ABTECT - Maintenance (NCT05535946)
A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Digestive Health Specialists of the Southeast — Dothan, Alabama
Age range: 16 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (413 Sites)
Showing the first 25 of 413 sites.
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ulcerative Colitis
- A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) — Dothan, Alabama
- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis — San Diego, California
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants — Eden Prairie, Minnesota
- CP101 for the Treatment of Ulcerative Colitis — Boston, Massachusetts
- A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis — Los Angeles, California
- Angiographic Delivery of AD-MSC for Ulcerative Colitis — Rochester, Minnesota
Explore by condition: All Ulcerative Colitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.