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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04857112

Public ClinicalTrials.gov record NCT04857112. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 10, 2026, 12:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04857112
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
322 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 29, 2021 (Actual)
Primary completion
Sep 3, 2024 (Actual)
Completion
Nov 8, 2024 (Actual)
Last update posted
Sep 9, 2025

2021 – 2024

United States locations

U.S. sites
22
U.S. states
11
U.S. cities
21
Facility City State ZIP Site status
Bausch Site 025 Chandler Arizona 85225 —
Salix Site 004 Los Angeles California 90048 —
Salix Site 003 Rancho Cucamonga California 91730 —
Salix Site 007 Rialto California 92377 —
Salix Site 006 Ventura California 93003 —
Bausch Site 013 Maitland Florida 32751 —
Bausch Site 024 Miami Florida 33174 —
Salix Site 005 Miramar Florida 33027 —
Bausch site 026 Orlando Florida 32807 —
Salix Site 010 Snellville Georgia 30078 —
Bausch Site 011 Chicago Illinois 60637 —
Bausch Site 020 Glenview Illinois 60026 —
Bausch Site 008 Lafayette Louisiana 70503 —
Bausch Site 022 Metairie Louisiana 70006 —
Salix Site 001 Shreveport Louisiana 71103 —
Salix Site 002 Freehold New Jersey 07728 —
Bausch Site 017 Mentor Ohio 44060 —
Bausch Site 021 Oklahoma City Oklahoma 73101 —
Bausch Site 014 El Paso Texas 79905 —
Bausch Site 018 Houston Texas 77030 —
Bausch Site 019 Houston Texas 77030 —
Bausch Site 012 Suffolk Virginia 23435 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 163 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04857112, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 9, 2025 · Synced Oct 10, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04857112 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →