ACTIVE_NOT_RECRUITING

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Conditions

Ulcerative Colitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-01-16
Study Completion:2030-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05535946

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Severine Vermeire, MD, PhD
PRINCIPAL_INVESTIGATOR
UZ Leuven, Belgium
Bruce Sands, MD, PhD
PRINCIPAL_INVESTIGATOR
Mount Sinai Health System Digestive Disease Institute, New York USA

Study Locations (Sites)

University of Alabama -Birmingham
Birmingham, Alabama, 35233
United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
United States
Lakeview Clinical Research
Guntersville, Alabama, 35976
United States
Research Solutions of Arizona, PC
Litchfield Park, Arizona, 85340
United States
Valleywise Health Medical Center
Phoenix, Arizona, 85008
United States
GI Alliance
Sun City, Arizona, 85351
United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715
United States
University of Arizona
Tucson, Arizona, 85724
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205-7199
United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
United States
National Institute of Clinical Research
Bakersfield, California, 93309
United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879
United States
Aurora Care Clinic
Costa Mesa, California, 92627
United States
Citrus Valley Gastroenterology
Covina, California, 91723
United States
University of California (San Diego)
La Jolla, California, 92093
United States
Gastro Care Institute
Lancaster, California, 93534
United States
United Medical Doctors
Murrieta, California, 92563
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
California Medical Research Associates Inc.
Northridge, California, 91324
United States
Clinnova Research Solutions
Orange, California, 92868
United States
Clinical Applications Laboratories
San Diego, California, 92103
United States
Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals
Aurora, Colorado, 80014
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
United States
Danbury Hospital
Danbury, Connecticut, 06810
United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518
United States
Clinical Research Of Brandon, LLC
Brandon, Florida, 33511
United States
Access Research Institute
Brooksville, Florida, 34613
United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, 33762
United States
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452
United States
I.H.S Health, LLC
Kissimmee, Florida, 34741
United States
Auzmer Research
Lakeland, Florida, 33813
United States
Cfagi, Llc
Maitland, Florida, 32751
United States
Infinite Clinical Research Inc
Miami, Florida, 33133
United States
Research Associates of South Florida, LLC
Miami, Florida, 33134
United States
University of Miami
Miami, Florida, 33136
United States
MedOne Clinical Research LLC
Miami, Florida, 33145
United States
Nicklaus Children's Hospital
Miami, Florida, 33155-3009
United States
Sanchez Clinical Research, Inc
Miami, Florida, 33157
United States
Medical Professional Clinical Research Center
Miami, Florida, 33165
United States
Reliant Medical Research, LLC
Miami, Florida, 33165
United States
Wellness Clinical Research
Miami Lakes, Florida, 33016
United States
Ocala GI Research
Ocala, Florida, 34471
United States
Sarkis Clinical Trials - Parent
Ocala, Florida, 34474
United States
Endoscopic Research, Inc.
Orlando, Florida, 32803
United States
Arnold Palmer Hospital For Children
Orlando, Florida, 32806
United States
Omega Research Orlando, LLC
Orlando, Florida, 32808
United States
Advanced Research Institute, Inc.
Orlando, Florida, 32825
United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503
United States
Advanced Research Institute, Inc.
St. Petersburg, Florida, 33710
United States
Genesis Clinical Research
Tampa, Florida, 33606
United States
GCP Clinical Research, LLC
Tampa, Florida, 33609
United States
Guardian Angel Research Center
Tampa, Florida, 33614
United States
Alliance Clinical Research
Tampa, Florida, 33615
United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033
United States
One Health Research Clinic Atlanta, LLC
Norcross, Georgia, 30093
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
United States
Eagle Clinical Research
Chicago, Illinois, 60621
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
GI Alliance
Glenview, Illinois, 60026
United States
GI Alliance
Gurnee, Illinois, 60031
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
Iowa Digestive Disease Center
Clive, Iowa, 50325
United States
The University of Iowa
