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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: Completed Phase 2 study, sponsored by Bausch Health Americas.
NCT04857112 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 322 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (142% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The modified Mayo Score for ulcerative colitis disease activity provides an assessment of disease severity and can be used to monitor subjects during therapy. Scoring is accomplished by summation of subscores for endoscopic findings, stool frequency, and rectal bleeding, with higher scores indicating worse severity. Each subscore ranges from 0 to 3. The modified Mayo Score is defined as the sum of the endoscopy findings subscore + stool frequency subscore + rectal bleeding subscore, with a range
Interventions
- DRUG Placebo
- DRUG Low Dose MT-1303
- DRUG High Dose MT-1303
- DRUG MT-1303
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2024-11-08 |
| Phase | Phase 2 |
What the finished NCT04857112 record still lists
NCT04857112 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (142% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04857112 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04857112's enrollment target sits among peer trials
322 150th of 2000 higher than 1,850 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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