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NCT03633617 · ClinicalTrials.gov registry record · Phase 3
Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
A Phase 3 study of Eosinophilic Esophagitis, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 321
- Enrollment target
- 20
- Study locations
NCT03633617: Completed Phase 3 study of Eosinophilic Esophagitis, sponsored by Regeneron Pharmaceuticals.
NCT03633617 is a Phase 3 study of Eosinophilic Esophagitis that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 321 participants, below the 857-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03633617, a Phase 3 study of Eosinophilic Esophagitis, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 321 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of the study by study part are: Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B. Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures. Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures. The secondary objectives of the study are: * To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE * To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses * To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation * To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids
Primary Outcome
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab
Study Locations (20)
California
- Regeneron Study Site - La Jolla
- Regeneron Study Site - Los Angeles
- Regeneron Study Site - Mountain View
- Regeneron Study Site - Orange
- Regeneron Study Site - Rolling Hills Estates
- Regeneron Study Site - San Diego
Colorado
- Regeneron Study Site - Aurora
- Regeneron Study Site - Aurora
- Regeneron Study Site - Colorado Springs
- Regeneron Study Site - Lone Tree
Arizona
- Regeneron Study Site - Phoenix
- Regeneron Study Site - Scottsdale
Florida
- Regeneron Study Site - Miami
- Regeneron Study Site - St. Petersburg
Idaho
- Regeneron Study Site - Boise
- Regeneron Study Site - Idaho Falls
Illinois
- Regeneron Study Site #1 - Chicago
- Regeneron Study Site #2 - Chicago
Arkansas
- Regeneron Study Site - Little Rock
Connecticut
- Regeneron Study Site - Bristol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2018-09-24 |
| Est. Completion | 2022-06-07 |
| Phase | Phase 3 |
What the finished NCT03633617 record still lists
NCT03633617 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, below the 857-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03633617 names 20 study sites across 8 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT03633617 about?
NCT03633617 is a clinical study titled "Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)". The primary objectives of the study by study part are: Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size de...
What is the current status of trial NCT03633617?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 321 participants. The study started on 2018-09-24. Estimated completion is 2022-06-07.
What conditions does trial NCT03633617 study?
This clinical trial studies the following conditions: Eosinophilic Esophagitis.
What interventions are being tested in trial NCT03633617?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT03633617?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03633617 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03633617's enrollment target sits among peer trials
321 11th of 44 higher than 34 of 44 other Eosinophilic Esophagitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis 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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