The study (Res-05-0002) is a randomized, double-blind trial of reslizumab versus placebo in the treatment of pediatric patients between five and 18 years of age with poorly-controlled EE. Subjects will be randomized to one of three active dose groups or placebo, administered at monthly intervals for four months. The co-primary endpoints of the study are changes in clinical symptoms and esophageal eosinophil levels at the end of therapy. The clinical study is being conducted at multiple centers and will enroll approximately 172 patients.
The FDA has granted orphan drug status to reslizumab for the treatment of pediatric EE. Depending upon the study results, Ception expects to file a biological license application with the FDA for reslizumab based on this study.