drugset / Trial / NCT06095128

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

NCT06095128

Phase 4 Recruiting 65 enrolled Takeda
NaSingle-groupOpen-labelTreatment

Summary

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.

Timeline

Start
2024-06-12
Primary completion
2027-07-09
Completion
2027-07-09

Drugs

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

Indications