NCT04857112

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

A Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Low Dose MT-1303	MT-1303 loading dose of 0.4 mg once daily (QD) (Day 1-14) then maintenance dose of 0.2 mg QD (Day 15-85)
DRUG	High Dose MT-1303	MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)
DRUG	Placebo	Matching placebo, QD (Day 1-85)
DRUG	MT-1303	0.4 mg MT-1303 QD for 36 weeks for those participants who continue on to the OLE period from the double-blind portion of the clinical study

Timeline

• Start date: 2021-09-29
• Primary completion: 2024-09-03
• Completion: 2024-11-08
• First posted: 2021-04-23
• Last updated: 2025-09-09

Locations

185 sites across 19 countries: United States, Australia, Belarus, Bulgaria, Czechia, Estonia, Georgia, Germany, Hungary, Italy, Japan, Moldova, Poland, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study