ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
Public ClinicalTrials.gov record NCT05507216. 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, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment 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 efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission 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 \[biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors\].
Study identification
- NCT ID
- NCT05507216
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 636 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 25, 2023 (Actual)
- Primary completion
- Jun 24, 2025 (Actual)
- Completion
- Jul 15, 2025 (Actual)
- Last update posted
- Sep 10, 2026
2023 – 2025
United States locations
- U.S. sites
- 46
- U.S. states
- 20
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama -Birmingham | Birmingham | Alabama | 35205 | — |
| Research Solutions of Arizona, PC | Litchfield Park | Arizona | 85340 | — |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | — |
| National Institute of Clinical Research | Bakersfield | California | 93309 | — |
| Citrus Valley Gastroenterology | Covina | California | 91723 | — |
| United Medical Doctors | Murrieta | California | 92563 | — |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| Clinical Applications Laboratories | San Diego | California | 92103 | — |
| Santa Maria Gastroenterology Medical Group | Santa Maria | California | 93458 | — |
| Danbury Hospital | Danbury | Connecticut | 06810 | — |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33762 | — |
| IHS Health | Kissimmee | Florida | 34741 | — |
| Research Associates of South Florida | Miami | Florida | 33134 | — |
| Sanchez Clinical Research, Inc | Miami | Florida | 33157 | — |
| Wellness Clinical Research | Miami Lakes | Florida | 33016 | — |
| Sarkis Clinical Trials - Parent | Ocala | Florida | 34474 | — |
| AdventHealth Medical Group | Orlando | Florida | 32804 | — |
| Arnold Palmer Hospital For Children | Orlando | Florida | 32806 | — |
| Omega Research Orlando, LLC | Orlando | Florida | 32808 | — |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | — |
| GCP Clinical Research, LLC | Tampa | Florida | 33609 | — |
| University of South Florida - PARENT | Tampa | Florida | 33612 | — |
| The University of Iowa | Iowa City | Iowa | 52242 | — |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | — |
| Tandem Clinical Research, LLC | Marrero | Louisiana | 70072 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| BVL Clinical Research | Liberty | Missouri | 64068 | — |
| Premier Health Research | Sparta | New Jersey | 07871 | — |
| NY Scientific Corp. | Brooklyn | New York | 11235 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Plains Clinical Research Center, LLC | Fargo | North Dakota | 58104 | — |
| Susquehanna Research Group, LLC | Harrisburg | Pennsylvania | 17110 | — |
| Frontier Clinical Research, LLC | Uniontown | Pennsylvania | 15401 | — |
| Rapid City Medical Center, LLC | Rapid City | South Dakota | 57701 | — |
| Digestive Health Research, LC | Hermitage | Tennessee | 37076 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| Inquest Clinical Research | Baytown | Texas | 77521 | — |
| Gastroenterology Consultants of South Texas, PA | Harlingen | Texas | 78550 | — |
| Digestive System Healthcare | Pasadena | Texas | 77505 | — |
| LinQ Research, LLC | Pearland | Texas | 77584 | — |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78229 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75703 | — |
| Richmond VA Medical Center | Richmond | Virginia | 23249 | — |
| Gastroenterology Consultants and Endoscopy Center of Southwest Virginia | Roanoke | Virginia | 24014 | — |
| 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 216 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05507216, 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 Sep 10, 2026 · Synced Oct 21, 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 NCT05507216 live on ClinicalTrials.gov.