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)
Overview
- Phase
- Phase 2
- Intervention
- Dupilumab
- Conditions
- Atopic Keratoconjunctivitis
- Sponsor
- Andover Eye Associates
- Enrollment
- 42
- Locations
- 20
- Primary Endpoint
- Percentage of treatment responders
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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).
Investigators
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):
- •\>/=2 score in conjunctival redness AND
- •\>/=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):
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
Arms & Interventions
Placebo
Placebo of Dupilumab
Intervention: Dupilumab
Dupilumab
one loading dose of Dupilumab 600 mg followed by Dupilumab 300 mg weekly for a total of 16 weeks
Intervention: Dupilumab
Outcomes
Primary Outcomes
Percentage of treatment responders
Time Frame: Baseline to Week 16
• 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)