Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)
Public ClinicalTrials.gov record NCT02612454. 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
An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD. The secondary objectives of the study are: * To assess the long-term efficacy of dupilumab in pediatric participants with AD * To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to \<12 years of age with AD Co-Primary Objectives are: * To evaluate the pharmacokinetic (PK) of dupilumab PFPs * To evaluate the safety of dupilumab PFPs Secondary Objective is: \- To evaluate the immunogenicity of dupilumab PFPs
Study identification
- NCT ID
- NCT02612454
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 880 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 17 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
- Oct 15, 2015 (Actual)
- Primary completion
- Oct 7, 2026 (Estimated)
- Completion
- Oct 7, 2026 (Estimated)
- Last update posted
- May 29, 2026
2015 – 2026
United States locations
- U.S. sites
- 40
- U.S. states
- 22
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Investigational Site | Birmingham | Alabama | 35209 | — |
| Regeneron Investigational Site | Gilbert | Arizona | 85234 | — |
| Regeneron Investigational Site | Bakersfield | California | 93309 | — |
| Regeneron Investigational Site | Long Beach | California | 90808 | — |
| Regeneron Investigational Site | Los Angeles | California | 90027 | — |
| Regeneron Investigational site | Mission Viejo | California | 92691 | — |
| Regeneron Investigational Site | Orange | California | 92868 | — |
| Regeneron Investigational Site | Palo Alto | California | 92304 | — |
| Regeneron Investigational Site | Rolling Hills Estates | California | 90274 | — |
| Regeneron Investigational Site | San Diego | California | 92123 | — |
| Regeneron Investigational Site | Centennial | Colorado | 80112 | — |
| Regeneron Investigational Site | Washington D.C. | District of Columbia | 20016 | — |
| Regeneron Investigational Site | Coral Gables | Florida | 33146 | — |
| Regeneron Investigational Site | Tampa | Florida | 33613 | — |
| Regeneron Investigational Site | Tampa | Florida | 33624 | — |
| Regeneron Investigational Site | Columbus | Georgia | 31904 | — |
| Regeneron Investigational Site | Macon | Georgia | 31217 | — |
| Regeneron Investigational Site | Sandy Springs | Georgia | 30328 | — |
| Regeneron Investigational Site | Chicago | Illinois | 60611 | — |
| Regeneron Investigational Site | Skokie | Illinois | 60077 | — |
| Regeneron Investigational site | Plainfield | Indiana | 46168 | — |
| Regeneron Investigational Site | Rockville | Maryland | 20850 | — |
| Regeneron Investigational Site | Boston | Massachusetts | 02115 | — |
| Regeneron Investigational Site | Boston | Massachusetts | 02116 | — |
| Regeneron Investigational Site | Ypsilanti | Michigan | 48197 | — |
| Regeneron Investigational Site | Plymouth | Minnesota | 55441 | — |
| Regeneron Investigational Site | St Louis | Missouri | 63104 | — |
| Regeneron Investigational Site | Forest Hills | New York | 11375 | — |
| Regeneron Investigational Site | New York | New York | 10029 | — |
| Regeneron Investigational Site | Rochester | New York | 14642 | — |
| Regeneron Investigational Site | Gahanna | Ohio | 43230 | — |
| Regeneron Investigational Site | Portland | Oregon | 97239 | — |
| Regeneron Investigational site | Philadelphia | Pennsylvania | 19104 | — |
| Regeneron Investigational Site | Charleston | South Carolina | 29425 | — |
| Regeneron Investigational Site | North Charleston | South Carolina | 29420 | — |
| Regeneron Investigational Site | Bellaire | Texas | 77401-3505 | — |
| Regeneron Investigational Site | Fort Worth | Texas | 76244 | — |
| Regeneron Investigational Site | San Antonio | Texas | 78218 | — |
| Regeneron Investigational Site | Norfolk | Virginia | 23502 | — |
| Regeneron Investigational 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 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02612454, 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 May 29, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02612454 live on ClinicalTrials.gov.