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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK002 | Drug | AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs). |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability by evaluating Clinical laboratory parameters and adverse events assessed using the CTCAE version 4.03 | Adverse events will be collected starting from the time of first study drug infusion and ending at Day 309 (±7 Days) or the ET Visit unless directed otherwise by Allakos |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacodynamics of AK002 in patients with AKC, VKC, or PAC as measured by changes from baseline in absolute peripheral blood counts of eosinophils and basophils | Starting pre-dose on day -1 to day 309 or early term visit | |
| To evaluate the pharmacodynamics of AK002 using the Allergic Conjunctivitis Symptom Questionnaire (ACS) |
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Inclusion Criteria:
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:
Known hypersensitivity to any constituent of the study drug
Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study
Presence of abnormal laboratory values considered to be clinically significant by the Investigator
Any disease or condition (medical or surgical) which, in the opinion of the Investigator, would place the patient at increased risk
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.
Contact lens use within 48 hours prior to first AK002 dose
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)
Treatment with chemotherapy or radiotherapy in the preceding 6 months
Treatment for a clinically significant helminthic parasitic infection within 6 months of screening
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.
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
Positive hepatitis serology results, except for vaccinated patients or patients with past but resolved hepatitis, at Screening
Positive HIV serology results at Screening
Known history of alcohol, drug, or other substance abuse or dependence
Any other reason that (in the opinion of the Investigator or Medical Monitor) makes the patient unsuitable for enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Quan D Nguyen, MD, MSc | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Palo Alto | California | 94303 | United States | ||
| Riverside Clinical Research |
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To evaluate the pharmacodynamics of AK002 in patients with AKC, VKC, or PAC as measured by changes from baseline symptoms associated with AKC, VKC, or PAC as measured daily by a disease-specific patient questionnaire, the Allergic Conjunctivitis Symptom Questionnaire (ACS) |
| Throughout the study from screening to day 309 or early term visit |
| Edgewater |
| Florida |
| 32132 |
| United States |
| University of Maryland, Department of Ophthalmology and Visual Sciences | Baltimore | Maryland | 21201 | United States |
| Ocular Immunology and Uveitis Foundation | Waltham | Massachusetts | 02451 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Metropolitan Eye Research and Surgery Institute | Palisades Park | New Jersey | 07650 | United States |
| UPMC Eye Center | Pittsburgh | Pennsylvania | 15213 | United States |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000654568 | AK002 |
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