Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05488405
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dr. Falk Pharma GmbH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Luc Biedermann, PD Dr. med.
Principal Investigator Affiliation	UniversitätsSpital Zürich Klinik für Gastroenterologie und Hepatologie
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Switzerland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Additional Details

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).

Arms & Interventions

Arms

Experimental: Mesalamine treatment

Treatment of patient with mesalamine oral suspension

Interventions

Drug: - Mesalamine Oral Product

Mesalamine oral suspension for oral use

Contact a Trial Team

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International Sites

Universitätsspital Zürich, Zürich, Switzerland

Status

Address

Universitätsspital Zürich

Zürich, , 8091

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