Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
Completed · Phase 3 · NCT04394351
Conditions: Eosinophilic Esophagitis (EoE)
At a glance
- Research payments reported, 2025
- $423,580
- U.S. investigators named
- 15
- Sites paid
- 14
- Planned or actual enrollment
- 102
About the trial
- Sponsor
- Regeneron Pharmaceuticals (with Sanofi)
- Tested
- Dupilumab (drug), Matching Placebo (drug)
- Dates
- Started 2020-09-01; completion 2024-05-14
- Results posted
- Yes
The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: * To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) * To evaluate the safety, tolerability, and immunogenicity of dupilumab treat…
From ClinicalTrials.gov, last updated 2025-10-27. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Regeneron Pharmaceuticals, Inc. reported $423,580 in research payments for this study in 2025 (113 payments).
Products named: Dupixent
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Melinda J. Braskett, M.D. Allergy & Immunology · Los Angeles, CA
- Vinay Mehta, M.D. Allergy & Immunology · Laguna Niguel, CA
- Yvette K. Wild, M.D., M.P.H. Pediatrics · San Francisco, CA
- Calies D. Menard-katcher, M.D. Pediatrics · Aurora, CO
- Carla Davis, MD Pediatrics · Washington, DC
- Panida Sriaroon, M.D. Pediatrics · Saint Petersburg, FL
- Barbara O. Mcelhanon, MD Pediatrics · Atlanta, GA
- Benjamin P. Davis, M.D. Allergy & Immunology · Iowa City, IA
- Elizabeth A. Lippner, M.D. Allergy & Immunology · Chicago, IL
- John J. Lee, M.D. Allergy & Immunology · Boston, MA
- Ryan T. Pitman, M.D. Pediatric Gastroenterology · Saint Louis, MO
- Evan S. Dellon, M.D., M.P.H. Gastroenterology · Chapel Hill, NC
- Robert J. Szalewski, M.D. Allergy & Immunology · Lincoln, NE
- Jonathan M. Spergel, M.D. Pediatrics · Philadelphia, PA
- Christopher P. Parrish, MD Pediatrics · Dallas, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Baylor College of Medicine $99,220
- Children's Hosp of Los Angeles, CA $50,985
- Childrens Healthcare of Atlanta Inc $35,180
- $31,837
- Boston Children's Hospital, MA $31,577
- The University of North Carolina at Chapel Hill $29,183
- University of Texas Southwestern Medical Center $27,172
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $27,117
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $27,035
- Children's Hospital Colorado, CO $15,657
- University of South Florida $15,429
- Gsr Enterprises Inc $13,977
- University of Iowa Hospital & Clinics, IA $7,709
- Indiana University $5,804
- Children's Hospital of Philadelphia, PA $5,698
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.