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NCT03345914 · ClinicalTrials.gov registry record · Phase 3
Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
A Phase 3 study of Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 367
- Enrollment target
- 20
- Study locations
NCT03345914: Completed Phase 3 study of Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals.
NCT03345914 is a Phase 3 study of Dermatitis, Atopic that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 367 participants, roughly in line with the 384-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03345914, a Phase 3 study of Dermatitis, Atopic, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 367 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to \<12 years of age with severe atopic dermatitis (AD). The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to \<12 years of age with severe AD.
Primary Outcome
The IGA was an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at Week 16 were considered as a non-responder.
Conditions Studied
Interventions
- DRUG Dupilumab
- DRUG Matching Placebo
- OTHER Background Treatment: Topical Corticosteroids
- OTHER Background Treatment: Moisturizers
Study Locations (20)
California
- Regeneron Research Site - Bakersfield
- Regeneron Research Site - Long Beach
- Regeneron Research Site - Mission Viejo
- Regeneron Research Site - Rolling Hills Estates
- Regeneron Research Site - San Diego
Florida
- Regeneron Research Site - Coral Gables
- Regeneron Research Site - Tampa
- Regeneron Research Site - Tampa
Georgia
- Regeneron Research Site - Macon
- Regeneron Research Site - Sandy Springs
Illinois
- Regeneron Research Site - Chicago
- Regeneron Research Site - Normal
Alabama
- Regeneron Research Site - Birmingham
Arizona
- Regeneron Research Site - Gilbert
Colorado
- Regeneron Research Site - Denver
Maryland
- Regeneron Research Site - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 367 participants |
| Start Date | 2017-11-17 |
| Est. Completion | 2019-09-10 |
| Phase | Phase 3 |
What the finished NCT03345914 record still lists
NCT03345914 is an interventional study that assigns participants to a tested intervention. The registered 367 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 384-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target.
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 4 interventions - of which Dupilumab is the first listed.
NCT03345914 names 20 study sites across 12 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03345914 about?
NCT03345914 is a clinical study titled "Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)". The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to \<12 years of age with severe atopic dermatitis (AD). The secondary objective is to assess the safety of dupilumab administered conco...
What is the current status of trial NCT03345914?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 367 participants. The study started on 2017-11-17. Estimated completion is 2019-09-10.
What conditions does trial NCT03345914 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT03345914?
The interventions under investigation include: Dupilumab (DRUG), Matching Placebo (DRUG), Background Treatment: Topical Corticosteroids (OTHER), Background Treatment: Moisturizers (OTHER).
Who is sponsoring clinical trial NCT03345914?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345914 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, 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 NCT03345914's enrollment target sits among peer trials
367 10th of 29 higher than 20 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
-
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
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A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
ACTIVE NOT RECRUITING · Phase 3
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COMPLETED · Phase 3
-
Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
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Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
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