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NCT03945188 · ClinicalTrials.gov registry record · Phase 3
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
A Phase 3 study, sponsored by Arena Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 433
- Enrollment target
NCT03945188: Completed Phase 3 study, sponsored by Arena Pharmaceuticals.
NCT03945188 is a Phase 3 study that has completed, run by Arena Pharmaceuticals. The registered enrollment target is 433 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03945188, a Phase 3 study, has completed, sponsored by Arena Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 433 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Primary Outcome
Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS
Interventions
- DRUG Placebo
- DRUG Etrasimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2019-06-13 |
| Est. Completion | 2022-02-16 |
| Phase | Phase 3 |
What the finished NCT03945188 record still lists
NCT03945188 is an interventional study that assigns participants to a tested intervention. The registered 433 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03945188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03945188 about?
NCT03945188 is a clinical study titled "Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
What is the current status of trial NCT03945188?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 433 participants. The study started on 2019-06-13. Estimated completion is 2022-02-16.
What interventions are being tested in trial NCT03945188?
The interventions under investigation include: Placebo (DRUG), Etrasimod (DRUG).
Who is sponsoring clinical trial NCT03945188?
This trial is sponsored by Arena Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03945188's enrollment target sits among peer trials
433 876th of 2000 higher than 1,125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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