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NCT05507203 · ClinicalTrials.gov registry record · Phase 3
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
A Phase 3 study, sponsored by Abivax S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 639
- Enrollment target
NCT05507203: Completed Phase 3 study, sponsored by Abivax S.A..
NCT05507203 is a Phase 3 study that has completed, run by Abivax S.A.. The registered enrollment target is 639 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05507203, a Phase 3 study, has completed, sponsored by Abivax S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 639 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies \[corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)\] and/or advanced therapies \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].
Primary Outcome
To compare the efficacy of ABX464 versus placebo on clinical remission
Interventions
- DRUG Placebo
- DRUG ABX464
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 639 participants |
| Start Date | 2022-10-10 |
| Est. Completion | 2025-06-25 |
| Phase | Phase 3 |
What the finished NCT05507203 record still lists
NCT05507203 is an interventional study that assigns participants to a tested intervention. The registered 639 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 (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05507203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05507203 about?
NCT05507203 is a clinical study titled "ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1". This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an into...
What is the current status of trial NCT05507203?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 639 participants. The study started on 2022-10-10. Estimated completion is 2025-06-25.
What interventions are being tested in trial NCT05507203?
The interventions under investigation include: Placebo (DRUG), ABX464 (DRUG).
Who is sponsoring clinical trial NCT05507203?
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 NCT05507203's enrollment target sits among peer trials
639 579th of 2000 higher than 1,422 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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