Iowa City, Iowa, 52242
United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
United States
University of Louisville Research Foundation
Louisville, Kentucky, 40202
United States
GI Alliance - Baton Rouge
Baton Rouge, Louisiana, 70809
United States
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
NECCR Primacare Research, LLC
Fall River, Massachusetts, 02721
United States
Lucida Clinical Trials LLC
New Bedford, Massachusetts, 02740
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
United States
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334
United States
Henry Ford Hospital
Sterling Heights, Michigan, 48313
United States
Gastrointestinal Associates, PA
Flowood, Mississippi, 39232
United States
Digestive Health Center PA
Ocean Springs, Mississippi, 39564
United States
BVL Clinical Research
Liberty, Missouri, 64068
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234
United States
AIG Digestive Disease Research
Florham Park, New Jersey, 07932
United States
NY Scientific Corp.
Brooklyn, New York, 11235
United States
Mount Sinai
New York, New York, 10029
United States
Rochester Clinical Research
Rochester, New York, 14609
United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, 28207
United States
Care Access Research Lumberton
Lumberton, North Carolina, 28358
United States
Wilmington Health
Wilmington, North Carolina, 28401
United States
Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, 58104
United States
Gastro Health Research
Cincinnati, Ohio, 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Wexner Medical Center
Columbus, Ohio, 43210
United States
DSI Research LLC
Springboro, Ohio, 45066
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102
United States
Board of Regents of the University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110
United States
UPMC
Pittsburgh, Pennsylvania, 15213
United States
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401
United States
Columbia Digestive Health Research
Columbia, South Carolina, 29204
United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29607
United States
Rapid City Medical Center, LLC
Rapid City, South Dakota, 57701
United States
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee, 38138
United States
Digestive Health Research, LC
Hermitage, Tennessee, 37076
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
United States
Central Texas Clinical Research, LLC
Austin, Texas, 78705
United States
Amel Med LLC
Austin, Texas, 78750
United States
Inquest Clinical Research
Baytown, Texas, 77521
United States
Texas Digestive Disease Consultants
Cedar Park, Texas, 78613
United States
Baylor Scott and White
Dallas, Texas, 75246
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Valley Institute of Research
Fort Worth, Texas, 76164
United States
GI Alliance - Garland
Garland, Texas, 75044
United States
Baylor College Of Medicine
Houston, Texas, 77030
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Biopharma Informatic, Inc. Research Center
Houston, Texas, 77043
United States
Biopharma Informatic, LLC
Houston, Texas, 77084
United States
Gastro Health & Nutrition
Katy, Texas, 77494
United States
Mt.Olympus Medical Research
Katy, Texas, 77494
United States
Digestive System Healthcare
Pasadena, Texas, 77505
United States
LinQ Research, LLC
Pearland, Texas, 77584
United States
GI Alliance - San Marcos
San Marcos, Texas, 78130
United States
GI Alliance - Southlake
Southlake, Texas, 76092
United States
Texas Gastroenterology Associates
Spring, Texas, 77386
United States
Tyler Research Institute, LLC
Tyler, Texas, 75701
United States
GI Alliance - Webster
Webster, Texas, 77598
United States
Care Access Research LLC
Ogden, Utah, 84403
United States
University of Utah
Salt Lake City, Utah, 84112
United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
United States
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia, 24014
United States
TPMG Clinical Research Williamsburg
Williamsburg, Virginia, 23188
United States
University of Washington
Seattle, Washington, 98195
United States
The Vancouver Clinic
Vancouver, Washington, 98664
United States

Collaborators and Investigators

Sponsor: Abivax S.A.

  • Severine Vermeire, MD, PhD, PRINCIPAL_INVESTIGATOR, UZ Leuven, Belgium
  • Bruce Sands, MD, PhD, PRINCIPAL_INVESTIGATOR, Mount Sinai Health System Digestive Disease Institute, New York USA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-16
Study Completion Date2030-05

Study Record Updates

Study Start Date2023-01-16
Study Completion Date2030-05

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis