Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis

This is an open-label, monocentric exploratory phase IIa pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (EoE).

Inclusion Criteria:

• Signed informed consent
• Male or female patients, 18 to 75 years of age
• Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
• Negative pregnancy test in females of childbearing potential

Exclusion Criteria:

• Other causes for esophageal eosinophilia
• Clinical and endoscopic signs of gastroesophageal reflux disease (GERD)
• Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection [candida esophagitis])
• Any known or suspicion for relevant infectious diseases associated with clinical signs,
• Known intolerance/hypersensitivity/resistance to the IMP or excipients or drugs of similar chemical structure or pharmacological profile
• Existing or intended pregnancy or breast-feeding