Summary

Eligibility
for people ages 6 months to 6 years (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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)

Official Title

A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis (EoE), Type 2 Inflammatory, Allergic/immune-mediated, Esophageal dysfunction, Eosinophilic Esophagitis, Esophageal Diseases, dupilumab

Eligibility

You can join if…

Open to people ages 6 months to 6 years

  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

You CAN'T join if...

  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

Locations

  • University of California San Francisco (UCSF) accepting new patients
    San Francisco California 94143 United States
  • Phoenix Childrens Hospital accepting new patients
    Phoenix Arizona 85016 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT07112378
Phase
Phase 3 Eosinophilic Esophagitis Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated