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Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)
NCT02612454 · View on ClinicalTrials.gov ↗
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
Conditions Studied
Interventions
- DRUG Dupilumab
Study Locations (20)
California
- Regeneron Investigational Site — Bakersfield
- Regeneron Investigational Site — Long Beach
- Regeneron Investigational Site — Los Angeles
- Regeneron Investigational site — Mission Viejo
- Regeneron Investigational Site — Orange
- Regeneron Investigational Site — Palo Alto
- Regeneron Investigational Site — Rolling Hills Estates
- Regeneron Investigational Site — San Diego
Florida
- Regeneron Investigational Site — Coral Gables
- Regeneron Investigational Site — Tampa
- Regeneron Investigational Site — Tampa
Georgia
- Regeneron Investigational Site — Columbus
- Regeneron Investigational Site — Macon
- Regeneron Investigational Site — Sandy Springs
Illinois
- Regeneron Investigational Site — Chicago
- Regeneron Investigational Site — Skokie
Alabama
- Regeneron Investigational Site — Birmingham
Arizona
- Regeneron Investigational Site — Gilbert
Colorado
- Regeneron Investigational Site — Centennial
District of Columbia
- Regeneron Investigational Site — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 880 participants |
| Start Date | 2015-10-15 |
| Est. Completion | 2026-10-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02612454
The ClinicalTrials.gov registry entry for NCT02612454 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 880 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention — of which Dupilumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02612454 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02612454 about?
NCT02612454 is a clinical study titled "Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)". 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 dupi...
What is the current status of trial NCT02612454?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 880 participants. The study started on 2015-10-15. Estimated completion is 2026-10-07.
What conditions does trial NCT02612454 study?
This clinical trial studies the following conditions: Atopic Dermatitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02612454?
The interventions under investigation include: Dupilumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02612454?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02612454 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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