← Back to Search

Monoclonal Antibodies

Dupilumab for Conjunctivitis

Phase 2
Recruiting
Research Sponsored by Andover Eye Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be at least 18 years of age at Visit 1 of either gender and any race or ethnicity
Be able to self-administer or receive subcutaneous injections satisfactorily or have a caregiver at home routinely available for this purpose. If unable to administer at home, patients must be willing to come in to office to receive injections that do not coincide with a visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 16
Awards & highlights

Study Summary

This trial will test whether Dupilumab is effective in treating the signs and symptoms of atopic keratoconjunctivitis (AKC), a type of eye inflammation.

Who is the study for?
Adults with active atopic keratoconjunctivitis (AKC) who can self-administer or receive injections, and are not pregnant or lactating. Participants must have stable AKC treatments prior to the study and agree to use birth control. Excluded are those with recent contact lens use, eye surgery, certain eye conditions, abnormal blood pressure, live vaccine treatment, untreated infections, drug sensitivities or other health risks.Check my eligibility
What is being tested?
The trial is testing Dupilumab's effectiveness in treating signs and symptoms of AKC compared to a placebo. It's a multi-center study where participants are randomly assigned to either the test drug or placebo without knowing which one they're receiving (double-masked).See study design
What are the potential side effects?
Dupilumab may cause side effects such as eye irritation or discomfort, inflammation around the eyes, headache, skin reactions at the injection site and possibly others that will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I can self-inject medication or have someone to help me.
Select...
I am not pregnant, not breastfeeding, and will use birth control during and after the study.
Select...
I can follow all study instructions and attend all visits.
Select...
I have significant itching and discomfort in at least one eye.
Select...
I have been on stable AKC treatment for the required time before the study starts.
Select...
I have red eyes and at least one sign of eyelid disease.
Select...
I have been diagnosed with atopic keratoconjunctivitis or atopic dermatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of treatment responders

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Placebo/Dupilumab
DB Period: Dupilumab
DB Period: Placebo
OLE Period: Dupilumab/Dupilumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
one loading dose of Dupilumab 600 mg followed by Dupilumab 300 mg weekly for a total of 16 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo of Dupilumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230

Find a Location

Who is running the clinical trial?

Statistics & Data CorporationUNKNOWN
4 Previous Clinical Trials
1,015 Total Patients Enrolled
Andover Eye AssociatesLead Sponsor
Regeneron PharmaceuticalsIndustry Sponsor
613 Previous Clinical Trials
379,716 Total Patients Enrolled
3 Trials studying Conjunctivitis
620 Patients Enrolled for Conjunctivitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other existing studies that have used Dupilumab?

"Dupilumab is being studied in 52 different medical trials, 14 of which are Phase 3 clinical studies. Many of the research sites for Dupilumab are located in Louisville, Kentucky; however, there are 2662 total locations running these kinds of tests."

Answered by AI

Does the FDA recognize Dupilumab as a safe medication?

"While Phase 2 trials don't have definitive evidence supporting a medication's efficacy, there is some data backing Dupilumab's safety. Therefore, it received a score of 2."

Answered by AI

What are some of the most common reasons doctors prescribe Dupilumab?

"Dupilumab is a medication that dermatologists often prescribe to patients with atopic dermatitis. It can also be used as a corticosteroid-sparing agent for eosinophilic asthma and other conditions."

Answered by AI

Is this study still looking for volunteers?

"Yes, that is correct. The trial information on clinicaltrials.gov indicates that the study is actively enrolling patients."

Answered by AI

Has this research been done before?

"There have been a total of 52 clinical trials completed or currently underway for Dupilumab as of right now. These studies are taking place in 455 cities across 43 countries. The first trial was conducted in 2015 by Sanofi and involved 880 individuals. This study reached the third stage of drug approval (Phase 3) and, since then, 54 more trials have concluded."

Answered by AI

How many research subjects are you following in this experiment?

"The information available on clinicaltrials.gov verifies that this study is still recruiting patients. The trial was posted on February 10th, 2020 and updated November 23rd, 2021. There are 42 spots open across 14 different enrolment centres."

Answered by AI

In how many different settings is this research being conducted?

"There are multiple locations looking for patients to enroll in this trial, including 14 different sites. For example, Eye Associates of Central Texas in Round Rock, Vita Eye Clinic in Shelby, and University of Michigan- Kellogg Eye Center in Ann Arbor are all currently recruiting."

Answered by AI
~7 spots leftby Jan 2025