ABTECT - Maintenance
Public ClinicalTrials.gov record NCT05535946. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05535946
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,116 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 16, 2023 (Actual)
- Primary completion
- Apr 28, 2026 (Actual)
- Completion
- May 2030 (Estimated)
- Last update posted
- Jul 7, 2026
2023 – 2030
United States locations
- U.S. sites
- 72
- U.S. states
- 29
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Research Solutions of Arizona, PC | Litchfield Park | Arizona | 85340 | — |
| GI Alliance | Sun City | Arizona | 85351 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205-7199 | — |
| Citrus Valley Gastroenterology | Covina | California | 91723 | — |
| University of California (San Diego) | La Jolla | California | 92093 | — |
| United Medical Doctors | Murrieta | California | 92563 | — |
| California Medical Research Associates Inc. | Northridge | California | 91324 | — |
| Clinnova Research Solutions | Orange | California | 92868 | — |
| Clinical Applications Laboratories | San Diego | California | 92103 | — |
| Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals | Aurora | Colorado | 80014 | — |
| Danbury Hospital | Danbury | Connecticut | 06810 | — |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33762 | — |
| Nature Coast Clinical Research, LLC | Inverness | Florida | 34452 | — |
| Auzmer Research | Lakeland | Florida | 33813 | — |
| Infinite Clinical Research Inc | Miami | Florida | 33133 | — |
| Research Associates of South Florida, LLC | Miami | Florida | 33134 | — |
| University of Miami | Miami | Florida | 33136 | — |
| MedOne Clinical Research LLC | Miami | Florida | 33145 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155-3009 | — |
| Medical Professional Clinical Research Center | Miami | Florida | 33165 | — |
| Wellness Clinical Research | Miami Lakes | Florida | 33016 | — |
| Ocala GI Research | Ocala | Florida | 34471 | — |
| Arnold Palmer Hospital For Children | Orlando | Florida | 32806 | — |
| Advanced Research Institute, Inc. | Orlando | Florida | 32825 | — |
| GCP Clinical Research, LLC | Tampa | Florida | 33609 | — |
| Guardian Angel Research Center | Tampa | Florida | 33614 | — |
| Alliance Clinical Research | Tampa | Florida | 33615 | — |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| GI Alliance | Gurnee | Illinois | 60031 | — |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | — |
| The University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Lucida Clinical Trials LLC | New Bedford | Massachusetts | 02740 | — |
| Henry Ford Hospital | Sterling Heights | Michigan | 48313 | — |
| Digestive Health Center PA | Ocean Springs | Mississippi | 39564 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | — |
| AIG Digestive Disease Research | Florham Park | New Jersey | 07932 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte | North Carolina | 28207 | — |
| Wilmington Health | Wilmington | North Carolina | 28401 | — |
| Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | — |
| Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Board of Regents of the University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| Frontier Clinical Research, LLC | Uniontown | Pennsylvania | 15401 | — |
| Columbia Digestive Health Research | Columbia | South Carolina | 29204 | — |
| Gastroenterology Associates, PA | Greenville | South Carolina | 29607 | — |
| Rapid City Medical Center, LLC | Rapid City | South Dakota | 57701 | — |
| Gastroenterology Center of the MidSouth PC | Germantown | Tennessee | 38138 | — |
| Central Texas Clinical Research, LLC | Austin | Texas | 78705 | — |
| Inquest Clinical Research | Baytown | Texas | 77521 | — |
| Texas Digestive Disease Consultants | Cedar Park | Texas | 78613 | — |
| Baylor Scott and White | Dallas | Texas | 75246 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College Of Medicine | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | — |
| GI Alliance - Southlake | Southlake | Texas | 76092 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Care Access Research LLC | Ogden | Utah | 84403 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Gastroenterology Consultants and Endoscopy Center of Southwest Virginia | Roanoke | Virginia | 24014 | — |
| TPMG Clinical Research Williamsburg | Williamsburg | Virginia | 23188 | — |
| The Vancouver Clinic | Vancouver | Washington | 98664 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 341 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05535946, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05535946 live on ClinicalTrials.gov.