Actively Recruiting
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Led by Regeneron Pharmaceuticals · Updated on 2026-04-08
20
Participants Needed
8
Research Sites
152 weeks
Total Duration
On this page
Sponsors
R
Regeneron Pharmaceuticals
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
CONDITIONS
Official Title
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged 6 months to less than 6 years weighing between 5 kg and less than 15 kg at screening with active eosinophilic esophagitis (EoE)
- History of symptoms caused by EoE within the month before screening as determined by the investigator
- Baseline endoscopic biopsies during screening showing eosinophilic infiltration in at least two of three esophageal regions on central reading
You will not qualify if you...
- Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab
- Starting or changing a food-elimination diet or reintroducing eliminated foods within 6 weeks before screening; must remain on the same diet during the study
- Other causes of esophageal eosinophilia or conditions like eosinophilic gastroenteritis, hypereosinophilic syndrome, or eosinophilic granulomatosis with polyangiitis
- Active Helicobacter pylori infection
- History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
- Esophageal strictures that cannot be passed with a standard upper endoscope or require dilation at screening
- History of bleeding disorders or esophageal varices posing high risk for complications from endoscopy
- Treatment with swallowed topical corticosteroids within 8 weeks before baseline endoscopy
- Other protocol-defined inclusion and exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
GI Care for Kids LLC
Atlanta, Georgia, United States, 30342
Actively Recruiting
4
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
5
University of North Carolina, Bioinformatics Building
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
7
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
8
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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