ABTECT - Maintenance
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
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.
Key facts
- Study ID
- NCT05535946
- Run by
- Abivax S.A.
- People needed
- 1116
- Starts
- 2023-01-16
- Expected to finish
- 2030-05-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Solutions of Arizona, PC — Litchfield Park, Arizona, United States
- GI Alliance — Sun City, Arizona, United States
- University of Arizona — Tucson, Arizona, United States
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Citrus Valley Gastroenterology — Covina, California, United States
- University of California (San Diego) — La Jolla, California, United States
- United Medical Doctors — Murrieta, California, United States
- California Medical Research Associates Inc. — Northridge, California, United States
- Clinnova Research Solutions — Orange, California, United States
- Clinical Applications Laboratories — San Diego, California, United States
- Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals — Aurora, Colorado, United States
- Danbury Hospital — Danbury, Connecticut, United States
- West Central Gastroenterology d/b/a Gastro Florida — Clearwater, Florida, United States
- Nature Coast Clinical Research, LLC — Inverness, Florida, United States
- Auzmer Research — Lakeland, Florida, United States
- Infinite Clinical Research Inc — Miami, Florida, United States
- Research Associates of South Florida, LLC — Miami, Florida, United States
- University of Miami — Miami, Florida, United States
- MedOne Clinical Research LLC — Miami, Florida, United States
- Nicklaus Children's Hospital — Miami, Florida, United States
- Medical Professional Clinical Research Center — Miami, Florida, United States
- Wellness Clinical Research — Miami Lakes, Florida, United States
- Ocala GI Research — Ocala, Florida, United States
- Arnold Palmer Hospital For Children — Orlando, Florida, United States
- Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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