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NCT02277769 · ClinicalTrials.gov registry record · Phase 3
Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 3 study of Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 708
- Enrollment target
- 20
- Study locations
NCT02277769: Completed Phase 3 study of Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals.
NCT02277769 is a Phase 3 study of Dermatitis, Atopic that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 708 participants, above the 373-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (90% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02277769, a Phase 3 study of Dermatitis, Atopic, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 708 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).
Primary Outcome
IGA is an assessment scale used to determine severity of 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 is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA s
Conditions Studied
Interventions
- DRUG Dupilumab
- DRUG Placebo (for Dupilumab)
Study Locations (20)
California
- - Bakersfield
- - Costa Mesa
- - Fremont
- - Long Beach
- - Los Angeles
- - Orange
- - Roseville
- - Temecula
Florida
- - Miami
- - Oviedo
- - Tampa
- - West Palm Beach
Georgia
- - Alpharetta
- - Atlanta
- - Columbus
Alabama
- - Anniston
- - Birmingham
Arizona
- - Phoenix
Connecticut
- - Trumbull
Illinois
- - Buffalo Grove
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 708 participants |
| Start Date | 2014-11-30 |
| Est. Completion | 2016-01-31 |
| Phase | Phase 3 |
What the finished NCT02277769 record still lists
NCT02277769 is an interventional study that assigns participants to a tested intervention. The registered 708 participants enrollment target is mid-sized for trials with a published cap, above the 373-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (90% higher).
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 2 interventions - of which Dupilumab is the first listed.
NCT02277769 names 20 study sites across 7 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02277769 about?
NCT02277769 is a clinical study titled "Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis". This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).
What is the current status of trial NCT02277769?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 708 participants. The study started on 2014-11-30. Estimated completion is 2016-01-31.
What conditions does trial NCT02277769 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT02277769?
The interventions under investigation include: Dupilumab (DRUG), Placebo (for Dupilumab) (DRUG).
Who is sponsoring clinical trial NCT02277769?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02277769 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, 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 NCT02277769's enrollment target sits among peer trials
708 6th of 29 higher than 24 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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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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