Merck: tulisokibart met HiSCR50 primary endpoint in Phase 2b HS trial
- Primary endpoint met at week 16: high-dose (480 mg Q2W) HiSCR50 72% (n=42) and medium-dose (480 mg Q4W) 64% (n=42) versus placebo 35% (n=44).
- Exploratory low-dose (240 mg Q4W, n=21) achieved HiSCR50 52%, a 17% improvement over placebo.
- HiSCR75 rates were 41% (high), 40% (medium), 29% (low) versus 15% placebo; DLQI mean reductions were −5.62 (high) and −3.50 (medium) versus −2.46 placebo.
- Adverse events were similar across groups (42.9% high, 47.6% medium, 52.4% low, 40.9% placebo); serious AEs were infrequent and comparable; no serious or opportunistic infections observed. Data will inform Phase 3.
Trial and context
MK-7240-012 is a Phase 2b, randomized, double-blind, placebo-controlled study of tulisokibart, an anti-TL1A monoclonal antibody, in participants with moderate to severe hidradenitis suppurativa (HS). The design implemented a Bayesian approach to augment concurrent controls with historical placebo for the primary endpoint. Results were presented at the EADV 2026 Congress.
Primary efficacy
The study met its primary endpoint of HiSCR50 at week 16 for both high- and medium-dose regimens. HiSCR50 rates were 72% for high-dose (480 mg Q2W; n=42) and 64% for medium-dose (480 mg Q4W; n=42), versus 35% for placebo (n=44), representing improvements of 37% and 29% over placebo. An exploratory low-dose cohort (240 mg Q4W; n=21) achieved 52% HiSCR50 (17% improvement over placebo). HiSCR50 was defined as ≥50% reduction in abscesses and inflammatory nodules with no increase in abscess or draining tunnel counts.
Secondary endpoints and quality of life
Non-ranked key secondary endpoints showed numeric benefit: HiSCR75 at week 16 was 41% (high), 40% (medium), 29% (low) versus 15% placebo. Mean DLQI reductions from baseline were −5.62 (high; a 3.16‑point improvement over placebo) and −3.50 (medium; a 1.02‑point improvement over placebo), compared with −2.46 for placebo; the low-dose cohort showed no DLQI improvement versus placebo.
Safety and next steps
Overall adverse event rates were comparable to placebo (42.9% high, 47.6% medium, 52.4% low, 40.9% placebo). Serious adverse events were infrequent (2.4% high and medium, 4.8% low, 2.3% placebo) and no serious or opportunistic infections were observed. Merck says these are the first positive Phase 2 data for an anti‑TL1A antibody in dermatology and that the results will inform Phase 3 development; tulisokibart is being evaluated across multiple immune‑mediated indications.
Source: Merck