Long-term assessment of dupilumab for eosinophilic esophagitis in Germany

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Investigational Site Number: 0000009
  Aschaffenburg, Bavaria, Germany Recruiting
• Investigational Site Number: 0000014
  Augsburg, Bavaria, Germany Recruiting
• Investigational Site Number: 0000001
  Dachau, Bavaria, Germany Recruiting
• Investigational Site Number: 0000012
  Erlangen, Bavaria, Germany Recruiting
• Investigational Site Number: 0000005
  Giessen, Hesse, Germany Recruiting
• Investigational Site Number: 0000011
  Wetzlar, Hesse, Germany Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing dupilumab and topical corticosteroids for treating eosinophilic esophagitis

  This study is testing whether a new weekly injection called dupilumab works better than a daily swallowed medication for treating eosinophilic esophagitis in young people aged 12 to 25.

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• Dupilumab for Major Depressive Disorder

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• See if IBI3027 works as well as Dupilumab for moderate to severe atopic dermatitis

  This study tests whether IBI3027 can help people with moderate to severe atopic dermatitis as effectively as Dupilumab injections.

  Recruiting Phase 3 Innovent Biologics (Suzhou) Co. Ltd. · Guangzhou, Guangdong · NCT07754786

• Dupilumab in COPD: Real-world Registry of Outcomes

  This registry tests how dupilumab works for COPD patients in everyday care and whether it lowers flare-ups and improves lung function and quality of life.

  Recruiting at 7 sites Sanofi · Indianapolis, Indiana and 6 other locations · NCT07612878

• Upadacitinib for Eosinophilic Esophagitis in adults not responding to standard therapy

  This study tests whether upadacitinib, taken with topical corticosteroids, can reduce disease activity in adults with eosinophilic esophagitis who still have symptoms.

  Recruiting Phase 2 University of North Carolina, Chapel Hill · Chapel Hill, North Carolina and 1 other locations · NCT07588568

• Dupilumab added to standard COPD care after a flare-up

  This study tests whether adding dupilumab to usual COPD care after a severe flare requiring hospitalization can reduce the chance of another flare.

  Recruiting Phase 4 Regeneron Pharmaceuticals · Mullica Hill, New Jersey · NCT07587658

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.