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.
Ulcerative Colitis
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.
ABTECT - Maintenance
-
University of Alabama -Birmingham, Birmingham, Alabama, United States, 35233
Digestive Health Specialists of the Southeast, Dothan, Alabama, United States, 36305
Lakeview Clinical Research, Guntersville, Alabama, United States, 35976
Research Solutions of Arizona, PC, Litchfield Park, Arizona, United States, 85340
Valleywise Health Medical Center, Phoenix, Arizona, United States, 85008
GI Alliance, Sun City, Arizona, United States, 85351
Del Sol Research Management, LLC, Tucson, Arizona, United States, 85715
University of Arizona, Tucson, Arizona, United States, 85724
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205-7199
Applied Research Center of Arkansas, Little Rock, Arkansas, United States, 72212
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.
For general information about clinical research, read Learn About Studies.
16 Years to
ALL
No
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
2030-01