A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07112378
Phase
PHASE3
Status
Recruiting
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Conditions

  • Eosinophilic Esophagitis (EoE)

Eligibility Criteria

Sex
ALL
Age
6 Months - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • dupilumab — DRUG
    Administered as defined in the protocol

Study Details

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)

Key Dates

Start date
Nov 10, 2025
Status verified
May 2026
Primary completion
Jun 19, 2028
Completion
Oct 9, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dosing Regimen 1
  • Experimental: Dosing Regimen 2

Primary Outcome Measure

Incidence of treatment-emergent Serious Adverse Events (SAEs) [ Time Frame: Up to 24 Weeks ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Phoenix Childrens HospitalPhoenixArizona85016-
Children's Hospital ColoradoAuroraColorado80045-
GI Care for Kids LLCAtlantaGeorgia30342-
Massachusetts General HospitalBostonMassachusetts02114-
Weill Cornell MedicineNew YorkNew York10065-
University of North Carolina, Bioinformatics BuildingChapel HillNorth Carolina27599-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Cook Children's Medical CenterFort WorthTexas76104-
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Phoenix, AZ

By research site
Phoenix Childrens Hospital· Phoenix, AZChildren's Hospital Colorado· Aurora, COGI Care for Kids LLC· Atlanta, GAMassachusetts General Hospital· Boston, MAWeill Cornell Medicine· New York, NYUniversity of North Carolina, Bioinformatics Building· Chapel Hill, NC

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