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Evaluation of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC) | Clinical Trials | Clareo Health

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Evaluation of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)

NCT04296864•Andover Eye Associates

View on ClinicalTrials.gov

Summary

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•be at least 18 years of age at Visit 1 of either gender and any race or ethnicity;
•provide written informed consent and sign the HIPAA form;
•be willing and able to follow all instructions and attend all study visits;
•if on an active therapy for AKC prior to Visit 1, such treatment must have been maintained stably for at least 2 weeks for topical corticosteroids, topical and oral antihistamines, topical mast cell stabilizers, and topical tacrolimus and at least 3 months for topical and oral cyclosporine, and systemic corticosteroids. Such therapy must remain current throughout duration of study;
•have a history of AKC or atopic dermatitis with a diagnosis of AKC at Visit 1 (by meeting inclusion 7 and 8);
•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 signs of active disease, defined as one or more of the following in at least one eye at Visit 2 (baseline):
•1. \>/=2 score in conjunctival redness AND
•2. \>/=2 score in at least one of the following lid disease signs: i. lid margin redness ii. lid excoriation
•present symptoms of active disease, defined as having both of the following in at least one eye at Visit 2 (baseline):
+4 more criteria

Exclusion Criteria

•have known contraindications or sensitivity to the use of any of the study drug(s) or their components, or any other medications required by the protocol;
•wear contact lenses for at least 48 hours prior to and during the study trial period;
•have a corneal ulcer in either eye;
•have a presence or history of ocular herpes or varicella-zoster infections in either eye;
•have uncontrolled ocular hypertension or glaucoma in either eye;
•have prior (within 30 days of beginning investigational product) or anticipated concurrent use of an investigational product or device during the study period;
•have an ocular or systemic condition or a situation which, in the investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's study participation;
•manifest in either eye symblepharon, significant conjunctival scarring, and/or fornix shortening;
•have planned surgery (ocular or systemic) during the trial period or within 30 days after the study period;
•have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg) at Visit
+4 more criteria

Locations (20)

Premiere Practice Management, LLC

Los Angeles, California, United States

Colorado Eye Consultants/Corneal Consultants of Colorado

Littleton, Colorado, United States

Encore Medical Research, LLC

Hollywood, Florida, United States

Kannar Eye Care

Pittsburg, Kansas, United States

Andover Eye Associates

Andover, Massachusetts, United States

University of Michigan- Kellogg Eye Center

Ann Arbor, Michigan, United States

Silverstein Eye Centers

Kansas City, Missouri, United States

Mercy Clinic Eye Specialists

Springfield, Missouri, United States

Ophthalmology Associates

St Louis, Missouri, United States

St. Louis Eye Institute

Town and Country, Missouri, United States

Key Dates

Start Date

February 10, 2020

Primary Completion Date

January 1, 2025

Completion Date

January 1, 2025

Last Updated

January 30, 2024

Enrollment

ESTIMATED participants

Conditions

Atopic Keratoconjunctivitis

Interventions

Dupilumab

DRUG

Contacts

Kara Quealy

CONTACT

978-332-9417 kquealy@andovereye.org