ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
Study Purpose
This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 70 Years |
Gender | All |
Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03093259 |
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Abivax S.A. |
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Paul GINESTE |
Principal Investigator Affiliation | Abivax S.A. |
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Belgium |
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ulcerative Colitis |
Contact a Trial Team
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