Evaluation of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)

Atopic Keratoconjunctivitis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296864
• Other study ID #: 18-290-0002
• Status: Recruiting
• Phase: Phase 2
• Start date: February 10, 2020
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Andover Eye Associates
• Contact: Kara Quealy
• Phone: 978-332-9417
• Email: kquealy[@]andovereye.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Keratoconjunctivitis
• Keratoconjunctivitis

Intervention

Drug:
• Dupilumab
monoclonal antibody

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	University of Michigan- Kellogg Eye Center	Ann Arbor	Michigan
United States	NC Eye Associates	Apex	North Carolina
United States	Vantage EyeCare, LLC.	Bala-Cynwyd	Pennsylvania
United States	Tracie Malsom	Fargo	North Dakota
United States	Northwell Health Physician Partners Ophthalmology at Great Neck	Great Neck	New York
United States	Gerald W. Zaidman, MD	Hawthorne	New York
United States	Encore Medical Research, LLC	Hollywood	Florida
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Colorado Eye Consultants/Corneal Consultants of Colorado	Littleton	Colorado
United States	Premiere Practice Management, LLC	Los Angeles	California
United States	Blink Research Center	Memphis	Tennessee
United States	Kannar Eye Care	Pittsburg	Kansas
United States	Eye Associates of Central Texas	Round Rock	Texas
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	Periman Eye Institute	Seattle	Washington
United States	Vita Eye Clinic	Shelby	North Carolina
United States	Advancing Vision Research, LLC	Smyrna	Tennessee
United States	Mercy Clinic Eye Specialists	Springfield	Missouri
United States	St. Louis Eye Institute	Town And Country	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Andover Eye Associates	Regeneron Pharmaceuticals, Statistics & Data Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of treatment responders	• Determination of the percentage of treatment responders as defined as meeting one or more of the below at the end of the 16-week treatment period (Visit 7) as compared to Visit 2 (baseline): = 1 grade improvement in lid margin redness (0-3 scale, NOT allowing half unit increments); = 1 grade improvement in lid excoriation (0-3 scale, NOT allowing half unit increments); = 1 grade improvement in lid thickening/lichenification (0-3 scale, NOT allowing half unit increments); = 1 grade improvement in changes in mucocutaneous junction (0-3 scale, NOT allowing half unit increments); = 4 grade improvement in a composite symptom score (the sum of scores for ocular itching, tearing/watery eyes, ocular discomfort, photophobia, and nonpurulent mucous discharge); >2 grade improvement in an individual symptom from Visit 2 (baseline)	Baseline to Week 16