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A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)
Sponsor: Sanofi
Summary
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis. Duration of study period (per participant) * Screening period: Up to 12 weeks before Week 0 * Randomized double-blind period: 24 weeks * Open label period: 104 weeks * Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first. There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).
Official title: A Phase 4, Randomized, Multicenter, Double-blind, Parallel-group, 24 Weeks, Placebo-controlled Study Followed by 104 Weeks Open-label to Assess Dupilumab Efficacy on Esophageal Function and Remodeling in Adult Participants With Eosinophilic Esophagitis (EoE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2023-11-29
Completion Date
2028-02-01
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
Dupilumab
Subcutaneous injection (SC) as per protocol
Placebo
SC injection as per protocol
Locations (30)
United Gastroenterologists - Murrieta- Site Number : 8400001
Murrieta, California, United States
University of California San Francisco - Parnassus Heights- Site Number : 8400020
San Francisco, California, United States
Borland Groover Clinic- Site Number : 8400016
Jacksonville, Florida, United States
Treasure Valley Medical Research- Site Number : 8400018
Boise, Idaho, United States
Northwestern University- Site Number : 8400003
Chicago, Illinois, United States
GI Alliance - Glenview- Site Number : 8400012
Glenview, Illinois, United States
Illinois Gastroenterology Group- Site Number : 8400004
Gurnee, Illinois, United States
University of Iowa- Site Number : 8400006
Iowa City, Iowa, United States
University of Massachusetts Chan Medical School- Site Number : 8400019
Worcester, Massachusetts, United States
Mayo Clinic Hospital Rochester- Site Number : 8400008
Rochester, Minnesota, United States
University of North Carolina at Chapel Hill- Site Number : 8400007
Chapel Hill, North Carolina, United States
Cleveland Clinic - Cleveland- Site Number : 8400009
Cleveland, Ohio, United States
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400010
Philadelphia, Pennsylvania, United States
Private Practice - Dr. Martin Yudovich- Site Number : 8400015
Houston, Texas, United States
GI Alliance - Mansfield- Site Number : 8400017
Mansfield, Texas, United States
Itaigara Memorial - Hospital Dia- Site Number : 0760005
Salvador, Estado de Bahia, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006
Porto Alegre, Rio Grande do Sul, Brazil
Clínica Loema - Unidade I- Site Number : 0760007
Campinas, São Paulo, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760001
Sorocaba, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760003
São Paulo, Brazil
Investigational Site Number : 1240006
Vancouver, British Columbia, Canada
Investigational Site Number : 1240004
Vancouver, British Columbia, Canada
Investigational Site Number : 1240002
Montreal, Quebec, Canada
Investigational Site Number : 3760006
Haifa, Israel
Investigational Site Number : 3760002
Haifa, Israel
Investigational Site Number : 3760005
Jerusalem, Israel
Investigational Site Number : 3760004
Jerusalem, Israel
Investigational Site Number : 3760003
Tel Aviv, Israel
Investigational Site Number : 7560001
Wetzikon, Switzerland
Investigational Site Number : 7560002
Zurich, Switzerland