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Active, not recruiting Phase 3 Interventional

Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

ClinicalTrials.gov ID: NCT02612454

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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:03 AM EDT

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
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
880 participants

Conditions and interventions

Interventions

Drug

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 14, 2015
Primary completion
Oct 6, 2026
Completion
Oct 6, 2026
Last update posted
May 28, 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 28, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02612454 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →