Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
Part of paid clinical trials in Irvine, California.
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT04287608
- Status
- Completed
Conditions
- Atopic Dermatitis
- Conjunctivitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- dupilumab — DRUGNo investigational agents will be provided to study patients, and no specific treatment is required during the study. DUPIXENT®-treated patients will receive DUPIXENT as standard of care for the treatment of their AD, as prescribed by their physician. However, continuous treatment with dupilumab for at least 8 weeks is required as a condition for eligibility.
Study Details
The primary objective of the study is to characterize the clinical phenotype(s) of DUPIXENT®-associated conjunctivitis events. The secondary objectives of the study are to characterize the course of conjunctivitis events during the observation period and collect and assess data on treatment for conjunctivitis events and its effectiveness.
Key Dates
- Start date
- Mar 10, 2021
- Status verified
- Apr 2023
- Primary completion
- Mar 29, 2023
- Completion
- Mar 29, 2023
Study Design
- Enrollment
- 50 participants (actual)
Arms
- Arm: Patients with qualifying conjunctivitis events
- Arm: Patients with no clinical signs of eye inflammation
Primary Outcome Measure
Baseline Ophthalmologist Diagnosis [ Time Frame: Initial Visit (Day 1) ]
Locations (15)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Regeneron Study Site | Irvine | California | 92697 | - |
| Regeneron Study Site | Palo Alto | California | 94303 | - |
| Regeneron Study Site | Pasadena | California | 91105 | - |
| Regeneron Study Site | Miami | Florida | 33136 | - |
| Regeneron Study Site | New Orleans | Louisiana | 70112 | - |
| Regeneron Study Site | Baltimore | Maryland | 21205 | - |
| Regeneron Study Site | Boston | Massachusetts | 02114 | - |
| Regeneron Study Site | Great Neck | New York | 11021 | - |
| Regeneron Study Site | New York | New York | 10029 | - |
| Regeneron Study Site | Portland | Oregon | 97239 | - |
| Regeneron Study Site | Philadelphia | Pennsylvania | 19104 | - |
| Regeneron Study Site | Pittsburgh | Pennsylvania | 15213 | - |
| Regeneron Study Site | Memphis | Tennessee | 38163 | - |
| Regeneron Study Site | Dallas | Texas | 75390-8575 | - |
| Regeneron Study Site | Houston | Texas | 77030 | - |
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