Dupilumab for young children with eosinophilic esophagitis (food-pipe inflammation)
A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis
This study will test whether 24 weeks of dupilumab helps infants and toddlers with active eosinophilic esophagitis improve feeding and reduce esophageal inflammation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Months to 6 Years |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | dupilumab |
| Locations | 8 sites (Phoenix, Arizona and 7 other locations) |
| Trial ID | NCT07112378 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional trial gives dupilumab to children aged 6 months who weigh between 5 and <15 kg and have active eosinophilic esophagitis confirmed by endoscopic biopsies. Treatment is administered over 24 weeks with regular clinic visits to monitor symptoms and side effects and to collect blood for drug levels and antibody testing. Baseline endoscopies are centrally read and must show intraepithelial eosinophil infiltration in at least two of three esophageal regions. The protocol excludes prior dupilumab exposure, other causes of esophageal eosinophilia, and recent changes to food-elimination diets.
Who should consider this trial
Good fit: Children aged ≥6 months who weigh 5–<15 kg, have active EoE with recent symptoms and central-read biopsies showing eosinophils in at least two of three esophageal regions, and have not previously received dupilumab.
Not a fit: Children with other causes of esophageal eosinophilia (such as eosinophilic gastroenteritis or hypereosinophilic syndrome), prior dupilumab treatment, or recent changes to a food-elimination diet are unlikely to be eligible or to benefit from this study.
Why it matters
Potential benefit: If successful, dupilumab could reduce esophageal inflammation and improve feeding, nourishment, and symptoms in very young children with EoE.
How similar studies have performed: Dupilumab has shown benefit for eosinophilic esophagitis in older children and adults, but evidence in very young children is limited.
Eligibility criteria
Show full inclusion / exclusion 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, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol Key Exclusion Criteria: 1. Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab 2. Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study 3. Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) 4. Active Helicobacter pylori infection 5. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery 6. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening 7. History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopic procedure 8. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Where this trial is running
Phoenix, Arizona and 7 other locations
- Phoenix Childrens Hospital — Phoenix, Arizona, United States (Recruiting)
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- GI Care for Kids LLC — Atlanta, Georgia, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- University of North Carolina, Bioinformatics Building — Chapel Hill, North Carolina, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Cook Children's Medical Center — Fort Worth, Texas, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
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.