A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Recruiting
Phase 3
Interventional Study
Eosinophilic Esophagitis (EoE)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 Months – 6
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Regeneron Pharmaceuticals · Industry
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About This Trial
This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.
The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.
The study is look…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
1. Pediatric patients aged ≥6 months and weighing ≥5 kg and \<15 kg at screening with active EoE
2. History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol
3. Baseline endoscopic biopsies, perfo…
Contacts