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)

Last updated: April 2, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

4

Condition

Heartburn (Pediatric)

Esophageal Disorders

Heartburn

Treatment

Placebo

Dupilumab

Clinical Study ID

NCT06101095
LPS17558
2022-502491-23
U1111-1280-5266
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A documented diagnosis of EoE by endoscopic biopsy.

  • Baseline endoscopic biopsies with a demonstration on central reading ofintraepithelial 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.

Exclusion

Exclusion Criteria:

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 (ChurgStrauss syndrome).

  • Active Helicobacter pylori infection.

  • History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prioresophageal surgery.

  • Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mmupper endoscope or any critical esophageal stricture that requires dilation atscreening.

  • 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 apreviously eliminated food group in the 6 weeks prior to screening.

  • Participation in prior dupilumab clinical study or participants currently treated orhave been treated with commercially available dupilumab or contraindicated todupilumab per local labelling.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
November 29, 2023
Estimated Completion Date:
December 02, 2027

Study Description

The duration per participant will be up to 152 weeks.

Connect with a study center

  • Itaigara Memorial - Hospital Dia- Site Number : 0760005

    Salvador, Bahia 41825-010
    Brazil

    Active - Recruiting

  • Itaigara Memorial Hospital Dia- Site Number : 0760005

    Salvador, Bahia 41825-010
    Brazil

    Active - Recruiting

  • Hospital Sao Lucas da PUCRS Site Number : 0760006

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Active - Recruiting

  • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760006

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Active - Recruiting

  • Clínica Loema - Unidade I- Site Number : 0760007

    Campinas, São Paulo 13010-001
    Brazil

    Active - Recruiting

  • I9 Pesquisas Clinicas- Site Number : 0760007

    Campinas, São Paulo 13092-133
    Brazil

    Active - Recruiting

  • Clinica de Alergia Martti Antila- Site Number : 0760001

    Sorocaba, São Paulo 18040-425
    Brazil

    Active - Recruiting

  • Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760003

    São Paulo, 01323-020
    Brazil

    Active - Recruiting

  • Investigational Site Number : 1240004

    Vancouver, British Columbia V6Z 2K5
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240006

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240002

    Montreal, Quebec H4A 3T2
    Canada

    Active - Recruiting

  • Investigational Site Number : 3760002

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760006

    Haifa, 3104802
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760004

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760005

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760003

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Investigational Site Number : 7560001

    Wetzikon, 8620
    Switzerland

    Active - Recruiting

  • Investigational Site Number : 7560002

    Zürich, 8091
    Switzerland

    Active - Recruiting

  • United Clinical Research Site Number : 8400001

    Murrieta, California 92563
    United States

    Active - Recruiting

  • United Gastroenterologists - Murrieta- Site Number : 8400001

    Murrieta, California 92563
    United States

    Active - Recruiting

  • University of California San Francisco - Parnassus Heights- Site Number : 8400020

    San Francisco, California 94143
    United States

    Active - Recruiting

  • University of California San Francisco Site Number : 8400020

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Borland Groover Clinic- Site Number : 8400016

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • ENCORE Borland Groover Clinical Research Group Site Number : 8400016

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Treasure Valley Medical Research Site Number : 8400018

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Treasure Valley Medical Research- Site Number : 8400018

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Northwestern University Feinberg School of Medicine- Site Number : 8400003

    Chicago, Illinois 60611-2987
    United States

    Active - Recruiting

  • Northwestern University- Site Number : 8400003

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • GI Alliance - Glenview Site Number : 8400012

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • GI Alliance - Glenview- Site Number : 8400012

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • GI Alliance - Gurnee Site Number : 8400004

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • Illinois Gastroenterology Group- Site Number : 8400004

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • University of Iowa Hospitals And Clinics Site Number : 8400006

    Iowa City, Iowa 52242-1009
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics Site Number : 8400006

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa- Site Number : 8400006

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Massachusetts Chan Medical School- Site Number : 8400019

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • University of Massachusetts Memorial Medical Center Site Number : 8400019

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • Mayo Clinic Hospital Rochester- Site Number : 8400008

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Site Number : 8400008

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • University of North Carolina School of Medicine Site Number : 8400007

    Chapel Hill, North Carolina 27516
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill- Site Number : 8400007

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Cleveland Clinic - Cleveland- Site Number : 8400009

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Penn Medicine: University of Pennsylvania Health System- Site Number : 8400010

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pennsylvania Site Number : 8400010

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400015

    Houston, Texas 77074-2085
    United States

    Active - Recruiting

  • Clinical Trial Network - 7080 Southwest Fwy- Site Number : 8400015

    Houston, Texas 77074-2085
    United States

    Active - Recruiting

  • Private Practice - Dr. Martin Yudovich- Site Number : 8400015

    Houston, Texas 77087
    United States

    Site Not Available

  • GI Alliance - Mansfield- Site Number : 8400017

    Mansfield, Texas 76063
    United States

    Site Not Available

  • GI Alliance Research Site Number : 8400017

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • GI Alliance Research- Site Number : 8400017

    Mansfield, Texas 76063
    United States

    Active - Recruiting

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