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Clinical trial

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

ID
Name
R668-AD-1884
Description
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.
Trial arms
Trial start
2021-03-10
Estimated PCD
2023-03-29
Trial end
2023-03-29
Status
Completed
Treatment
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.
Arms:
Patients with no clinical signs of eye inflammation, Patients with qualifying conjunctivitis events
Other names:
DUPIXENT®, SAR231893, REGN668
Size
50
Primary endpoint
Baseline Ophthalmologist Diagnosis
Initial Visit (Day 1)
Proportion of patients in each category of ophthalmologist diagnoses
Initial Visit (Day 1)
Proportion of patients with symptoms
Initial Visit (Day 1) up to week 52
Proportion of patients with morphological features
Initial Visit (Day 1) up to week 52
Proportion of conjunctivitis events by severity
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.
Up to week 52
Change in eosinophil counts and other cells identified by impression cytology from the conjunctival tissue
Up to week 52 or resolution
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-04-28

1 organization

1 product

2 indications

Product
dupilumab
Indication
Conjunctivitis
Indication
Atopic Dermatitis
Organization
Regeneron Pharmaceuticals