drugset / Trial / NCT04857112

Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis

NCT04857112

Phase 2 Completed 322 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.

Timeline

Start
2021-09-29
Primary completion
2024-09-03
Completion
2024-11-08

Drugs

EvaluationDrugModalityDoseRoute
Subject amiselimod Small molecule 0.2 mg Oral
Subject amiselimod Small molecule 0.4 mg Oral

Indications