Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287608
• Other study ID #: R668-AD-1884
• Status: Completed
• Start date: March 10, 2021
• Est. completion date: March 29, 2023

Study information

• Verified date: April 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Conjunctivitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• dupilumab
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.

Locations

Country	Name	City	State
United States	Regeneron Study Site	Baltimore	Maryland
United States	Regeneron Study Site	Boston	Massachusetts
United States	Regeneron Study Site	Dallas	Texas
United States	Regeneron Study Site	Great Neck	New York
United States	Regeneron Study Site	Houston	Texas
United States	Regeneron Study Site	Irvine	California
United States	Regeneron Study Site	Memphis	Tennessee
United States	Regeneron Study Site	Miami	Florida
United States	Regeneron Study Site	New Orleans	Louisiana
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site	Palo Alto	California
United States	Regeneron Study Site	Pasadena	California
United States	Regeneron Study Site	Philadelphia	Pennsylvania
United States	Regeneron Study Site	Pittsburgh	Pennsylvania
United States	Regeneron Study Site	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Ophthalmologist Diagnosis	Diagnosis includes: symptoms and morphological features of conjunctivitis	Initial Visit (Day 1)
Primary	Proportion of patients in each category of ophthalmologist diagnoses	Symptoms / Morphological features	Initial Visit (Day 1)
Primary	Proportion of patients with symptoms	Symptoms include but are not limited to: infection, dry eye, cytological shifts, etc	Initial Visit (Day 1) up to week 52
Primary	Proportion of patients with morphological features	Morphological features include but are not limited to: bulbar redness, limbal redness, lid redness, lid roughness, etc. and associated conditions may include blepharitis, keratitis, etc.	Initial Visit (Day 1) up to week 52
Primary	Proportion of conjunctivitis events by severity	Severity is based on the nature of the event, intensity of signs and/or symptoms, current functional impairment, and potential long-term health hazards related to the event. 3-point scale: Mild, Moderate or Severe.	Initial Visit (Day 1) up to week 52
Primary	Duration of conjunctivitis event(s) in patients whose conjunctivitis resolved		Up to week 52
Primary	Proportion of patients with conjunctivitis event resolution		Up to week 52
Primary	Proportion of patients who discontinued DUPIXENT® due to conjunctivitis events		Up to week 52
Primary	Ophthalmologists assessment of treatment effectiveness, overall and by clinical phenotype based on a 5-point scale.	Treatment Effectiveness assessed on a 5-point scale: Poor, Fair, Good, Very Good, Excellent	Up to week 52
Primary	Change in eosinophil counts and other cells identified by impression cytology from the conjunctival tissue	Measured by conjunctival impression sample (EyeprimTM) for cytology and RNA sequencing	Up to week 52 or resolution