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

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.

Study Overview

• Status: Completed
• Conditions: Conjunctivitis; Atopic Dermatitis
• Intervention / Treatment: Drug: dupilumab

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • Regeneron Study Site
    • Palo Alto, California, United States, 94303
      • Regeneron Study Site
    • Pasadena, California, United States, 91105
      • Regeneron Study Site
  • Florida
    • Miami, Florida, United States, 33136
      • Regeneron Study Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Regeneron Study Site
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Regeneron Study Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Regeneron Study Site
  • New York
    • Great Neck, New York, United States, 11021
      • Regeneron Study Site
    • New York, New York, United States, 10029
      • Regeneron Study Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Regeneron Study Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Regeneron Study Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Regeneron Study Site
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • Regeneron Study Site
  • Texas
    • Dallas, Texas, United States, 75390-8575
      • Regeneron Study Site
    • Houston, Texas, United States, 77030
      • Regeneron Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with qualifying conjunctivitis events	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.; Other Names: REGN668; SAR231893; DUPIXENT®
Patients with no clinical signs of eye inflammation	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.; Other Names: REGN668; SAR231893; DUPIXENT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Ophthalmologist Diagnosis	Diagnosis includes: symptoms and morphological features of conjunctivitis	Initial Visit (Day 1)
Proportion of patients in each category of ophthalmologist diagnoses	Symptoms / Morphological features	Initial Visit (Day 1)
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
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
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
Duration of conjunctivitis event(s) in patients whose conjunctivitis resolved		Up to week 52
Proportion of patients with conjunctivitis event resolution		Up to week 52
Proportion of patients who discontinued DUPIXENT® due to conjunctivitis events		Up to week 52
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
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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Conjunctival Diseases; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Conjunctivitis
• Other Study ID Numbers: R668-AD-1884

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No