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

Study Overview
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Brief Summary
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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.

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

Conditions
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Conjunctivitis, Atopic Dermatitis

Intervention / Treatment
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* Drug: dupilumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with qualifying conjunctivitis events<br> | Drug: dupilumab<br>* 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.<br>* Other names: REGN668;|
| Patients with no clinical signs of eye inflammation<br> | Drug: dupilumab<br>* 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.<br>* Other names: REGN668;|

What is the study measuring?
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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 |