Clinical trial NCT04287608: Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
Official title: Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conjunctivitis
Atopic Dermatitis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2020-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll DUPIXENT®-treated patients with protocol-specified conjunctivitis events as well as reference patients with no clinical signs of conjunctivitis. Study participants will be recruited from patients being treated with DUPIXENT® for AD according to US Prescribing Information in the real-world setting, who develop conjunctivitis on treatment. These patients will be recruited with the help of a referral network of dermatologists and other physicians who treat patients with moderate-to-severe AD.

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

* Treatment with DUPIXENT® for AD (per the current US Prescribing Information) should be ongoing, and have been initiated at least 8 weeks prior to study enrollment. NOTE: A single missed dose in the 8 weeks prior to enrollment is allowed.
* Patients with protocol-specified conjunctivitis events must present with active bilateral conjunctivitis (with or without cornea or eyelid involvement) diagnosed by the ophthalmologist (investigator) which meets all of the following criteria:
* Developed (or significantly worsened) while receiving treatment with DUPIXENT® for AD
* Is clinically significant (eg, moderate-to-severe, extensive, persistent, etc) as determined by the investigator
* There is a suspected causal relationship between DUPIXENT® and conjunctivitis because:
* Conjunctivitis is a new-onset condition or an unusual worsening of a preexisting condition (eg, significantly more severe, more extensive, or more protracted than ever before) AND
* No alternative explanation is more plausible, in the opinion of the investigator
* Reference patients must have AD treated with current ongoing treatment with DUPIXENT® for equal or longer duration as compared to group 1, with no clinical signs of ocular inflammation noted during the entire DUPIXENT® treatment

Key Exclusion Criteria:

* Any known medical, social, or personal limitations that are likely to restrict the patient's ability to undergo study visits and complete study procedures (as assessed by the investigator), including hypersensitivity or other contraindications to the anesthetic eye drops used during the ophthalmological examination.

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Baseline Ophthalmologist Diagnosis
timeFrame: Initial Visit (Day 1)
measure: Proportion of patients in each category of ophthalmologist diagnoses
timeFrame: Initial Visit (Day 1)
measure: Proportion of patients with symptoms
timeFrame: Initial Visit (Day 1) up to week 52
measure: Proportion of patients with morphological features
timeFrame: Initial Visit (Day 1) up to week 52
measure: Proportion of conjunctivitis events by severity
timeFrame: Initial Visit (Day 1) up to week 52
measure: Duration of conjunctivitis event(s) in patients whose conjunctivitis resolved
timeFrame: Up to week 52
measure: Proportion of patients with conjunctivitis event resolution
timeFrame: Up to week 52
measure: Proportion of patients who discontinued DUPIXENT® due to conjunctivitis events
timeFrame: Up to week 52
measure: Ophthalmologists assessment of treatment effectiveness, overall and by clinical phenotype based on a 5-point scale.
timeFrame: Up to week 52
measure: Change in eosinophil counts and other cells identified by impression cytology from the conjunctival tissue
timeFrame: Up to week 52 or resolution
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Regeneron Study Site
state: California
city: Palo Alto
country: United States
facility: Regeneron Study Site
state: California
city: Pasadena
country: United States
facility: Regeneron Study Site
state: California
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: New Orleans
country: United States
facility: Regeneron Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Regeneron Study Site
state: Maryland
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Great Neck
country: United States
facility: Regeneron Study Site
state: New York
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: Portland
country: United States
facility: Regeneron Study Site
state: Oregon
city: Philadelphia
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Regeneron Study Site
state: Pennsylvania
city: Memphis
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Dallas
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: