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)

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Eosinophilic Oesophagitis

In brief

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).

Key facts

Study ID

NCT06101095

Run by

Sanofi

People needed

69

Starts

2023-11-29

Expected to finish

2028-02-01

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A documented diagnosis of EoE by endoscopic biopsy.
• Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration.
• History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.
• Body weight ≥40 kg.

You may not qualify if…

• Participants are excluded from the study if any of the following criteria apply:
• Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome).
• Active Helicobacter pylori infection.
• History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery.
• Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening.
• History of bleeding disorders or esophageal varices.
• Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline.
• Initiation or change of a food elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to screening.
• Participation in prior dupilumab clinical study or participants currently treated or have been treated with commercially available dupilumab or contraindicated to dupilumab per local labelling.
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Where it is running

• 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

Full record on ClinicalTrials.gov

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