ABTECT - Maintenance
Condition(s) studied
Investigational drug(s) / intervention(s)
ABX464: Administered once daily, preferably in the morning, with food
Placebo: Administered once daily, preferably in the morning, with food
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.
Eligibility
Primary outcome measure(s)
- Rate of subjects in clinical remission at Week 44 — Week 44
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. - Number and percentage of all treatment-emergent adverse events (TEAEs) — Week 44
The Part 2 primary objective is safety - Number and percentage of all serious adverse events (SAEs) — Week 44
The Part 2 primary objective is safety - Number and percentage of all causally related TEAEs/SAEs — Week 44
The Part 2 primary objective is safety
Trial sites (413)
| Facility | City | Region | Status |
|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | |
| Research Solutions of Arizona, PC | Litchfield Park | Arizona | |
| GI Alliance | Sun City | Arizona | |
| University of Arizona | Tucson | Arizona | |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | |
| Citrus Valley Gastroenterology | Covina | California | |
| University of California (San Diego) | La Jolla | California | |
| United Medical Doctors | Murrieta | California | |
| California Medical Research Associates Inc. | Northridge | California | |
| Clinnova Research Solutions | Orange | California | |
| Clinical Applications Laboratories | San Diego | California | |
| Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals | Aurora | Colorado | |
| Danbury Hospital | Danbury | Connecticut | |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | |
| Nature Coast Clinical Research, LLC | Inverness | Florida | |
| Auzmer Research | Lakeland | Florida | |
| Infinite Clinical Research Inc | Miami | Florida | |
| Research Associates of South Florida, LLC | Miami | Florida | |
| University of Miami | Miami | Florida | |
| MedOne Clinical Research LLC | Miami | Florida | |
| Nicklaus Children's Hospital | Miami | Florida | |
| Medical Professional Clinical Research Center | Miami | Florida | |
| Wellness Clinical Research | Miami Lakes | Florida | |
| Ocala GI Research | Ocala | Florida | |
| Arnold Palmer Hospital For Children | Orlando | Florida | |
| Advanced Research Institute, Inc. | Orlando | Florida | |
| GCP Clinical Research, LLC | Tampa | Florida | |
| Guardian Angel Research Center | Tampa | Florida | |
| Alliance Clinical Research | Tampa | Florida | |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | |
| University of Chicago Medical Center | Chicago | Illinois | |
| GI Alliance | Gurnee | Illinois | |
| Iowa Digestive Disease Center | Clive | Iowa | |
| The University of Iowa | Iowa City | Iowa | |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | |
| University of Maryland Medical Center | Baltimore | Maryland | |
| Boston Medical Center | Boston | Massachusetts | |
| Lucida Clinical Trials LLC | New Bedford | Massachusetts | |
| Henry Ford Hospital | Sterling Heights | Michigan |
+ 373 more sites — see the full list on the official registry below.
More Abivax S.A. trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05535946 on ClinicalTrials.gov ↗ ← All trials in the UK