Merck’s tulisokibart met primary and key secondary endpoints in the Phase 3 ATLAS-UC induction-only study in patients with moderately to severely active ulcerative colitis

Merck has officially shared positive topline results from the Phase 3 ATLAS-UC induction-only study evaluating tulisokibart, an investigational humanized monoclonal antibody directed at tumor necrosis factor-like cytokine 1A, in patients living with moderately to severely active ulcerative colitis. The study cleared its primary endpoint of clinical remission according to the Modified Mayo Score at week 12, and all key secondary endpoints were also achieved. No new safety concerns arose, consistent with what had been observed in earlier Phase 2 work.

“These positive Phase 3 induction results for tulisokibart are the first for an anti-TL1A biologic. They represent an important step forward for patients with moderately to severely active ulcerative colitis who, despite available treatments, continue to experience symptoms, and do not achieve clinical remission,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “These results reinforce the potential of this novel approach designed to help address immuno-fibrosis, a key driver of chronic immune dysregulation and disease progression in ulcerative colitis.”

Findings from ATLAS-UC Study 2 will be presented alongside results from the ongoing induction and maintenance study at a forthcoming scientific congress, and will also be submitted to regulatory authorities.

Tulisokibart carries the broadest development programme within the emerging anti-TL1A class and is currently being assessed across seven disease indications. At Phase 3 level, the ATLAS-UC trial is examining the therapy in ulcerative colitis, while the ARES-CD trial is evaluating it in Crohn’s disease. At Phase 2 level, tulisokibart is being studied across a further five conditions: systemic sclerosis-associated interstitial lung disease, rheumatoid arthritis, psoriatic arthritis, radiographic axial spondyloarthritis, and hidradenitis suppurativa.

---

---

Related Topics and Keywords

Merck, Phase 3 ATLAS-UC induction, severely active ulcerative colitis, ulcerative colitis