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NCT05535946 · ClinicalTrials.gov registry record · Phase 3
ABTECT - Maintenance
A Phase 3 study of Ulcerative Colitis, sponsored by Abivax S.A..
- Active
- Registry status
- Phase 3
- Development phase
- 1,116
- Enrollment target
- 20
- Study locations
NCT05535946: Active Phase 3 study of Ulcerative Colitis, sponsored by Abivax S.A..
NCT05535946 is a Phase 3 study of Ulcerative Colitis that is active but no longer recruiting, run by Abivax S.A.. The registered enrollment target is 1,116 participants, below the 2,048-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05535946, a Phase 3 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Abivax S.A..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,116 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy 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 \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106.
Primary Outcome
The Part 1 primary objective is to compare the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission \[SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1\] at Week 44.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ABX464
Study Locations (20)
California
- National Institute of Clinical Research - Bakersfield
- Kindred Medical Institute for Clinical Trials, LLC - Corona
- Aurora Care Clinic - Costa Mesa
- Citrus Valley Gastroenterology - Covina
- University of California (San Diego) - La Jolla
- Gastro Care Institute - Lancaster
- United Medical Doctors - Murrieta
- Hoag Memorial Hospital Presbyterian - Newport Beach
- California Medical Research Associates Inc. - Northridge
- Clinnova Research Solutions - Orange
Arizona
- Research Solutions of Arizona, PC - Litchfield Park
- Valleywise Health Medical Center - Phoenix
- GI Alliance - Sun City
- Del Sol Research Management, LLC - Tucson
- University of Arizona - Tucson
Alabama
- University of Alabama -Birmingham - Birmingham
- Digestive Health Specialists of the Southeast - Dothan
- Lakeview Clinical Research - Guntersville
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
- Applied Research Center of Arkansas - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,116 participants |
| Start Date | 2023-01-16 |
| Est. Completion | 2030-05 |
| Phase | Phase 3 |
What the registry record for NCT05535946 still lists
NCT05535946 is an interventional study that assigns participants to a tested intervention. Its 1,116 participants enrollment target places it among the larger protocols in the corpus, below the 2,048-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05535946 names 20 study sites across 4 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05535946 about?
NCT05535946 is a clinical study titled "ABTECT - Maintenance". This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of...
What is the current status of trial NCT05535946?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,116 participants. The study started on 2023-01-16. Estimated completion is 2030-05.
What conditions does trial NCT05535946 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT05535946?
The interventions under investigation include: Placebo (DRUG), ABX464 (DRUG).
Who is sponsoring clinical trial NCT05535946?
This trial is sponsored by Abivax S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05535946 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05535946's enrollment target sits among peer trials
1,116 7th of 122 higher than 116 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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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