Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Dr. Falk Pharma

Status and phase: Completed; Phase 2

Conditions: Eosinophilic Esophagitis

Treatments: Drug: Mesalamine Oral Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT05488405

SAV-1/EEA

Details and patient eligibility

About

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

Full description

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).

Enrollment: 5 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Mesalamine treatment

Experimental group

Description:

Treatment of patient with mesalamine oral suspension

Treatment:

Drug: Mesalamine Oral Product