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

NCT04287608 | Completed FDA Drug

• 1 other identifier: R668-AD-1884
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 15

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.

Conditions

Conjunctivitis; Atopic Dermatitis

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Patients with qualifying conjunctivitis events

Drug: dupilumab

Patients with no clinical signs of eye inflammation

Drug: dupilumab

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.

Also known as: DUPIXENT®, SAR231893, REGN668

Patients with no clinical signs of eye inflammation; Patients with qualifying conjunctivitis events

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (15)

Regeneron Study Site

Irvine, California, 92697, United States

Location

Regeneron Study Site

Palo Alto, California, 94303, United States

Location

Regeneron Study Site

Pasadena, California, 91105, United States

Location

Regeneron Study Site

Miami, Florida, 33136, United States

Location

Regeneron Study Site

New Orleans, Louisiana, 70112, United States

Location

Regeneron Study Site

Baltimore, Maryland, 21205, United States

Location

Regeneron Study Site

Boston, Massachusetts, 02114, United States

Location

Regeneron Study Site

Great Neck, New York, 11021, United States

Location

Regeneron Study Site

New York, New York, 10029, United States

Location

Regeneron Study Site

Portland, Oregon, 97239, United States

Location

Regeneron Study Site

Philadelphia, Pennsylvania, 19104, United States

Location

Regeneron Study Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Regeneron Study Site

Memphis, Tennessee, 38163, United States

Location

Regeneron Study Site

Dallas, Texas, 75390-8575, United States

Location

Regeneron Study Site

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Asbell P, Akpek E, Chamberlain W, Chen Z, Lawless E, Van Spall M, Ozturk ZE, Shumel B. Conjunctivitis in Adults with Atopic Dermatitis Treated with Dupilumab: An Observational Study of Clinical Characteristics, Symptomatology, and Treatment. Adv Ther. 2025 Jul;42(7):3285-3305. doi: 10.1007/s12325-025-03209-4. Epub 2025 May 19.

  PMID: 40388089 DERIVED

MeSH Terms

Conditions

Conjunctivitis; Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: March 10, 2021
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

US (15)