Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
Public ClinicalTrials.gov record NCT03633617. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT03633617
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 321 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 24, 2018 (Actual)
- Primary completion
- Sep 9, 2021 (Actual)
- Completion
- Jun 7, 2022 (Actual)
- Last update posted
- Jun 28, 2023
2018 – 2022
United States locations
- U.S. sites
- 62
- U.S. states
- 27
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Study Site | Phoenix | Arizona | 85016 | — |
| Regeneron Study Site | Scottsdale | Arizona | 85259 | — |
| Regeneron Study Site | Little Rock | Arkansas | 72202 | — |
| Regeneron Study Site | La Jolla | California | 92037 | — |
| Regeneron Study Site | Los Angeles | California | 90025 | — |
| Regeneron Study Site | Mountain View | California | 94305 | — |
| Regeneron Study Site | Orange | California | 92868 | — |
| Regeneron Study Site | Rolling Hills Estates | California | 90274 | — |
| Regeneron Study Site | San Diego | California | 92123 | — |
| Regeneron Study Site | Aurora | Colorado | 80045 | — |
| Regeneron Study Site | Aurora | Colorado | 80220 | — |
| Regeneron Study Site | Colorado Springs | Colorado | 80907 | — |
| Regeneron Study Site | Lone Tree | Colorado | 80124 | — |
| Regeneron Study Site | Bristol | Connecticut | 06010 | — |
| Regeneron Study Site | Miami | Florida | 33156 | — |
| Regeneron Study Site | St. Petersburg | Florida | 33701 | — |
| Regeneron Study Site | Boise | Idaho | 83706 | — |
| Regeneron Study Site | Idaho Falls | Idaho | 83404 | — |
| Regeneron Study Site #1 | Chicago | Illinois | 60611 | — |
| Regeneron Study Site #2 | Chicago | Illinois | 60611 | — |
| Regeneron Study Site | Park Ridge | Illinois | 60068 | — |
| Regeneron Study Site | Urbana | Illinois | 61801 | — |
| Regeneron Study Site | Indianapolis | Indiana | 46202 | — |
| Regeneron Study Site | Clive | Iowa | 50325 | — |
| Regeneron Study Site | Iowa City | Iowa | 52242 | — |
| Regeneron Study Site | Topeka | Kansas | 66606 | — |
| Regeneron Study Site | Hagerstown | Maryland | 21742 | — |
| Regeneron Study Site | Boston | Massachusetts | 02111 | — |
| Regeneron Study Site | Worcester | Massachusetts | 01655 | — |
| Regeneron Study Site | Ann Arbor | Michigan | 48109 | — |
| Regeneron Study Site | Chesterfield | Michigan | 48047 | — |
| Regeneron Study Site | Plymouth | Minnesota | 55446 | — |
| Regeneron Study Site | Rochester | Minnesota | 55905 | — |
| Regeneron Study Site | Lincoln | Nebraska | 68505 | — |
| Regeneron Study Site | Omaha | Nebraska | 68130 | — |
| Regeneron Study Site | Great Neck | New York | 11021 | — |
| Regeneron Study Site | Great Neck | New York | 11023 | — |
| Regeneron Study Site | New York | New York | 10016 | — |
| Regeneron Study Site | New York | New York | 10029 | — |
| Regeneron Study Site | New York | New York | 10032 | — |
| Regeneron Study Site | The Bronx | New York | 10461 | — |
| Regeneron Study Site | Chapel Hill | North Carolina | 27599 | — |
| Regeneron Study Site | Cincinnati | Ohio | 45229 | — |
| Regeneron Study Site | Dayton | Ohio | 45415 | — |
| Regeneron Study Site | Dublin | Ohio | 43016 | — |
| Regeneron Study Site | Mentor | Ohio | 44060 | — |
| Regeneron Study Site | Hershey | Pennsylvania | 17033 | — |
| Regeneron Study Site | Philadelphia | Pennsylvania | 19104 | — |
| Regeneron Study Site | Charleston | South Carolina | 29425 | — |
| Regeneron Study Site | Greenville | South Carolina | 29615 | — |
| Regeneron Study Site | Johnson City | Tennessee | 37604 | — |
| Regeneron Study Site | Memphis | Tennessee | 38103 | — |
| Regeneron Study Site | Dallas | Texas | 75207 | — |
| Regeneron Study Site | Fort Worth | Texas | 76104 | — |
| Regeneron Study Site | Garland | Texas | 75044 | — |
| Regeneron Study Site | Houston | Texas | 77030 | — |
| Regeneron Study Site | San Antonio | Texas | 78229 | — |
| Regeneron Study Site | Salt Lake City | Utah | 84132 | — |
| Regeneron Study Site | Charlottesville | Virginia | 22903 | — |
| Regeneron Study Site | Roanoke | Virginia | 24013 | — |
| Regeneron Study Site | Seattle | Washington | 98115 | — |
| Regeneron Study Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03633617, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 28, 2023 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03633617 live on ClinicalTrials.gov.