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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 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

Present symptoms of active disease, defined as having both of the following in at least one eye at Visit 2 (baseline): >/=2.5 score in ocular itching AND >/=2 score for ocular discomfort

Must not have

Have uncontrolled ocular hypertension or glaucoma in either eye

Have treatment with a live (attenuated) vaccine during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 16

Awards & highlights

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.

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).

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

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I can self-inject medication or have someone to help me.

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I have significant itching and discomfort in at least one eye.

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I have red eyes and at least one sign of eyelid disease.

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I have been diagnosed with atopic keratoconjunctivitis or atopic dermatitis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have uncontrolled high eye pressure or glaucoma.

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I will not receive any live vaccines during the study.

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I am not allergic or sensitive to the study drugs or any required medications.

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I have an untreated worm infection.

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I have had eye infections caused by herpes or chickenpox.

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I am scheduled for surgery (eye or other) during or within 30 days after the trial.

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I have scarring or damage in my eye due to injury or disease.

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I am currently pregnant, planning to become pregnant, or breastfeeding.

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I have a corneal ulcer in one of my eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 16

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of treatment responders

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

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

~11960

0 / 13Eligibility criteria met

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

655 Previous Clinical Trials

385,225 Total Patients Enrolled

5 Trials studying Conjunctivitis

740 Patients Enrolled for Conjunctivitis

~1 spots leftby Jan 2025

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