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Completed

NCT Number: NCT04287608

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

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.

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Key information

Conditions

Conjunctivitis Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Conjunctival Diseases Dermatitis Dermatitis, Atopic Eye Diseases Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Regeneron Study Site, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab

Drug

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2020
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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