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NCT03346434 · ClinicalTrials.gov registry record · Phase 2
Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)
A Phase 2 study of Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 202
- Enrollment target
- 20
- Study locations
NCT03346434: Completed Phase 2 study of Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals.
NCT03346434 is a Phase 2 study of Dermatitis, Atopic that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 202 participants, below the 390-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03346434, a Phase 2 study of Dermatitis, Atopic, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 202 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).
Primary Outcome
Serum concentration of functional dupilumab was reported.
Conditions Studied
Interventions
- DRUG Matching placebo
- DRUG Dupilumab
Study Locations (20)
California
- Regeneron Investigational Site - Long Beach
- Regeneron Investigational site - Los Angeles
- Regeneron Investigational Site - Palo Alto
- Regeneron Investigational Site - Rolling Hills Estates
- Regeneron Investigational Site - San Diego
Georgia
- Regeneron Investigational Site - Columbus
- Regeneron Investigational Site - Macon
- Regeneron Investigational Site - Sandy Springs
Florida
- Regeneron Investigational Site - Coral Gables
- Regeneron Investigational Site - Tampa
Michigan
- Regeneron Investigational Site - Ann Arbor
- Regeneron Investigational Site - Ypsilanti
Alabama
- Regeneron Investigational Site - Birmingham
Arizona
- Regeneron Investigational Site - Gilbert
District of Columbia
- Regeneron Investigational Site - Washington D.C.
Illinois
- Regeneron Investigational Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2021-07-08 |
| Phase | Phase 2 |
What the finished NCT03346434 record still lists
NCT03346434 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 390-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 2 interventions - of which Matching placebo is the first listed.
NCT03346434 names 20 study sites across 12 states, led by California, Georgia, Florida.
Frequently Asked Questions
What is clinical trial NCT03346434 about?
NCT03346434 is a clinical study titled "Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)". This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).
What is the current status of trial NCT03346434?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 2017-11-30. Estimated completion is 2021-07-08.
What conditions does trial NCT03346434 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT03346434?
The interventions under investigation include: Matching placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT03346434?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03346434 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dermatitis, Atopic
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 NCT03346434's enrollment target sits among peer trials
202 17th of 29 higher than 13 of 29 other Dermatitis, Atopic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatitis, Atopic 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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