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COMPLETED Phase 3

Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

NCT04394351 · View on ClinicalTrials.gov ↗

Study Summary

The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: * To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) * To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE * To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation * To study the effects of dupilumab on the type 2 inflammation gene expression signature * To evaluate the concentration-time profile of functional dupilumab in serum in this population * To assess efficacy of long-term (up to 160 weeks) dupilumab treatment * To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study * To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment * To evaluate the impact of dupilumab treatment on EoE signs and symptoms

Interventions

  • DRUG Dupilumab
  • DRUG Matching Placebo

Study Locations (20)

Massachusetts

  • Regeneron Study Site — Boston
  • Regeneron Study Site — Boston
  • Regeneron Study Site — Boston

New York

  • Regeneron Study Site — New York
  • Regeneron Study Site — New York
  • Regeneron Study Site — New York

California

  • Regeneron Study Site — Los Angeles
  • Regeneron Study Site — San Francisco

Georgia

  • Regeneron Study Site — Atlanta
  • Regeneron Study Site — Atlanta

Arizona

  • Regeneron Study Site — Phoenix

Arkansas

  • Regeneron Study Site — Little Rock

Colorado

  • Regeneron Study Site — Aurora

Florida

  • Regeneron Study Site — St. Petersburg

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2020-09-01
Est. Completion 2024-05-14
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04394351

The ClinicalTrials.gov registry entry for NCT04394351 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Eosinophilic Esophagitis (EoE) appearing as the primary indexed condition, and to 2 interventions — of which Dupilumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04394351 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Massachusetts, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04394351 about?

NCT04394351 is a clinical study titled "Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)". The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: * To demonstrate the efficacy of d...

What is the current status of trial NCT04394351?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2020-09-01. Estimated completion is 2024-05-14.

What conditions does trial NCT04394351 study?

This clinical trial studies the following conditions: Eosinophilic Esophagitis (EoE). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04394351?

The interventions under investigation include: Dupilumab (DRUG), Matching Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04394351?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04394351 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial