🏛️ Verified NIH Record • Updated 2026-05-26

Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD) (NCT02612454)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Regeneron Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Regeneron Investigational Site — Birmingham, Alabama

Age range: 6 Months to 17 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (84 Sites)

Showing the first 25 of 84 sites.

  • 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

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