Not a traditional drug phase: testing Dupilumab for Eosinophilic Esophagitis
This is a longitudinal, watch-and-measure (no experimental treatment required) non-treatment 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 watch-and-measure (no experimental treatment required) period of two years.
Official registry: https://clinicaltrials.gov/study/NCT06695897 · Sanofi · enrollment listed as 150
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 150 people at 15 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: Dupilumab
Primary outcome (registry wording): Descriptive statistical analysis of medical history characteristics
Who it is for (from inclusion criteria)
- Ages 12 Years to any
- Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy
- ≥ 12 years of age at baseline visit
Who the registry excludes
- 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 treatment or watch-and-measure (no experimental treatment required) 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
Public study contact (from the registry)
Trial Transparency email recommended (Toll free for US & Canada)
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
15 listed- 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)
- Investigational Site Number: 0000013 — Osnabrück, Lower Saxony, Germany (recruiting)
- Investigational Site Number: 0000002 — Weyhe-Kirchweyhe, Lower Saxony, Germany (recruiting)
- Investigational Site Number: 0000007 — Bochum, North Rhine-Westphalia, Germany (recruiting)
- Investigational Site Number: 0000003 — Burbach, North Rhine-Westphalia, Germany (recruiting)
- Investigational Site Number: 0000006 — Guelders, North Rhine-Westphalia, Germany (recruiting)
- Investigational Site Number: 0000010 — Münster, North Rhine-Westphalia, Germany (recruiting)
FAQ about this NCT record
Is NCT06695897 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06695897?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06695897?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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