A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany

Launched by SANOFI · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects and safety of a medication called dupilumab for people aged 12 and older who have a condition known as eosinophilic esophagitis (EoE). EoE is a chronic condition that causes inflammation in the esophagus, often leading to difficulty swallowing and other digestive issues. The trial aims to understand how well dupilumab works in real-life situations, how it impacts patients' quality of life, and gather information about how it is used over time.

To participate, patients must have been diagnosed with EoE and have not found relief from other treatments. They should weigh at least 40 kg and must be starting dupilumab treatment based on their doctor’s recommendation. Participants will be monitored over a two-year period, during which they will provide feedback about their health and any side effects they may experience. It’s important to note that patients who have already been treated with dupilumab for more than a week or have certain health conditions may not be eligible for the study. This trial is currently recruiting participants in Germany, and those who join will be contributing valuable information to help improve the understanding of EoE treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy
• • Patients for whom the treating physician has decided to initiate new treatment with dupilumab for EoE according to EU-SmPC independently from entry in study or for whom treatment with dupilumab for EoE according to EU-SmPC has been started within the last 7 days. The decision to initiate dupilumab treatment is made by the treating physician and the patient according to the patient´s medical need and to the standard of best medical practice. This decision is made independently and before inclusion in this NIS.
• • ≥ 12 years of age at baseline visit
• • ≥ 40 kg bodyweight
• • Voluntary study participation and signed written informed consent by patient and parent(s)/guardian(s), if applicable
• Exclusion Criteria:
• • Patients who have a contraindication to dupilumab according to the current EU-SmPC.
• • Patients who have been treated with dupilumab for more than 7 days
• • Any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
• • Participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study (parallel inclusion in another Sanofi-independent registry might be possible if the patient gives consent)