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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: Completed Phase 3 study of Eosinophilic Esophagitis (EoE), sponsored by Regeneron Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Peak esophageal intraepithelial eosinophil count was measured from esophageal biopsies. A total of at least 9 mucosal pinch biopsies were collected from 3 esophageal regions: 3 proximal, 3 mid, and 3 distal. The peak esophageal intraepithelial eosinophil count at each visit was the maximum of the quantities of eosinophils in the most inflamed hpfs across the 3 regions. If the quantity of eosinophils was missing for 1 or 2 esophageal regions, the peak eosinophil count was the maximum of the quant
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 |
What the finished NCT04394351 record still lists
NCT04394351 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 116-participant average among 10 other Eosinophilic Esophagitis (EoE) trials with a reported enrollment target (12% lower).
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 names 20 study sites across 14 states, led by 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
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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.
Where NCT04394351's enrollment target sits among peer trials
102 5th of 10 higher than 6 of 10 other Eosinophilic Esophagitis (EoE) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis (EoE) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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