AT A GLANCE

A new study published in the Lancet Gastroenterology and Hepatology reveals that tulisokibart is well tolerated and potentially efficacious in moderately to severely active Crohn's disease.¹

“TNF-like cytokine 1A (TL1A) is a key mediator of inflammation and fibrosis,” explain study authors Feagan et al. In the present study, “the efficacy and safety of the anti-TL1A monoclonal antibody tulisokibart as induction treatment was assessed in adults with moderately to severely active Crohn's disease with a history of insufficient response, loss of response, or intolerance to conventional or approved biological therapies.”

As part of a phase 2a, multicenter, open-label study, the authors treated adult participants with moderately to severely active Crohn's disease with intravenous tulisokibart (1000 mg on Day 1 and 500 mg at Weeks 2, 6, and 10), then evaluated the results. The primary study endpoints of interest were safety and the proportion of participants with endoscopic response at Week 12, defined as a decrease in the Simple Endoscopy Score for Crohn's Disease (SES-CD) of at least 50% from baseline. Safety was analyzed in all participants treated with tulisokibart, while endoscopic response was analyzed in the per-protocol analysis set, which included all participants treated with tulisokibart with baseline Crohn's Disease Activity Index (CDAI) and SES-CD scores, except those with prespecified important protocol deviations.

Among 55 eligible participants finally enrolled, an endoscopic response was observed in 13 of 50 participants receiving tulisokibart in the per-protocol analysis set at Week 12. Adverse events occurred in 43 (78%) of 55 participants, with most adverse events being mild to moderate in severity; eight (15%) participants had serious adverse events, but none of which were considered related to the study drug by the investigator.

“This proof-of-concept study showed that tulisokibart is potentially efficacious in moderately to severely active Crohn's disease and is well tolerated. Randomized controlled trials with longer duration are needed to confirm these results; a double-blind, placebo-controlled, phase 3 trial is currently underway,” conclude the authors.

Reference

1.     Feagan BG, Sands BE, Siegel CA, et al. Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial. Lancet Gastroenterol Hepatol. 2025;10(8):715–725.