Long-term assessment of dupilumab for eosinophilic esophagitis in Germany
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
This study is testing how well dupilumab works and how safe it is for people aged 12 and older with eosinophilic esophagitis in Germany over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | dupilumab |
| Locations | 1 site (Dachau, Bavaria) |
| Trial ID | NCT06695897 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term efficacy and safety of dupilumab in patients aged 12 and older with eosinophilic esophagitis (EoE) under real-world conditions in Germany. It will collect data on patient demographics, medical history, comorbidities, and treatment patterns over a two-year period. The effectiveness of dupilumab will be assessed by both treating physicians and patients, focusing on health-related quality of life. The study will also gather long-term safety data associated with dupilumab treatment.
Who should consider this trial
Good fit: Ideal candidates include patients aged 12 and older with eosinophilic esophagitis who are inadequately controlled by or intolerant to conventional therapies.
Not a fit: Patients who have contraindications to dupilumab or who are not candidates for this treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of dupilumab for patients with eosinophilic esophagitis.
How similar studies have performed: Other studies have shown promising results with dupilumab for similar conditions, indicating a potential for success in this observational approach.
Eligibility criteria
Show full inclusion / exclusion 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 patients' 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 patients' 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) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where this trial is running
Dachau, Bavaria
- Investigational Site Number: 0000001 — Dachau, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.