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NCT02260986 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
A Phase 3 study of Atopic Dermatitis, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 740
- Enrollment target
- 20
- Study locations
NCT02260986: Completed Phase 3 study of Atopic Dermatitis, sponsored by Regeneron Pharmaceuticals.
NCT02260986 is a Phase 3 study of Atopic Dermatitis that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 740 participants, above the 605-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02260986, a Phase 3 study of Atopic Dermatitis, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 740 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.
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 "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported.
Conditions Studied
Interventions
- DRUG Dupilumab
- DRUG Placebo (for Dupilumab)
- OTHER Topical Corticosteroid (TCS)
Study Locations (20)
Florida
- - Edgewater
- - Lake Worth
- - Miami Lakes
- - Orlando
- - Tampa
California
- - Encinitas
- - Oceanside
- - Palmdale
- - San Diego
Georgia
- - Alpharetta
- - Columbus
- - Savannah
Arkansas
- - Hot Springs
- - Little Rock
Connecticut
- - New Haven
- - Trumbull
Indiana
- - Carmel
- - New Albany
Arizona
- - Phoenix
Illinois
- - West Dundee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 740 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
What the finished NCT02260986 record still lists
NCT02260986 is an interventional study that assigns participants to a tested intervention. The registered 740 participants enrollment target is mid-sized for trials with a published cap, above the 605-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 3 interventions - of which Dupilumab is the first listed.
NCT02260986 names 20 study sites across 8 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02260986 about?
NCT02260986 is a clinical study titled "Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis". The primary objective of the study was to demonstrate the efficacy of Dupilumab administered concomitantly with topical corticosteroid (TCS) through Week 16 in adult participants with moderate-to-severe atopic dermatitis (AD) compared to placebo administered concomitantly with TCS.
What is the current status of trial NCT02260986?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 740 participants. The study started on 2014-09. Estimated completion is 2016-10.
What conditions does trial NCT02260986 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT02260986?
The interventions under investigation include: Dupilumab (DRUG), Placebo (for Dupilumab) (DRUG), Topical Corticosteroid (TCS) (OTHER).
Who is sponsoring clinical trial NCT02260986?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02260986 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atopic Dermatitis
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 NCT02260986's enrollment target sits among peer trials
740 19th of 150 higher than 132 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis 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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