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

  • End date
    Dec 13, 2022
  • participants needed
  • sponsor
    Regeneron Pharmaceuticals
Updated on 22 April 2022


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.

Condition Conjunctivitis, Atopic Dermatitis
Treatment Dupilumab
Clinical Study IdentifierNCT04287608
SponsorRegeneron Pharmaceuticals
Last Modified on22 April 2022


Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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