A phase 2b, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of obefazimod in subjects with moderately to severely active Crohn's disease
Principal Investigator
Study Number
STUDY02002477
Summary
The main purpose of this study is to see if the study drug is safe and effective in treating your CD, and whether it is safe when given for an extended period of time. This is a Phase 2 study. This means that the study drug has already been tested in small numbers of healthy volunteers. In addition, the study drug has been tested in subjects with other medical conditions, including ulcerative colitis (another inflammatory bowel disease). This study is now testing the study drug in a group of subjects with CD. Obefazimod is the study drug that is being tested in this study. The study drug (obefazimod) is an experimental drug that has not yet been approved by any health authority (government authorities), such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), for treating subjects with CD. Obefazimod is designed to trigger anti-inflammatory actions in the body by increasing the activity of a substance called microRNA-124, or miR-124. Micro-RNA are small forms of RNA (genetic material) that are found in the body’s cells and blood and are involved in many of the cell’s activities. MiR-124 works by blocking certain proteins that are involved in inflammatory reactions in the body.
Phase
II
Contact
Available at the following location(s)
- Lebanon
View more details at ClinicalTrials.gov
Do you need help with some of the labels on this page?
Read our glossary of terms