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Completed Phase 3 Interventional

ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2

ClinicalTrials.gov ID: NCT05507216

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.

ClinicalTrials.gov public records Last synced May 20, 2026, 2:30 AM EDT

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

Study identification

NCT ID
NCT05507216
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Abivax S.A.
Industry
Enrollment
636 participants

Conditions and interventions

Interventions

  • ABX464 Drug
  • Placebo Drug

Drug

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
Dec 20, 2022
Primary completion
Jun 23, 2025
Completion
Jul 14, 2025
Last update posted
Oct 23, 2025

2022 – 2025

United States locations

U.S. sites
61
U.S. states
26
U.S. cities
52
Facility City State ZIP Site status
University of Alabama -Birmingham Birmingham Alabama 35205
Research Solutions of Arizona, PC Litchfield Park Arizona 85340
Valleywise Health Medical Center Phoenix Arizona 85008
Reliance Research Scottsdale Arizona 85260
Applied Research Center of Arkansas Little Rock Arkansas 72212
National Institute of Clinical Research Bakersfield California 93309
Kindred Medical Institute for Clinical Trials, LLC Corona California 92879
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
Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals Aurora Colorado 80014
Danbury Hospital Danbury Connecticut 06810
Medical Research Center of Connecticut, LLC Hamden Connecticut 06518
West Central Gastroenterology d/b/a Gastro Florida Clearwater Florida 33762
Superior Associates in Research Hialeah Florida 33012
IHS Health Kissimmee Florida 34741
Infinite Clinical Research Inc Miami Florida 33133
Research Associates of South Florida Miami Florida 33134
Nicklaus Children's Hospital Miami Florida 33155-3009
Sanchez Clinical Research, Inc Miami Florida 33157
Reliant Medical Research, LLC Miami Florida 33165
Ocala GI Research Ocala Florida 34471
Sarkis Clinical Trials - Parent Ocala Florida 34474
Arnold Palmer Hospital For Children Orlando Florida 32806
Omega Research Orlando, LLC Orlando Florida 32808
GCP Clinical Research, LLC Tampa Florida 33609
Guardian Angel Research Center Tampa Florida 33614
Alliance Clinical Research Tampa Florida 33615
Iowa Digestive Disease Center Clive Iowa 50325
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 Maryland Medical Center Baltimore Maryland 21201
NECCR Primacare Research, LLC Fall River Massachusetts 02721
University of Michigan Ann Arbor Michigan 48109
Clinical Research Institute of Michigan, LLC Chesterfield Michigan 48047
Michigan Center of Medical Research Farmington Hills Michigan 48334
Gastrointestinal Associates, PA Flowood Mississippi 39232
BVL Clinical Research Liberty Missouri 64068
AIG Digestive Disease Research Florham Park New Jersey 07932
NY Scientific Corp. Brooklyn New York 11235
Mount Sinai New York New York 10029
Plains Clinical Research Center, LLC Fargo North Dakota 58104
University Hospitals Cleveland Medical Center Cleveland Ohio 44106
Hightower Clinical Oklahoma City Oklahoma 73102
Board of Regents of the University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104
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
Vanderbilt University Medical Center Nashville Tennessee 37232
Texas Clinical Research Institute, LLC Arlington Texas 76012
Inquest Clinical Research Baytown Texas 77521
Valley Institute of Research Fort Worth Texas 76164
Mt.Olympus Medical Research Katy Texas 77494
Digestive System Healthcare Pasadena Texas 77505
LinQ Research, LLC Pearland Texas 77584
Tyler Research Institute, LLC Tyler Texas 75703
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 212 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 Oct 23, 2025 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05507216 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →