Dupilumab for young children with eosinophilic esophagitis (food-pipe inflammation)

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Phoenix Childrens Hospital
  Phoenix, Arizona, United States Recruiting
• University of California San Francisco (UCSF)
  San Francisco, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• GI Care for Kids LLC
  Atlanta, Georgia, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

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

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• Natural history of eosinophilic esophagitis in adults and children

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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.