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NCT04857112 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 2
Development phase
322
Enrollment target

NCT04857112 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 322 participants.

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The verdict

NCT04857112, a Phase 2 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 2
Development phase
322 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Low Dose MT-1303
  • DRUG High Dose MT-1303
  • DRUG MT-1303

Trial Details

FieldValue
Enrollment Target 322 participants
Start Date 2021-09-29
Est. Completion 2024-11-08
Phase Phase 2

Sponsor

Bausch Health Americas

168 total trials

What the Registry Record Tells You About NCT04857112

The ClinicalTrials.gov registry entry for NCT04857112 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 322 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT04857112 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04857112 about?

NCT04857112 is a clinical study titled "Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis". 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.

What is the current status of trial NCT04857112?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 322 participants. The study started on 2021-09-29. Estimated completion is 2024-11-08.

What interventions are being tested in trial NCT04857112?

The interventions under investigation include: Placebo (DRUG), Low Dose MT-1303 (DRUG), High Dose MT-1303 (DRUG), MT-1303 (DRUG).

Who is sponsoring clinical trial NCT04857112?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.