Atopic KeratoconjunctivitisPhase 1KRONOSNCT03379311
A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis
A Phase 1 study testing AK002 in people with Atopic Keratoconjunctivitis and Vernal Keratoconjunctivitis, run by Allakos Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, Perennial Allergic Conjunctivitis
- What is being tested?
- AK002
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- 26 Feb 2018to 8 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided written informed consent
- Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form
- 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).
- History of topical corticosteroid and/or systemic corticosteroid use for the treatment of allergic conjunctivitis (AKC, VKC, or PAC)
- 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.
- Willing and able to comply with the study procedures and visit schedule, including follow-up visits
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- Negative Screening ova and parasite test
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Maryland, Department of Ophthalmology and Visual Sciences
Baltimore, Maryland, 21201
Riverside Clinical Research
Edgewater, Florida, 32132
Tauber Eye Center
Kansas City, Missouri, 64111
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, 07650
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
Ophthalmology Associates
St Louis, Missouri, 63131
Ocular Immunology and Uveitis Foundation
Waltham, Massachusetts, 02451
About this study
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
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.
- Conditions
- Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, Perennial Allergic Conjunctivitis
- Being tested
- AK002
- Keywords
- AKC, PAC, VKC
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK002Drug
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability by evaluating Clinical laboratory parameters and adverse events assessed using the CTCAE version 4.03
Measured: 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 outcomes (2)
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
Measured: 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)
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)
Measured: Throughout the study from screening to day 309 or early term visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start26 Feb 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic KeratoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allakos Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Quan D Nguyen, MD, MSc, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379311
- Sponsor's protocol ID
- AK002-005
- Acronym
- KRONOS
- Status last verified
- Aug 2019
- First submitted
- 14 Dec 2017
- Last updated
- 29 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03379311
- Acronym / sponsor ID
- KRONOS / AK002-005
- Conditions
- Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, Perennial Allergic Conjunctivitis
- Keywords
- AKC, PAC, VKC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Allakos Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provided written informed consent
- Male or female aged ≥18 and ≤80 years at the time of signing the informed consent form
- 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).
- History of topical corticosteroid and/or systemic corticosteroid use for the treatment of allergic conjunctivitis (AKC, VKC, or PAC)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK002AK002 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). | Drug | – |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quan D Nguyen, MD, MSc principal investigator
Stanford University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK002 in people with Atopic Keratoconjunctivitis and Vernal Keratoconjunctivitis, run by Allakos Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.