Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)
Condition(s) studied
Investigational drug(s) / intervention(s)
Dupilumab: Weight-tiered dosing administered subcutaneous (SC)
Study summary
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
Eligibility
Primary outcome measure(s)
- Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit — Baseline up to week 272
- Number of participants with at least one TEAE per participant year from baseline through the last study visit — Baseline up to week 272
- OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax) — Up to week 16
Peak serum concentration after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference) - OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough) — Up to week 16
Drug concentration in serum after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference) - OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study — Up to week 16
- OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study — Up to week 16
Trial sites (84)
| Facility | City | Region | Status |
|---|---|---|---|
| Regeneron Investigational Site | Birmingham | Alabama | |
| Regeneron Investigational Site | Gilbert | Arizona | |
| Regeneron Investigational Site | Bakersfield | California | |
| Regeneron Investigational Site | Long Beach | California | |
| Regeneron Investigational Site | Los Angeles | California | |
| Regeneron Investigational site | Mission Viejo | California | |
| Regeneron Investigational Site | Orange | California | |
| Regeneron Investigational Site | Palo Alto | California | |
| Regeneron Investigational Site | Rolling Hills Estates | California | |
| Regeneron Investigational Site | San Diego | California | |
| Regeneron Investigational Site | Centennial | Colorado | |
| Regeneron Investigational Site | Washington D.C. | District of Columbia | |
| Regeneron Investigational Site | Coral Gables | Florida | |
| Regeneron Investigational Site | Tampa | Florida | |
| Regeneron Investigational Site | Tampa | Florida | |
| Regeneron Investigational Site | Columbus | Georgia | |
| Regeneron Investigational Site | Macon | Georgia | |
| Regeneron Investigational Site | Sandy Springs | Georgia | |
| Regeneron Investigational Site | Chicago | Illinois | |
| Regeneron Investigational Site | Skokie | Illinois | |
| Regeneron Investigational site | Plainfield | Indiana | |
| Regeneron Investigational Site | Rockville | Maryland | |
| Regeneron Investigational Site | Boston | Massachusetts | |
| Regeneron Investigational Site | Boston | Massachusetts | |
| Regeneron Investigational Site | Ypsilanti | Michigan | |
| Regeneron Investigational Site | Plymouth | Minnesota | |
| Regeneron Investigational Site | St Louis | Missouri | |
| Regeneron Investigational Site | Forest Hills | New York | |
| Regeneron Investigational Site | New York | New York | |
| Regeneron Investigational Site | Rochester | New York | |
| Regeneron Investigational Site | Gahanna | Ohio | |
| Regeneron Investigational Site | Portland | Oregon | |
| Regeneron Investigational site | Philadelphia | Pennsylvania | |
| Regeneron Investigational Site | Charleston | South Carolina | |
| Regeneron Investigational Site | North Charleston | South Carolina | |
| Regeneron Investigational Site | Bellaire | Texas | |
| Regeneron Investigational Site | Fort Worth | Texas | |
| Regeneron Investigational Site | San Antonio | Texas | |
| Regeneron Investigational Site | Norfolk | Virginia | |
| Regeneron Investigational Site | Seattle | Washington |
+ 44 more sites — see the full list on the official registry below.
On this site
📄 Dupixent (dupilumab) drug profile →More Regeneron Pharmaceuticals trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02612454 on ClinicalTrials.gov ↗ ← All trials in Poland