Evaluating Dupilumab for treating Atopic Keratoconjunctivitis

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)

This study is testing if Dupilumab can help people with atopic keratoconjunctivitis feel better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Andover Eye Associates (Industry-sponsored)
• Drugs / interventions: dupilumab
• Locations: 20 sites (Los Angeles, California and 19 other locations)
• Trial ID: NCT04296864 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of Dupilumab in patients suffering from atopic keratoconjunctivitis (AKC). It is a multi-center, double-masked, randomized, placebo-controlled study designed to assess the treatment's impact on the signs and symptoms of AKC. Participants will receive either Dupilumab or a placebo, and their responses will be monitored throughout the study. The trial aims to provide insights into how well Dupilumab can alleviate the condition compared to no treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a history of atopic keratoconjunctivitis or atopic dermatitis.

Not a fit: Patients who are not currently stable on their AKC treatments or those unable to self-administer injections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from atopic keratoconjunctivitis.

How similar studies have performed: Other studies have shown promise in using Dupilumab for similar allergic conditions, indicating potential success for this approach.

Eligibility criteria

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.

Where this trial is running

Los Angeles, California and 19 other locations

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• University of Michigan- Kellogg Eye Center — Ann Arbor, Michigan, United States (Withdrawn)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

Study contacts

• Study coordinator: Kara Quealy

Conditions Atopic Keratoconjunctivitis