Phase IIA Trial: Tulisokibart Brings Nearly Half of Crohn's Disease Patients Into Remission
Crohn's disease is a chronic inflammatory bowel condition that affects the entire digestive tract and currently has no cure. Patients often cycle through multiple treatments, including biologics and immunosuppressants, seeking relief from debilitating symptoms like abdominal pain, diarrhea, and fatigue. Now, a promising new therapy developed at Cedars-Sinai Medical Center is offering fresh hope: an investigational monoclonal antibody called tulisokibart that brought nearly half of patients with moderate-to-severe Crohn's disease into clinical remission in a Phase II-A clinical trial.
The study, called APOLLO-CD, enrolled 55 adults with active Crohn's disease and administered tulisokibart in varying doses over 12 weeks. Results showed that nearly 50% of patients achieved clinical remission, a striking contrast to the roughly 16% remission rate seen in historical control studies. The findings were published in The Lancet Gastroenterology and Hepatology in June 2025, and the research team behind the work includes leading IBD geneticist Dermot McGovern, MD, PhD, alongside Stephan Targan, MD, and Janine Bilsborough, PhD, all of whom dedicated years to studying the biological pathway tulisokibart targets.
What makes tulisokibart particularly notable is the protein it blocks: TL1A, which plays a central role in both inflammation and fibrosis in the gut. Fibrosis, the build-up of scar tissue that causes intestinal narrowing, is one of the most serious and currently untreatable complications of Crohn's disease. There is no existing therapy that can prevent or reverse this process, but early data from APOLLO-CD suggests tulisokibart may have this capability, adding a layer of potential benefit that goes well beyond symptom control. Researchers are also watching whether the drug's anti-fibrotic effects could eventually prove useful in other chronic conditions where fibrosis drives serious complications.
Speed is another advantage that caught researchers' attention. Patients' inflammatory markers began to drop within just one week of starting treatment, which is notably faster than many existing therapies. For someone living with active Crohn's disease, faster symptom control can mean a faster return to work, relationships, and ordinary daily life. The development of a companion diagnostic test designed to identify which patients are most likely to benefit from tulisokibart adds another forward-looking dimension to this research, moving toward a precision medicine model where clinicians can match the right drug to the right patient from the start. Phase III trials are now underway in larger populations of both Crohn's disease and ulcerative colitis patients.
Source: Cedars-Sinai Medical Center, June 26, 2025. McGovern D, Targan S, Bilsborough J, et al. Study: Crohn's Disease Investigational Treatment Shows Potential for Achieving Remission. This article is for informational purposes only and does not constitute medical advice. Consult your healthcare provider for guidance specific to your situation.