Dupilumab for Conjunctivitis

Recruiting at 16 trial locations

Overseen By Kara Quealy

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Andover Eye Associates

Must be taking: Topical corticosteroids, oral antihistamines

Disqualifiers: Contact lenses, Corneal ulcer, Ocular herpes, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy, safety, and tolerability study evaluating the efficacy of Dupilumab in the treatment of signs and symptoms of atopic keratoconjunctivitis (AKC).

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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

Have a calculated visual acuity of 0.7 logarithm of the minimum angle of resolution (logMAR) or better in at least one eye (Snellen equivalent of 20/100) and 1.0 logMAR (or count fingers) or better in the fellow eye (Snellen equivalent of 20/200) as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart.

Exclusion Criteria

I have uncontrolled high eye pressure or glaucoma.

I will not receive any live vaccines during the study.

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

Treatment Details

Interventions

• Dupilumab

Trial Overview 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).

Participant Groups

Group I: Dupilumab Experimental Treatment 1 Intervention

one loading dose of Dupilumab 600 mg followed by Dupilumab 300 mg weekly for a total of 16 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo of Dupilumab

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Andover Eye Associates

Lead Sponsor

Trials

1

Recruited

40+

Statistics & Data Corporation

Collaborator

Trials

4

Recruited

1,000+

Statistics & Data Corporation

Industry Sponsor

Trials

5

Recruited

1,100+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School