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NCT02612454 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)
A Phase 3 study of Atopic Dermatitis, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 880
- Enrollment target
- 20
- Study locations
NCT02612454: Active Phase 3 study of Atopic Dermatitis, sponsored by Regeneron Pharmaceuticals.
NCT02612454 is a Phase 3 study of Atopic Dermatitis that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 880 participants, above the 604-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02612454, a Phase 3 study of Atopic Dermatitis, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 880 participants
- Enrollment target
- 20
- Study locations
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 |
What the registry record for NCT02612454 still lists
NCT02612454 is an interventional study that assigns participants to a tested intervention. The registered 880 participants enrollment target is mid-sized for trials with a published cap, above the 604-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (46% higher).
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.
NCT02612454 names 20 study sites across 8 states, led by California, Florida, Georgia.
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.
What interventions are being tested in trial NCT02612454?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT02612454?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Atopic Dermatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02612454's enrollment target sits among peer trials
880 17th of 150 higher than 134 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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