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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with qualifying conjunctivitis events |
| ||
| Patients with no clinical signs of eye inflammation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Ophthalmologist Diagnosis | Diagnosis includes: symptoms and morphological features of conjunctivitis | Initial Visit (Day 1) |
| Proportion of patients in each category of ophthalmologist diagnoses | Symptoms / Morphological features | Initial Visit (Day 1) |
| Proportion of patients with symptoms | Symptoms include but are not limited to: infection, dry eye, cytological shifts, etc | Initial Visit (Day 1) up to week 52 |
| Proportion of patients with morphological features | 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. | Initial Visit (Day 1) up to week 52 |
| Proportion of conjunctivitis events by severity | 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. | 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 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Study Site | Irvine | California | 92697 | United States | ||
| Regeneron Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40388089 | Derived | Asbell P, Akpek E, Chamberlain W, Chen Z, Lawless E, Van Spall M, Ozturk ZE, Shumel B. Conjunctivitis in Adults with Atopic Dermatitis Treated with Dupilumab: An Observational Study of Clinical Characteristics, Symptomatology, and Treatment. Adv Ther. 2025 Jul;42(7):3285-3305. doi: 10.1007/s12325-025-03209-4. Epub 2025 May 19. |
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|
|
| 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. | Treatment Effectiveness assessed on a 5-point scale: Poor, Fair, Good, Very Good, Excellent | Up to week 52 |
| Change in eosinophil counts and other cells identified by impression cytology from the conjunctival tissue | Measured by conjunctival impression sample (EyeprimTM) for cytology and RNA sequencing | Up to week 52 or resolution |
| Palo Alto |
| California |
| 94303 |
| United States |
| Regeneron Study Site | Pasadena | California | 91105 | United States |
| Regeneron Study Site | Miami | Florida | 33136 | United States |
| Regeneron Study Site | New Orleans | Louisiana | 70112 | United States |
| Regeneron Study Site | Baltimore | Maryland | 21205 | United States |
| Regeneron Study Site | Boston | Massachusetts | 02114 | United States |
| Regeneron Study Site | Great Neck | New York | 11021 | United States |
| Regeneron Study Site | New York | New York | 10029 | United States |
| Regeneron Study Site | Portland | Oregon | 97239 | United States |
| Regeneron Study Site | Philadelphia | Pennsylvania | 19104 | United States |
| Regeneron Study Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Regeneron Study Site | Memphis | Tennessee | 38163 | United States |
| Regeneron Study Site | Dallas | Texas | 75390-8575 | United States |
| Regeneron Study Site | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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