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Clinical Trial 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.

Clinical Trial Description

This is a Phase 2, randomized, double-blinded, placebo-controlled 3-arm, multi-center, parallel-group study with an open-label extension (OLE) period. The study includes a Screening Period (of up to 28 days) and a 12-week Double-Blind Period (Day 1 through Day 85) for all subjects. Subjects completing the Double-Blind Period through Day 85 will be provided the opportunity to continue in the OLE Period of the study to receive treatment through approximately one year. Subjects who do not participate in the OLE Period will be followed for 84 days in a Safety Follow-up Period. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04857112
Study type Interventional
Source Bausch Health Americas, Inc.
Contact Alison Magnotti-Nagel
Phone 9085418664
Email [email protected]
Status Recruiting
Phase Phase 2
Start date May 2021
Completion date October 2023

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