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NCT03054428 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
A Phase 3 study of Dermatitis, Atopic and Moderate-to-Severe Atopic Dermatitis, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 251
- Enrollment target
- 20
- Study locations
NCT03054428: Completed Phase 3 study of Dermatitis, Atopic and Moderate-to-Severe Atopic Dermatitis, sponsored by Regeneron Pharmaceuticals.
NCT03054428 is a Phase 3 study of Dermatitis, Atopic and Moderate-to-Severe Atopic Dermatitis that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 251 participants, below the 388-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03054428, a Phase 3 study of Dermatitis, Atopic and Moderate-to-Severe Atopic Dermatitis, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 251 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe AD.
Primary Outcome
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. \[Values after first rescue treatment used were set to missing. Participants wi
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dupilumab
Study Locations (20)
California
- Regeneron Investigational Site - Bakersfield
- Regeneron Investigational Site - Long Beach
- Regeneron Investigational Site - Rolling Hills Estates
- Regeneron Investigational Site - San Diego
- Regeneron Investigational Site - Santa Rosa
Indiana
- Regeneron Investigational Site - Evansville
- Regeneron Investigational Site - Indianapolis
- Regeneron Investigational Site - Plainfield
Colorado
- Regeneron Investigational Site - Centennial
- Regeneron Investigational Site - Denver
Georgia
- Regeneron Investigational Site - Macon
- Regeneron Investigational Site - Sandy Springs
Massachusetts
- Regeneron Investigational Site - Boston
- Regeneron Investigational Site - Boston
Alabama
- Regeneron Investigational Site - Birmingham
Arizona
- Regeneron Investigational Site - Gilbert
District of Columbia
- Regeneron Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2017-03-21 |
| Est. Completion | 2018-06-05 |
| Phase | Phase 3 |
What the finished NCT03054428 record still lists
NCT03054428 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, below the 388-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (35% lower).
The record links to 9 conditions, with Dermatitis, Atopic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03054428 names 20 study sites across 11 states, led by California, Indiana, Colorado.
Frequently Asked Questions
What is clinical trial NCT03054428 about?
NCT03054428 is a clinical study titled "Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis". The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ...
What is the current status of trial NCT03054428?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 251 participants. The study started on 2017-03-21. Estimated completion is 2018-06-05.
What conditions does trial NCT03054428 study?
This clinical trial studies the following conditions: Dermatitis, Atopic, Moderate-to-Severe Atopic Dermatitis, Hypersensitivity, Immediate, Dermatitis, Dermatitis Atopic, Eczema, Skin Diseases, Skin.
What interventions are being tested in trial NCT03054428?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG).
Who is sponsoring clinical trial NCT03054428?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03054428 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 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 NCT03054428's enrollment target sits among peer trials
251 13th of 29 higher than 17 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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