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: Completed Phase 3 study, sponsored by Abivax S.A..
NCT05507216 is a Phase 3 study that has completed, run by Abivax S.A.. The registered enrollment target is 636 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
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 \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].
Primary Outcome
To compare the efficacy of ABX464 versus placebo on clinical remission
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 |
What the finished NCT05507216 record still lists
NCT05507216 is an interventional study that assigns participants to a tested intervention. The registered 636 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 (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05507216 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05507216's enrollment target sits among peer trials
636 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03821129 · 636 participants · NA
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
- NCT03478826 · 635 participants
Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
- NCT00573027 · 634 participants · NA
Heart Disease of the Small Arteries in Women and Men
- NCT04108156 · 634 participants · Phase 3
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI