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COMPLETED Phase 3

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

NCT03633617 · View on ClinicalTrials.gov ↗

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

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

290 total trials

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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. 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 321 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 appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT03633617 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Colorado, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03633617?

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

Who is sponsoring clinical trial NCT03633617?

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 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.

Related

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