved HiSCR50.
For the non-ranked secondary endpoint of HiSCR75, response rates were 41%, 40%, and 29% with high-, medium-, and low-dose tulisokibart, respectively, versus 15% with placebo. Mean Dermatology Life Quality Index reductions from baseline were 5.62 points with the high dose, 3.50 points with the medium dose, and 2.46 points with placebo; the low-dose cohort showed no numerical improvement over placebo.
Adverse events occurred in 42.9%, 47.6%, and 52.4% of patients in the high-, medium-, and low-dose groups, respectively, compared with 40.9% receiving placebo. Serious adverse events were infrequent, and no serious or opportunistic infections were reported.
Merck said the findings will inform Phase 3 development of tulisokibart for HS.