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ABTECT - Maintenance
NCT05535946 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05535946
The ClinicalTrials.gov registry entry for NCT05535946 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abivax S.A., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05535946 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05535946?
The interventions under investigation include: Placebo (DRUG), ABX464 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05535946?
This trial is sponsored by Abivax S.A., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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