Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05507216 · ClinicalTrials.gov registry record · Phase 3
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
A Phase 3 study, sponsored by Abivax S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 636
- Enrollment target
NCT05507216 is a Phase 3 study that has completed, run by Abivax S.A.. The registered enrollment target is 636 participants.
The verdict
NCT05507216, a Phase 3 study, has completed, sponsored by Abivax S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 636 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 \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].
Interventions
- DRUG Placebo
- DRUG ABX464
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 636 participants |
| Start Date | 2022-12-21 |
| Est. Completion | 2025-07-15 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05507216
The ClinicalTrials.gov registry entry for NCT05507216 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 636 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abivax S.A., which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05507216 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05507216 about?
NCT05507216 is a clinical study titled "ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2". 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 NCT05507216?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 636 participants. The study started on 2022-12-21. Estimated completion is 2025-07-15.
What interventions are being tested in trial NCT05507216?
The interventions under investigation include: Placebo (DRUG), ABX464 (DRUG).
Who is sponsoring clinical trial NCT05507216?
This trial is sponsored by Abivax S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.