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NCT Number: NCT06101095

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)

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Eosinophilic Oesophagitis Digestive System Diseases Eosinophilia Eosinophilic Esophagitis Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Itaigara Memorial - Hospital Dia- Site Number : 0760005, Salvador, Estado de Bahia, Brazil

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About this study

The duration per participant will be up to 152 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.

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 (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

Treatment and study plan

Dupilumab

Drug

Subcutaneous injection (SC) as per protocol

Placebo

Drug

SC injection as per protocol

Primary outcomes

  1. Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP)

    Time frame: From baseline to Week 24

    Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.

Secondary outcomes

  1. Percent change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe

    Time frame: From baseline up to Week 24

    Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.

  2. Absolute change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe

    Time frame: From baseline up to Week128

    Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.

  3. Percent change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe

    Time frame: From Baseline up to Week 128

    Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.

  4. Change from baseline in eosinophilic esophagitis-endoscopic reference score (EoE-EREFS)

    Time frame: From baseline up to Week 128

    EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.

  5. Change from baseline in eosinophilic esophagitis (EoE-HSS) Grade

    Time frame: From Baseline up to Week 128

    Severity (grade) and extent (stage) of esophageal abnormalities are scored using a 4-point scale (0 normal; 3 maximum change). Higher score indicates greater severity and extent of histological abnormalities.

  6. Change from baseline in EoE-HSS Stage

    Time frame: From Baseline up to Week 128

    Severity (grade) and extent (stage) of esophageal abnormalities are scored using a 4-point scale (0 normal; 3 maximum change). Higher score indicates greater severity and extent of histological abnormalities.

  7. Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤6 eosinophils/high power field (Eos/HPF)

    Time frame: At Weeks 24, 76 and 128

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

  8. Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤15 Eos/HPF

    Time frame: At Weeks 24, 76 and 128

    Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).

  9. Change from baseline in normalized enrichment score (NES) for EoE diagnostic panel (EDP) transcriptome signature

    Time frame: From baseline up to Week 128 (EOT)

    NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).

  10. Change from baseline in normalized enrichment score (NES) for type 2 inflammation transcriptome signature

    Time frame: From Baseline up to Week 128 (EOT)

    NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).

  11. Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)

    Time frame: From the first IMP administration up to end of post treatment follow up period (week139)

  12. Incidence of adverse events of special interest (AESIs)

    Time frame: From the first IMP administration up to end of post treatment follow up period (week139)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Oct 25, 2023
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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