RECRUITING

Evaluation of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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)

Quick Facts

Study Start:2020-02-10

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04296864

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Kara Quealy

CONTACT

978-332-9417

kquealy@andovereye.org

Study Locations (Sites)

Premiere Practice Management, LLC

Los Angeles, California, 90013

United States

Colorado Eye Consultants/Corneal Consultants of Colorado

Littleton, Colorado, 80120

United States

Encore Medical Research, LLC

Hollywood, Florida, 33021

United States

Kannar Eye Care

Pittsburg, Kansas, 66762

United States

Andover Eye Associates

Andover, Massachusetts, 01810

United States

University of Michigan- Kellogg Eye Center

Ann Arbor, Michigan, 48105

United States

Silverstein Eye Centers

Kansas City, Missouri, 64133

United States

Ophthalmology Associates

Saint Louis, Missouri, 63131

United States

Mercy Clinic Eye Specialists

Springfield, Missouri, 65804

United States

St. Louis Eye Institute

Town And Country, Missouri, 63017

United States

Northwell Health Physician Partners Ophthalmology at Great Neck

Great Neck, New York, 11021

United States

Gerald W. Zaidman, MD

Hawthorne, New York, 10532

United States

NC Eye Associates

Apex, North Carolina, 27502

United States

Vita Eye Clinic

Shelby, North Carolina, 28150

United States

Tracie Malsom

Fargo, North Dakota, 58103

United States

Vantage EyeCare, LLC.

Bala-Cynwyd, Pennsylvania, 19004

United States

Blink Research Center

Memphis, Tennessee, 38119

United States

Advancing Vision Research, LLC

Smyrna, Tennessee, 37167

United States

Eye Associates of Central Texas

Round Rock, Texas, 78681

United States

Periman Eye Institute

Seattle, Washington, 98119

United States

Collaborators and Investigators

Sponsor: Andover Eye Associates

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-10

Study Completion Date2025-01

Study Record Updates

Study Start Date2020-02-10

Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

Atopic Keratoconjunctivitis