Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT05488405
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05488405
Study Brief:
Protocol Section:
NCT05488405