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Purpose

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)

Condition

Eligibility

Eligible Ages
Between 6 Months and 6 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dosing Regimen 1
  • Drug: dupilumab
    Administered as defined in the protocol
    Other names:
    • DUPIXENT®
    • REGN668
    • SAR231893
Experimental
Dosing Regimen 2
  • Drug: dupilumab
    Administered as defined in the protocol
    Other names:
    • DUPIXENT®
    • REGN668
    • SAR231893

Recruiting Locations

Phoenix Childrens Hospital
Phoenix 5308655, Arizona 5551752 85016

GI Care for Kids LLC
Atlanta 4180439, Georgia 4197000 30342

University of Virginia
Charlottesville 4752031, Virginia 6254928 22908

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.