ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
Public ClinicalTrials.gov record NCT05507203. 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
- NCT05507203
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 639 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
- Nov 16, 2022 (Actual)
- Primary completion
- Jun 24, 2025 (Actual)
- Completion
- Jun 25, 2025 (Actual)
- Last update posted
- Sep 10, 2026
2022 – 2025
United States locations
- U.S. sites
- 54
- U.S. states
- 19
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Lakeview Clinical Research | Guntersville | Alabama | 35976 | — |
| Birmingham Digestive Health Research | Homewood | Alabama | 35209 | — |
| GI Alliance | Sun City | Arizona | 85351 | — |
| Del Sol Research Management, LLC | Tucson | Arizona | 85715 | — |
| Gastro Care Institute | Lancaster | California | 93534 | — |
| California Medical Research Associates Inc. | Northridge | California | 91324 | — |
| Clinnova Research Solutions | Orange | California | 92868 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Clinical Research Of Brandon, LLC | Brandon | Florida | 33511 | — |
| Access Research Institute | Brooksville | Florida | 34613 | — |
| Nature Coast Clinical Research - Inverness | Inverness | Florida | 34452 | — |
| Auzmer Research | Lakeland | Florida | 33813 | — |
| Medical Professional Clinical Research Center | Miami | Florida | 33165 | — |
| Advanced Research Institute, Inc. | New Port Richey | Florida | 34653 | — |
| Endoscopic Research, Inc. | Orlando | Florida | 32803 | — |
| Orlando Health-Orlando Regional Medical Center | Orlando | Florida | 32806 | — |
| Advanced Research Institute, Inc. | Orlando | Florida | 32825 | — |
| Gastroenterology Associates of Pensacola, PA | Pensacola | Florida | 32503 | — |
| Theia Clinical Research Centers, LLC | Temple Terrace | Florida | 33617 | — |
| One Health Research Clinic Atlanta, LLC | Norcross | Georgia | 30093 | — |
| Eagle Clinical Research | Chicago | Illinois | 60621 | — |
| GI Alliance | Glenview | Illinois | 60026 | — |
| GI Alliance | Gurnee | Illinois | 60031 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | — |
| Lucida Clinical Trials LLC | New Bedford | Massachusetts | 02740 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte | North Carolina | 28207 | — |
| Care Access Research Lumberton | Lumberton | North Carolina | 28358 | — |
| Wexner Medical Center | Columbus | Ohio | 43210 | — |
| DSI Research LLC | Springboro | Ohio | 45066 | — |
| Gastroenterology Center of the MidSouth PC | Germantown | Tennessee | 38138 | — |
| GI Alliance - Southlake | Austin | Texas | 76092 | — |
| Central Texas Clinical Research, LLC | Austin | Texas | 78705 | — |
| Novel Research LLC | Bellaire | Texas | 77401 | — |
| Texas Digestive Disease Consultants | Cedar Park | Texas | 78613 | — |
| Baylor Scott and White | Dallas | Texas | 75246 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| GI Alliance - Garland | Garland | Texas | 75044 | — |
| Baylor College Of Medicine | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Biopharma Informatic, Inc. Research Center | Houston | Texas | 77043 | — |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | — |
| Gastro Health & Nutrition | Katy | Texas | 78754 | — |
| Lubbock Digestive Disease Associates | Lubbock | Texas | 79410 | — |
| GI Alliance -Gurnee | Mansfield | Texas | 76063 | — |
| Digestive Research of Central Texas, LLC | Waco | Texas | 76301 | — |
| GI Alliance - Webster | Webster | Texas | 77598 | — |
| Care Access Research LLC | Ogden | Utah | 84403 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | — |
| University of Washington | Seattle | Washington | 98195 | — |
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 210 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05507203, 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 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05507203 live on ClinicalTrials.gov.