Evaluation of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)

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 beenmaintained stably for at least 2 weeks for topical corticosteroids, topical and oralantihistamines, topical mast cell stabilizers, and topical tacrolimus and at least 3months for topical and oral cyclosporine, and systemic corticosteroids. Such therapymust remain current throughout duration of study;
• have a history of AKC or atopic dermatitis with a diagnosis of AKC at Visit 1 (bymeeting inclusion 7 and 8);
• be able to self-administer or receive subcutaneous injections satisfactorily or have acaregiver at home routinely available for this purpose. If unable to administer athome, patients must be willing to come in to office to receive injections that do notcoincide with a visit;
• present signs of active disease, defined as one or more of the following in at leastone 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 marginredness ii. lid excoriation

• present symptoms of active disease, defined as having both of the following in atleast 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 testingperformed 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 controlthroughout the study duration and for at least 14 days prior to the first dose ofinvestigational product (Visit 2) and for 1 month after the last dose ofinvestigational product. Note: Women considered capable of becoming pregnant includeall females who have experienced menarche and have not experienced menopause (asdefined by amenorrhea for greater than 12 consecutive months) or have not undergonesuccessful surgical sterilization (hysterectomy, bilateral tubal ligation, orbilateral 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) asmeasured 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) ortheir 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 eithereye;
• have uncontrolled ocular hypertension or glaucoma in either eye;
• have prior (within 30 days of beginning investigational product) or anticipatedconcurrent use of an investigational product or device during the study period;
• have an ocular or systemic condition or a situation which, in the investigator'sopinion, may put the patient at increased risk, confound study data, or interferesignificantly with the patient's study participation;
• manifest in either eye symblepharon, significant conjunctival scarring, and/or fornixshortening;
• have planned surgery (ocular or systemic) during the trial period or within 30 daysafter the study period;
• have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHgor ≤ 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 toa 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 thestudy.