Prospective, non-interventional observational study for characterization of long term treatment with Dupilumab in eosinophile eosophagitis in clinic routine, in safety and patient reported health characeristics (quality of life)

Prospective, non-interventional observational study for characterization of long term treatment with Dupilumab in eosinophile eosophagitis in clinic routine, in safety and patient reported health characeristics (quality of life) - ProMEAL

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037323

Enrollment

Registered

2025-07-18

Start date

2025-07-14

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

eosinophile eosinophagitis

Interventions

Group 1: Characterization of patients with eosonophile eosophagitis (EoE) in age from 12 years with body weight (KG) of at least 40 kg, which are inadequately treated with conventional drug therapy, d

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients at age of 12 and elder and minimum 40kg body weight with beginning treatment with Dupilumab is planned for treatment of EOE that are inadequately treated with conventional drug therapy, do not tolerate these or who are not considered for such therapy according investigational brochure or those who begun the treatment with Dupilumab in the last 7 days before beginning the non-interventional study, if all necessary baseline data are collected and are taken from the clinical file and have signed the informed consent

Exclusion criteria

Exclusion criteria: treatment with Dupilumab for more than 7 days and not signing the informed consent

Design outcomes

Primary

Measure	Time frame
descreptive statistic analysis of the medical prehistory as well as sociodemografic and disease characteristics	—

Secondary

Measure	Time frame
behavioral changes when eating (as reported by the patient) after 1, 3, 6, 9, 12, 18 and 24 months of Dupilumab treatment opposite baseline Number of hospitalizations and days off work due to the EoE during the last 12 months before beginning of the study (baseline) and 12 and 24 months after the treatment with Dupilumab reasons for beginning with the treatment with Dupilumab descriptive statistic analysis of details of the Dupilumab treatment	—

Measure

Time frame

behavioral changes when eating (as reported by the patient) after 1, 3, 6, 9, 12, 18 and 24 months of Dupilumab treatment opposite baseline Number of hospitalizations and days off work due to the EoE during the last 12 months before beginning of the study (baseline) and 12 and 24 months after the treatment with Dupilumab reasons for beginning with the treatment with Dupilumab descriptive statistic analysis of details of the Dupilumab treatment

—

Countries

Germany

Contacts

Public ContactUlrike von Arnim

Universitätsklinikum Magdeburg

ulrike.vonarnim@med.ovgu.de+ 49 391 67 13 100

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026