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NCT03759041 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
A Phase 2 study, sponsored by Seres Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 203
- Enrollment target
NCT03759041: Clinical Trial Phase 2 study, sponsored by Seres Therapeutics.
NCT03759041 is a Phase 2 study that was terminated before completion, run by Seres Therapeutics. The registered enrollment target is 203 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03759041, a Phase 2 study, was terminated before completion, sponsored by Seres Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 203 participants
- Enrollment target
Study Summary
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis
Primary Outcome
Clinical remission for the induction treatment period: * Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline * Rectal Bleeding subscore = 0 * Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline * No occurrence of UC Flare during the treatment period Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. Th
Interventions
- DRUG SER-287
- DRUG Vancomycin Pre-Treatment
- DRUG Placebo for Vancomycin Pre-Treatment
- DRUG Placebo for SER-287
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2018-12-19 |
| Est. Completion | 2021-10-13 |
| Phase | Phase 2 |
Why NCT03759041 stopped before completion
NCT03759041 is an interventional study that assigns participants to a tested intervention. The registered 203 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 (53% higher).
The record links to 0 conditions, and to 4 interventions - of which SER-287 is the first listed.
NCT03759041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03759041 about?
NCT03759041 is a clinical study titled "A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis". A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis
What is the current status of trial NCT03759041?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 203 participants. The study started on 2018-12-19. Estimated completion is 2021-10-13.
What interventions are being tested in trial NCT03759041?
The interventions under investigation include: SER-287 (DRUG), Vancomycin Pre-Treatment (DRUG), Placebo for Vancomycin Pre-Treatment (DRUG), Placebo for SER-287 (DRUG).
Who is sponsoring clinical trial NCT03759041?
This trial is sponsored by Seres Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03759041's enrollment target sits among peer trials
203 301st of 2000 higher than 1,700 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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