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

Study acronym: EoE-TOTs
StatusRecruiting
PhasePhase 3
Started2025-11-10
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
minor
Study Status, Contacts/Locations v12
Study sites12→13
2026-08-04
minor
Study Status, Contacts/Locations v11
Study sites11→12
2026-07-01
minor
Study Identification, Study Status v10
Re-verified, no change to tracked fields
2026-06-17
minor
Study Status, Contacts/Locations v9
Study sites10→11
2026-05-18
minor
Study Status, Contacts/Locations v8
Study sites8→10
Show 7 earlier versions
2026-04-07
minor
Study Status, Contacts/Locations v7
Study sites6→8
2026-03-03
minor
Study Status, Contacts/Locations v6
Primary completion date2028-08-21→2028-06-19
Completion date2028-12-11→2028-10-09
Start dateestimated 2026-01-13→confirmed 2025-11-10
Study sites5→6
2026-02-02
minor
Study Status, Contacts/Locations v5
Study sites4→5
2026-01-21
minor
Study Status, Contacts/Locations v4
Study sites3→4
2025-12-01
minor
Study Status, Contacts/Locations v3
Study sites1→3
2025-10-09
minor
Study Status v2
Re-verified, no change to tracked fields
2025-09-03
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2025-08-01
minor
Original filing
148 trials monitored
See 16 trials at risk
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)
Trial Details
NCT Number NCT07112378
Lead Sponsor Regeneron Pharmaceuticals
Collaborators: Sanofi
Conditions Eosinophilic Esophagitis (EoE)
Enrollment 20 participants
Start Date 2025-11-10
Primary Completion 2028-06-19 (estimated)
Study Completion 2028-10-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-29