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)

Description

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).

Conditions

Eosinophilic Oesophagitis

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Study Overview

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Study Details

Study overview

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).

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)

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)

Condition
Eosinophilic Oesophagitis
Intervention / Treatment

-

Contacts and Locations

Murrieta

United Gastroenterologists - Murrieta- Site Number : 8400001, Murrieta, California, United States, 92563

San Francisco

University of California San Francisco - Parnassus Heights- Site Number : 8400020, San Francisco, California, United States, 94143

Jacksonville

Borland Groover Clinic- Site Number : 8400016, Jacksonville, Florida, United States, 32256

Boise

Treasure Valley Medical Research- Site Number : 8400018, Boise, Idaho, United States, 83706

Glenview

GI Alliance - Glenview- Site Number : 8400012, Glenview, Illinois, United States, 60026

Gurnee

Illinois Gastroenterology Group- Site Number : 8400004, Gurnee, Illinois, United States, 60031

Iowa City

University of Iowa- Site Number : 8400006, Iowa City, Iowa, United States, 52242

Worcester

University of Massachusetts Chan Medical School- Site Number : 8400019, Worcester, Massachusetts, United States, 01655

Rochester

Mayo Clinic Hospital Rochester- Site Number : 8400008, Rochester, Minnesota, United States, 55905

Chapel Hill

University of North Carolina at Chapel Hill- Site Number : 8400007, Chapel Hill, North Carolina, United States, 27514

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

2027-12-02