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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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 880 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 604-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (46% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
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