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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • dupilumab — DRUG
    No 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)

FacilityCityStateZIPSite coordinators
Regeneron Study SiteIrvineCalifornia92697-
Regeneron Study SitePalo AltoCalifornia94303-
Regeneron Study SitePasadenaCalifornia91105-
Regeneron Study SiteMiamiFlorida33136-
Regeneron Study SiteNew OrleansLouisiana70112-
Regeneron Study SiteBaltimoreMaryland21205-
Regeneron Study SiteBostonMassachusetts02114-
Regeneron Study SiteGreat NeckNew York11021-
Regeneron Study SiteNew YorkNew York10029-
Regeneron Study SitePortlandOregon97239-
Regeneron Study SitePhiladelphiaPennsylvania19104-
Regeneron Study SitePittsburghPennsylvania15213-
Regeneron Study SiteMemphisTennessee38163-
Regeneron Study SiteDallasTexas75390-8575-
Regeneron Study SiteHoustonTexas77030-

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