A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis


Trial ID: NCT03379311


This is a Phase 1b, open-label, study to assess the effects of AK002, given as monthly intravenous infusion for 6 doses at up to 3 mg/kg.

Official Title

A Phase 1b, Open-Label, Multiple Dose, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis

Stanford Investigator(s)

Charles C. Lin, MD
Charles C. Lin, MD

Clinical Associate Professor, Ophthalmology


Inclusion Criteria:

   1. Provided written informed consent

   2. Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form

   3. Confirmed diagnosis of AKC, VKC, or PAC and an average total ACS score of ≥15
   calculated from all daily ACS questionnaires completed during the screening period
   (minimum of 14 daily ACS questionnaires must be completed). Total ACS score is the sum
   of itching, light sensitivity, eye pain, foreign body sensation, and watering symptom
   scores (and excludes atopic dermatitis, allergic asthma, and allergic rhinitis

   4. History of topical corticosteroid and/or systemic corticosteroid use for the treatment
   of allergic conjunctivitis (AKC, VKC, or PAC)

   5. Stable dose(s) of allowed AKC, VKC, or PAC medication(s) during the 14 days prior to
   Day 1; and commitment to remaining on the same dose(s) of AKC, VKC, or PAC
   medication(s) for the entire duration of study participation (unless dose modification
   is due to unforeseen medical necessity) per Section 8.1 and Section 8.2.

   6. Willing and able to comply with the study procedures and visit schedule, including
   follow-up visits

   7. Negative Screening ova and parasite test

   8. Female patients must be either post-menopausal for at least 1 year with FSH level >40
   mIU/mL at Screening or surgically sterile (tubal ligation, hysterectomy or bilateral
   oophorectomy) for at least 3 months, or if of child-bearing potential, have a negative
   pregnancy test and agree to use dual methods of contraception, or abstain from sexual
   activity from Screening until the end of the study, or for 120 days following the last
   dose of study drug, whichever is longer.

Male patients with female partners of childbearing potential must agree to use a highly
effective method of contraception from Screening until the end of the study or for 120 days
following the last dose of study drug, whichever is longer. All fertile men with female
partners of childbearing potential should be instructed to contact the Investigator
immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual
period) at any time during study participation.

Exclusion Criteria:

   1. Known hypersensitivity to any constituent of the study drug

   2. Women who are pregnant, breastfeeding, or planning to become pregnant while
   participating in the study

   3. Presence of abnormal laboratory values considered to be clinically significant by the

   4. Any disease or condition (medical or surgical) which, in the opinion of the
   Investigator, would place the patient at increased risk

   5. History of malignancy, exempting: carcinoma in situ in the cervix, early stage
   prostate cancer, non-melanoma skin cancers, or cancers that have been in remission for
   more than 5 years and are considered cured (except for breast cancer). All history of
   malignancy (including diagnosis, dates, and compliance with cancer screening
   recommendations) must be documented and certified by the Investigator.

   6. Contact lens use within 48 hours prior to first AK002 dose

   7. Participation in a concurrent interventional study with the last intervention
   occurring within 30 days prior to administration of study drug (or 90 days or 5
   half-lives, whichever is longer, for biologic products)

   8. Treatment with chemotherapy or radiotherapy in the preceding 6 months

   9. Treatment for a clinically significant helminthic parasitic infection within 6 months
   of screening

10. Use during the 30 days before Screening (or 5 half-lives, whichever is longer) or use
   during the Screening period of topical decongestants, topical vasoconstrictors,
   topical calcineurin inhibitors, topical corticosteroids*, omalizumab, dupilumab,
   systemic immunosuppressive drugs, or systemic corticosteroids with a daily dose >10 mg
   prednisone or equivalent per Section 8.1 and Section 8.2

   *Topical corticosteroids for atopic dermatitis, corticosteroid nasal sprays for
   rhinitis, and inhaled corticosteroids for allergic asthma are allowed.

11. Vaccination with live attenuated vaccines within 30 days prior to initiation of
   treatment in the study, during the treatment period, or vaccination expected within 5
   half-lives (4 months) of the study drug administration

12. Positive hepatitis serology results, except for vaccinated patients or patients with
   past but resolved hepatitis, at Screening

13. Positive HIV serology results at Screening

14. Known history of alcohol, drug, or other substance abuse or dependence

15. Any other reason that (in the opinion of the Investigator or Medical Monitor) makes
   the patient unsuitable for enrollment


drug: AK002


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lisa Greer