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

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ClinicalTrials.gov Identifier: NCT04287608
Recruitment Status : Recruiting
First Posted : February 27, 2020
Last Update Posted : November 19, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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.


Condition or disease Intervention/treatment
Conjunctivitis Atopic Dermatitis Drug: dupilumab

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
Actual Study Start Date : March 10, 2021
Estimated Primary Completion Date : December 13, 2022
Estimated Study Completion Date : December 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Pinkeye
Drug Information available for: Dupilumab

Group/Cohort Intervention/treatment
Patients with qualifying conjunctivitis events Drug: 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.
Other Names:
  • DUPIXENT®
  • SAR231893
  • REGN668

Patients with no clinical signs of eye inflammation Drug: 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.
Other Names:
  • DUPIXENT®
  • SAR231893
  • REGN668




Primary Outcome Measures :
  1. Baseline Ophthalmologist Diagnosis [ Time Frame: Initial Visit (Day 1) ]
    Diagnosis includes: symptoms and morphological features of conjunctivitis

  2. Proportion of patients in each category of ophthalmologist diagnoses [ Time Frame: Initial Visit (Day 1) ]
    Symptoms / Morphological features

  3. Proportion of patients with symptoms [ Time Frame: Initial Visit (Day 1) up to week 52 ]
    Symptoms include but are not limited to: infection, dry eye, cytological shifts, etc

  4. Proportion of patients with morphological features [ Time Frame: Initial Visit (Day 1) up to week 52 ]
    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.

  5. Proportion of conjunctivitis events by severity [ Time Frame: Initial Visit (Day 1) up to week 52 ]
    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.

  6. Duration of conjunctivitis event(s) in patients whose conjunctivitis resolved [ Time Frame: Up to week 52 ]
  7. Proportion of patients with conjunctivitis event resolution [ Time Frame: Up to week 52 ]
  8. Proportion of patients who discontinued DUPIXENT® due to conjunctivitis events [ Time Frame: Up to week 52 ]
  9. Ophthalmologists assessment of treatment effectiveness, overall and by clinical phenotype based on a 5-point scale. [ Time Frame: Up to week 52 ]
    Treatment Effectiveness assessed on a 5-point scale: Poor, Fair, Good, Very Good, Excellent

  10. Change in eosinophil counts and other cells identified by impression cytology from the conjunctival tissue [ Time Frame: Up to week 52 or resolution ]
    Measured by conjunctival impression sample (EyeprimTM) for cytology and RNA sequencing



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287608


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, California
Regeneron Study Site Recruiting
Irvine, California, United States, 92697
Regeneron Study Site Recruiting
Palo Alto, California, United States, 94303
Regeneron Study Site Recruiting
Pasadena, California, United States, 91105
United States, Florida
Regeneron Study Site Recruiting
Miami, Florida, United States, 33136
United States, Louisiana
Regeneron Study Site Recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
Regeneron Study Site Recruiting
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Regeneron Study Site Recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Regeneron Study Site Recruiting
Great Neck, New York, United States, 11021
Regeneron Study Site Recruiting
New York, New York, United States, 10029
United States, Oregon
Regeneron Study Site Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Regeneron Study Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
Regeneron Study Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Regeneron Study Site Recruiting
Memphis, Tennessee, United States, 38163
United States, Texas
Regeneron Study Site Recruiting
Dallas, Texas, United States, 75390-8575
Regeneron Study Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04287608    
Other Study ID Numbers: R668-AD-1884
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Conjunctivitis
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases