Status:
COMPLETED
Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Conjunctivitis
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 29 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04287608
Start Date
March 10 2021
End Date
March 29 2023
Last Update
April 28 2023
Active Locations (15)
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1
Regeneron Study Site
Irvine, California, United States, 92697
2
Regeneron Study Site
Palo Alto, California, United States, 94303
3
Regeneron Study Site
Pasadena, California, United States, 91105
4
Regeneron Study Site
Miami, Florida, United States, 33136