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

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ClinicalTrials.gov Identifier: NCT03379311
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Allakos, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atopic Keratoconjunctivitis Vernal Keratoconjunctivitis Perennial Allergic Conjunctivitis Drug: AK002 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye


Intervention Details:
  • Drug: AK002
    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).


Primary Outcome Measures :
  1. To evaluate the safety and tolerability by evaluating Clinical laboratory parameters and adverse events assessed using the CTCAE version 4.03 [ Time Frame: 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 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Starting pre-dose on day -1 to day 309 or early term visit ]
  2. To evaluate the pharmacodynamics of AK002 using the Allergic Conjunctivitis Symptom Questionnaire (ACS) [ Time Frame: Throughout the study from screening to day 309 or early term visit ]
    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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 scores).
  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 Investigator
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379311


Contacts
Contact: Henrik Rasmussen, MD, PhD 443-699-5230 hrasmussen@allakos.com

Locations
United States, California
Byers Eye Institute at Stanford University Recruiting
Palo Alto, California, United States, 94303
Contact: Lisa Greer         
Principal Investigator: Charles Lin, MD         
United States, Florida
Riverside Clinical Research Recruiting
Edgewater, Florida, United States, 32132
Contact: Tamie Ashby         
Principal Investigator: Susan Hole, DO         
United States, Maryland
University of Maryland, Department of Ophthalmology and Visual Sciences Recruiting
Baltimore, Maryland, United States, 21201
Contact: Bennie Jeng    667-214-1161      
United States, Massachusetts
Ocular Immunology and Uveitis Foundation Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Andrew Stephenson         
Principal Investigator: C.Stephen Foster, MD         
United States, Missouri
Tauber Eye Center Recruiting
Kansas City, Missouri, United States, 64111
Contact: Megan Hefter         
Principal Investigator: Joseph Tauber, MD         
Ophthalmology Associates Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Debi Gravemann         
Principal Investigator: Gregg Berdy, MD         
United States, New Jersey
Metropolitan Eye Research and Surgery Institute Recruiting
Palisades Park, New Jersey, United States, 07650
Contact: Yue Hao         
Principal Investigator: David Chu, MD         
United States, Pennsylvania
UPMC Eye Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Rhonda Dahlstrom         
Principal Investigator: Vishal Jhanji, MD         
Sponsors and Collaborators
Allakos, Inc.
Investigators
Principal Investigator: Quan D Nguyen, MD, MSc Stanford University

Responsible Party: Allakos, Inc.
ClinicalTrials.gov Identifier: NCT03379311     History of Changes
Other Study ID Numbers: AK002-005
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allakos, Inc.:
AKC
PAC
VKC

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Keratoconjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Keratitis
Corneal Diseases