Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

This is an interventional treatment trial for Eosinophilic Esophagitis Read More

Inclusion Criteria:

• male and female subjects aged 18 to 65 years with a diagnosis of eosinophilic esophagitis for at least 3 months;
• active eosinophilic esophagitis with ≥ 15 eosinophils/HPF in at least 2 of 3 biopsied levels of the esophagus (distal, mid, or proximal), SDI PRO ≥ 5 and 2 or more episodes of dysphagia per week on average; willing to adhere to a stable diet throughout the study.

Exclusion Criteria:

• any active or history of gastrointestinal conditions aside from eosinophilic esophagitis including Crohn's disease, ulcerative colitis, celiac disease or achalasia;
• gross endoscopic abnormalities in the stomach or duodenum at baseline or found on biopsy specimens;
• impending or history of need for esophageal surgery;
• esophageal strictures incapable of being passed by endoscope without dilation;
• use of biologics, corticosteroids, or immunosuppressants within 4 weeks or 5 half-lives prior to baseline, whichever is longer;
• recent bacterial, fungal or viral infection prior to screening or baseline;
• presence or history of any medical condition, including cancer, that may influence the results of the study