Tulisokibart met its HiSCR50 primary endpoint at 16 weeks in the phase 2b MK-7240-012 trial assessing moderate to severe hidradenitis suppurativa.
The investigational humanized monoclonal antibody tulisokibart, targeting tumor necrosis factor-like cytokine 1A (TL1A), met its primary endpoint of Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at the 16-week mark at both the high and medium doses in the phase 2b MK-7240-012 study of patients with moderate to severe
This was according to results from Merck presented in a late-breaking news session held at the
MK-7240-012 (NCT06956235) was designed as a multi-center, randomized, double-blind, placebo-controlled phase 2b analysis.¹˒² Participants received high-dose (480 mg every 2 weeks), medium-dose (480 mg every 4 weeks), or low-dose (240 mg every 4 weeks) tulisokibart or placebo over a 16-week double-blind period.¹
A HiSCR50 required a 50% reduction at minimum in combined abscess and inflammatory nodule count with a lack of increase in abscesses or draining tunnels. The trial implemented a Bayesian design, supplementing concurrent placebo information with historical placebo controls for the primary endpoint.¹ The results were presented as Abstract LB-26. Key secondary end points were HiSCR75 and mean change in Dermatology Life Quality Index (DLQI) at 16 weeks.
HiSCR50 response reached 72% in the high-dose group (n = 42) and 64% in the medium-dose group (n = 42), compared with 35% in the placebo group (n = 44), differences of 37 and 29 percentage points, respectively. In an exploratory analysis, 52% of the low-dose group (n = 21) responded, 17 points above placebo.¹
For the nonranked key secondary end points, HiSCR75 was achieved by 41%, 40%, and 29% of the high-, medium-, and low-dose groups, respectively, versus 15% with placebo.¹ DLQI scores fell from baseline by a mean of 5.62 points with the high dose and 3.50 points with the medium dose, compared with 2.46 points with placebo. The low dose showed no DLQI benefit over placebo. Merck characterized the secondary end point results as numerical improvements.¹
Alexa B. Kimball, MD, MPH, lead investigator and professor of dermatology at Harvard Medical School, noted many individuals fail to attain durable disease control despite existing advanced medication options. She said the results point to potential for meaningful improvement in managing this difficult-to-treat condition. Kimball is a paid consultant to Merck.¹
Adverse events occurred in 42.9%, 47.6%, and 52.4% of participants receiving high-, medium-, and low-dose tulisokibart, respectively, compared with 40.9% with placebo. Serious adverse events were infrequent, at 2.4% in the high- and medium-dose groups, 4.8% in the low-dose group, and 2.3% in the placebo group.¹
No serious or opportunistic infections occurred during the study.¹ Merck plans to use these data to guide phase 3 development of tulisokibart in HS. Aileen Pangan, vice president and therapeutic area head of immunology clinical research at Merck Research Laboratories, confirmed the company intends to advance the agent into phase 3 for this population.
The agent is also being evaluated in phase 3 research for ulcerative colitis and Crohn's disease and in phase 2 trials for rheumatoid arthritis, psoriatic arthritis, and radiographic axial spondyloarthritis.¹
Tulisokibart is not approved by any regulatory authority. Study group sizes were modest, and the low-dose arm enrolled half as many participants as the other arms.¹
Editor's Note: This summary has been edited for grammar and clarity using artificial intelligence tools.
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