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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04287608
Other study ID # R668-AD-1884
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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