Recruiting

Phase 2

DupilumabEvaluation of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)

Sponsor:

Andover Eye Associates

Code:

NCT04296864

Conditions

Atopic Keratoconjunctivitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Study Details

Brief 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).

Conditions

Atopic Keratoconjunctivitis

Study ID

NCT04296864

Start date

Feb 10, 2020

Status verified date

Jan, 2024

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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):

1. >/=2.5 score in ocular itching AND
2. >/=2 score for ocular discomfort;

(for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and at exit visit; must not be lactating; and must agree to use at least one medically acceptable form of birth control throughout the study duration and for at least 14 days prior to the first dose of investigational product (Visit 2) and for 1 month after the last dose of investigational product. Note: Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
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:

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
be a female who is currently pregnant, planning a pregnancy, or lactating;
have any previous exposure to dupilumab (unless discontinuation of exposure was due to a non-medical reason);
have treatment with a live (attenuated) vaccine during the study;
have an untreated parasitic (helminth) infection prior to Visit 2 and during the study.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo of Dupilumab

experimental: Dupilumab

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

Interventions

Dupilumab

monoclonal antibody

Primary outcome measure

Percentage of treatment responders [ Time Frame: Baseline to Week 16 ]

Central Contacts and Locations

Central contacts

Kara Quealy

978-332-9417 kquealy@andovereye.org

Locations

Premiere Practice Management, LLC

Recruiting

Los Angeles, California, United States, 90013

Colorado Eye Consultants/Corneal Consultants of Colorado

Recruiting

Littleton, Colorado, United States, 80120

Kannar Eye Care

Recruiting

Pittsburg, Kansas, United States, 66762

Andover Eye Associates

Recruiting

Andover, Massachusetts, United States, 01810

Silverstein Eye Centers

Recruiting

Kansas City, Missouri, United States, 64133

Ophthalmology Associates

Recruiting

Saint Louis, Missouri, United States, 63131

Mercy Clinic Eye Specialists

Recruiting

Springfield, Missouri, United States, 65804

St. Louis Eye Institute

Recruiting

Town And Country, Missouri, United States, 63017

Gerald W. Zaidman, MD

Recruiting

Hawthorne, New York, United States, 10532

NC Eye Associates

Recruiting

Apex, North Carolina, United States, 27502

Vita Eye Clinic

Recruiting

Shelby, North Carolina, United States, 28150

Tracie Malsom

Recruiting

Fargo, North Dakota, United States, 58103

Vantage EyeCare, LLC.

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Blink Research Center

Recruiting

Memphis, Tennessee, United States, 38119

Advancing Vision Research, LLC

Recruiting

Smyrna, Tennessee, United States, 37167

Periman Eye Institute

Recruiting

Seattle, Washington, United States, 98119

More Information

Sponsor

Andover Eye Associates

Last update posted

Jan 30, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Andover Eye Associates on 2024-01-30.