Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04394351 · ClinicalTrials.gov registry record · Phase 3
Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
A Phase 3 study of Eosinophilic Esophagitis (EoE), sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
- 20
- Study locations
NCT04394351 is a Phase 3 study of Eosinophilic Esophagitis (EoE) that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 102 participants, below the 116-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT04394351, a Phase 3 study of Eosinophilic Esophagitis (EoE), has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
- 20
- Study locations
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2024-05-14 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (12% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
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.
NCT04394351 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Massachusetts, New York, California.
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).
What interventions are being tested in trial NCT04394351?
The interventions under investigation include: Dupilumab (DRUG), Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT04394351?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Eosinophilic Esophagitis (EoE)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
RECRUITING · Phase 3
-
An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)
COMPLETED · Phase 3
-
Surface EMG Testing on Swallowing in EoE Patients
RECRUITING
-
A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
RECRUITING
-
Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)
RECRUITING · Phase 4
-
Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.