Prospective, Non-interventional Observational Study to Characterize Dupilumab in the Long-term Management of Eosinophilic Esophagitis, Safety and Patient Reported Outcomes (Quality of Life) in Clinical Routine

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with respect to their medical history, socio-demographic and disease characteristics, comorbidities (including type 2 inflammatory and atopic conditions), concomitant therapies and prior EoE treatments. Furthermore, this NIS aims to describe the long-term effectiveness of dupilumab for the treatment of EoE as assessed by the treating physician and reported by the patient, and its effect on health-related quality of life (HRQoL) during an individual observational period of two years. In addition, data on real-world use patterns and long-term safety data of dupilumab treatment for EoE will be collected.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Germany
Investigational Site Number: 0000001
RECRUITING
Dachau
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2029-05-29
Participants
Target number of participants: 150
Treatments
Dupilumab arm
Patients who receive dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Sanofi

This content was sourced from clinicaltrials.gov