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NCT03760003 · ClinicalTrials.gov registry record · Phase 2
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
A Phase 2 study, sponsored by Abivax S.A..
- Completed
- Registry status
- Phase 2
- Development phase
- 355
- Enrollment target
NCT03760003: Completed Phase 2 study, sponsored by Abivax S.A..
NCT03760003 is a Phase 2 study that has completed, run by Abivax S.A.. The registered enrollment target is 355 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (167% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03760003, a Phase 2 study, has completed, sponsored by Abivax S.A..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 355 participants
- Enrollment target
Study Summary
Phase 2b study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.
Primary Outcome
Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from
Interventions
- DRUG Placebo
- DRUG ABX464 100 mg
- DRUG ABX464 50 mg
- DRUG ABX464 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2021-04-16 |
| Phase | Phase 2 |
What the finished NCT03760003 record still lists
NCT03760003 is an interventional study that assigns participants to a tested intervention. The registered 355 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 (167% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03760003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03760003 about?
NCT03760003 is a clinical study titled "Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis". Phase 2b study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.
What is the current status of trial NCT03760003?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 355 participants. The study started on 2019-08-13. Estimated completion is 2021-04-16.
What interventions are being tested in trial NCT03760003?
The interventions under investigation include: Placebo (DRUG), ABX464 100 mg (DRUG), ABX464 50 mg (DRUG), ABX464 25 mg (DRUG).
Who is sponsoring clinical trial NCT03760003?
This trial is sponsored by Abivax S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03760003's enrollment target sits among peer trials
355 128th of 2000 higher than 1,873 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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