Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
Public ClinicalTrials.gov record NCT03345914. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly With Topical Corticosteroids in Patients, ≥6 Years to <12 Years of Age, With Severe Atopic Dermatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to \<12 years of age with severe atopic dermatitis (AD). The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to \<12 years of age with severe AD.
Study identification
- NCT ID
- NCT03345914
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 367 participants
Conditions and interventions
Conditions
Interventions
- Dupilumab Drug
- Matching Placebo Drug
- Background Treatment: Topical Corticosteroids Other
- Background Treatment: Moisturizers Other
Drug · Other
Eligibility (public fields only)
- Age range
- 6 Years to 11 Years
- 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
- Nov 17, 2017 (Actual)
- Primary completion
- Jun 20, 2019 (Actual)
- Completion
- Sep 10, 2019 (Actual)
- Last update posted
- Aug 13, 2020
2017 – 2019
United States locations
- U.S. sites
- 31
- U.S. states
- 19
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Research Site | Birmingham | Alabama | 35209 | — |
| Regeneron Research Site | Gilbert | Arizona | 85234 | — |
| Regeneron Research Site | Bakersfield | California | 93309 | — |
| Regeneron Research Site | Long Beach | California | 90808 | — |
| Regeneron Research Site | Mission Viejo | California | 92691 | — |
| Regeneron Research Site | Rolling Hills Estates | California | 90274 | — |
| Regeneron Research Site | San Diego | California | 92123 | — |
| Regeneron Research Site | Denver | Colorado | 80206 | — |
| Regeneron Research Site | Coral Gables | Florida | 33146 | — |
| Regeneron Research Site | Tampa | Florida | 33612 | — |
| Regeneron Research Site | Tampa | Florida | 33624 | — |
| Regeneron Research Site | Macon | Georgia | 31217 | — |
| Regeneron Research Site | Sandy Springs | Georgia | 30328 | — |
| Regeneron Research Site | Chicago | Illinois | 60611 | — |
| Regeneron Research Site | Normal | Illinois | 61761 | — |
| Regeneron Research Site | Rockville | Maryland | 20850 | — |
| Regeneron Research Site | Ypsilanti | Michigan | 48197 | — |
| Regeneron Research Site | Minneapolis | Minnesota | 55402 | — |
| Regeneron Research Site | St Louis | Missouri | 63104 | — |
| Regeneron Research Site | Forest Hills | New York | 11375 | — |
| Regeneron Research Site | New York | New York | 10029 | — |
| Regeneron Research Site | Rochester | New York | 14620 | — |
| Regeneron Research Site | Gahanna | Ohio | 43230 | — |
| Regeneron Research Site | Portland | Oregon | 97239 | — |
| Regeneron Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Regeneron Research Site | Charleston | South Carolina | 29425 | — |
| Regeneron Research Site | North Charleston | South Carolina | 29420 | — |
| Regeneron Research Site | Bellaire | Texas | 77401 | — |
| Regeneron Research Site | San Antonio | Texas | 78218 | — |
| Regeneron Research Site | Norfolk | Virginia | 23502 | — |
| Regeneron Research Site | Seattle | Washington | 98105 | — |
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 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03345914, 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 Aug 13, 2020 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03345914 live on ClinicalTrials.gov.