Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
ClinicalTrials.gov ID: NCT04857112
Sponsor: Bausch Health Americas, Inc.
Information provided by: Bausch Health Americas, Inc. (Responsible Party)
Last Update Posted: 2023-07-27
Brief 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.
OFFICIAL TITLE
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)
INTERVENTION / TREATMENT
Drug: Low Dose MT-1303
Drug: High Dose MT-1303
Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2021-09-29 |
| Primary Completion (Estimated) | 2023-10 |
| Study Completion (Estimated) | 2023-10 |
| Enrollment (Estimated) | 336 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
AMUC-2023
|