ConjunctivitisNCT04287608
Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
An observational study of Conjunctivitis and Atopic Dermatitis, run by Regeneron Pharmaceuticals at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Conjunctivitis, Atopic Dermatitis
- What is being tested?
- dupilumab
- How many people
- 50 participants
- Where
- 15 sitesUnited States
- Study dates
- 10 Mar 2021to 29 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Regeneron Study Site
Baltimore, Maryland, 21205
Regeneron Study Site
Boston, Massachusetts, 02114
Regeneron Study Site
Dallas, Texas, 75390-8575
Regeneron Study Site
Great Neck, New York, 11021
Regeneron Study Site
Houston, Texas, 77030
Regeneron Study Site
Irvine, California, 92697
Regeneron Study Site
Memphis, Tennessee, 38163
Regeneron Study Site
Miami, Florida, 33136
Regeneron Study Site
New Orleans, Louisiana, 70112
Regeneron Study Site
New York, New York, 10029
Regeneron Study Site
Palo Alto, California, 94303
Regeneron Study Site
Pasadena, California, 91105
Regeneron Study Site
Philadelphia, Pennsylvania, 19104
Regeneron Study Site
Pittsburgh, Pennsylvania, 15213
Regeneron Study Site
Portland, Oregon, 97239
About this study
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.
- Conditions
- Conjunctivitis, Atopic Dermatitis
- Being tested
- dupilumab
- Medical subject headings
- Conjunctivitis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dupilumabDrug
Also called DUPIXENT®, SAR231893, REGN668
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with qualifying conjunctivitis events | Not described Receives: Drug: dupilumab | |
| Patients with no clinical signs of eye inflammation | Not described Receives: Drug: dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Ophthalmologist Diagnosis
Diagnosis includes: symptoms and morphological features of conjunctivitis
Measured: Initial Visit (Day 1)
Proportion of patients in each category of ophthalmologist diagnoses
Symptoms / Morphological features
Measured: Initial Visit (Day 1)
Proportion of patients with symptoms
Symptoms include but are not limited to: infection, dry eye, cytological shifts, etc
Measured: 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.
Measured: 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.
Measured: Initial Visit (Day 1) up to week 52
Duration of conjunctivitis event(s) in patients whose conjunctivitis resolved
Measured: Up to week 52
Proportion of patients with conjunctivitis event resolution
Measured: Up to week 52
Proportion of patients who discontinued DUPIXENT® due to conjunctivitis events
Measured: 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
Measured: 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
Measured: Up to week 52 or resolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start10 Mar 2021
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConjunctivitisStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287608
- Sponsor's protocol ID
- R668-AD-1884
- Status last verified
- Apr 2023
- First submitted
- 25 Feb 2020
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40388089
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04287608
- Acronym / sponsor ID
- R668-AD-1884
- Conditions
- Conjunctivitis, Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with qualifying conjunctivitis events | – | Drug: dupilumab |
| Patients with no clinical signs of eye inflammation | – | Drug: dupilumab |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dupilumabAlso: DUPIXENT®, SAR231893, REGN668No 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. | Drug | Patients with no clinical signs of eye inflammation, Patients with qualifying conjunctivitis events |
Primary outcome
Baseline Ophthalmologist Diagnosis
Time frame: Initial Visit (Day 1)
Diagnosis includes: symptoms and morphological features of conjunctivitis
Proportion of patients in each category of ophthalmologist diagnoses
Time frame: Initial Visit (Day 1)
Symptoms / Morphological features
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
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.
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.
Duration of conjunctivitis event(s) in patients whose conjunctivitis resolved
Time frame: Up to week 52
Proportion of patients with conjunctivitis event resolution
Time frame: Up to week 52
Proportion of patients who discontinued DUPIXENT® due to conjunctivitis events
Time frame: Up to week 52
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 40388089Asbell 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conjunctivitis and Atopic Dermatitis, run by Regeneron Pharmaceuticals at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Ophthalmologist Diagnosis (time frame: Initial Visit (Day 1)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04287608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.