Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Conditions Studied

Eosinophilic Esophagitis

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

FieldValue
Enrollment Target 321 participants
Start Date 2018-09-24
Est. Completion 2022-06-07
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

280 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03633617

The ClinicalTrials.gov registry entry for NCT03633617 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 321 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 857-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (63% 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 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03633617 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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

Similar trials for Eosinophilic Esophagitis

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.

Explore more on PlainTrial

Eosinophilic Esophagitis

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.