drugset / Trial / NCT07297069

Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial

NCT07297069

Phase 2 Not yet recruiting 60 enrolled Asian Institute of Gastroenterology, India
RandomizedParallel-groupOpen-labelTreatment

Summary

In adults hospitalized with acute severe ulcerative colitis who fail to respond to intravenous steroids, does treatment with a combination of infliximab and tofacitinib, compared with infliximab alone or tofacitinib alone, result in higher rates of early clinical remission and mucosal healing, and fewer treatment-related complications over a 10 week period

Timeline

Start
2026-01-01
Primary completion
2027-05-31
Completion
2027-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 300 mg Intravenous
Subject Tofacitinib Small molecule 10 mg Oral

Indications