A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis (KRYPTOS)

December 13, 2023 updated by: Allakos Inc.

A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic Esophagitis

This is a Phase 2/3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult and adolescent patients with active eosinophilic esophagitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
277

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Allakos Investigational Site
      • Elizabeth Vale, South Australia, Australia, 5112
        • Allakos Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Allakos Investigational Site
      • Prahran, Victoria, Australia, 3181
        • Allakos Investigational Site
  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Allakos Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Allakos Investigational Site
      • Huntsville, Alabama, United States, 38801
        • Allakos Investigational Site
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Allakos Investigational Site
      • Phoenix, Arizona, United States, 85016
        • Allakos Investigational Site
      • Phoenix, Arizona, United States, 85021
        • Allakos Investigational Site
      • Scottsdale, Arizona, United States, 85251
        • Allakos Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Allakos Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • Allakos Investigational Site
      • Los Angeles, California, United States, 90025
        • Allakos Investigational Site
      • Oakland, California, United States, 94612
        • Allakos Investigational Site
      • Santa Monica, California, United States, 90404
        • Allakos Investigational Site
      • Tustin, California, United States, 92780
        • Allakos Investigational Site
      • Ventura, California, United States, 93003
        • Allakos Investigational Site
      • Walnut Creek, California, United States, 94598
        • Allakos Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Allakos Investigational Site
      • Centennial, Colorado, United States, 80112
        • Allakos Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Allakos Investigational Site
      • Edgewater, Florida, United States, 32132
        • Allakos Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Allakos Investigational Site
      • Miami, Florida, United States, 33176
        • Allakos Investigational Site
      • Orlando, Florida, United States, 32803
        • Allakos Investigational Site
      • Orlando, Florida, United States, 32806
        • Allakos Investigational Site
      • Tampa, Florida, United States, 33603
        • Allakos Investigational Site
      • Tampa, Florida, United States, 33615
        • Allakos Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Allakos Investigational Site
      • Columbus, Georgia, United States, 31904
        • Allakos Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Allakos Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Allakos Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Allakos Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Allakos Investigational Site
    • Louisiana
      • Crowley, Louisiana, United States, 70526
        • Allakos Investigational Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Allakos Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Allakos Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Allakos Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Allakos Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Allakos Investigational Site
      • Troy, Michigan, United States, 48098
        • Allakos Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Allakos Investigational Site
    • Montana
      • Kalispell, Montana, United States, 59901
        • Allakos Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Allakos Investigational Site
      • Reno, Nevada, United States, 89511
        • Allakos Investigational Site
    • New York
      • Great Neck, New York, United States, 11021
        • Allakos Investigational Site
      • New York, New York, United States, 10029
        • Allakos Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Allakos Investigational Site
      • Chapel Hill, North Carolina, United States, 27599
        • Allakos Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • Allakos Investigational Site
      • Charlotte, North Carolina, United States, 28277
        • Allakos Investigational Site
      • Durham, North Carolina, United States, 27710
        • Allakos Investigational Site
      • High Point, North Carolina, United States, 27262
        • Allakos Investigational Site
      • Rocky Mount, North Carolina, United States, 27804
        • Allakos Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44302
        • Allakos Investigational Site
      • Cincinnati, Ohio, United States, 45231
        • Allakos Investigational Site
      • Cincinnati, Ohio, United States, 45229
        • Allakos Investigational Site
      • Cleveland, Ohio, United States, 44106
        • Allakos Investigational Site
      • Dayton, Ohio, United States, 45415
        • Allakos Investigational Site
      • Mentor, Ohio, United States, 44060
        • Allakos Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Allakos Investigational Site
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Allakos Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Allakos Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Allakos Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Allakos Investigational Site
      • Hixson, Tennessee, United States, 37343
        • Allakos Investigational Site
      • Nashville, Tennessee, United States, 37212
        • Allakos Investigational Site
    • Texas
      • Austin, Texas, United States, 78704
        • Allakos Investigational Site
      • Garland, Texas, United States, 75044
        • Allakos Investigational Site
      • San Antonio, Texas, United States, 78229
        • Allakos Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Allakos Investigational Site
      • Riverton, Utah, United States, 84065
        • Allakos Investigational Site
      • Salt Lake City, Utah, United States, 84132
        • Allakos Investigational Site
      • Sandy, Utah, United States, 84092
        • Allakos Investigational Site
    • Virginia
      • Leesburg, Virginia, United States, 20176
        • Allakos Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Allakos Investigational Site
      • Seattle, Washington, United States, 98115
        • Allakos Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Male or female aged ≥12 and ≤80 years at the time of signing ICF.
  2. Confirmed diagnosis of EoE and esophageal intraepithelial eosinophilic infiltration of ≥15 eosinophils/hpf in 1 hpf from a biopsy collected during the Screening EGD without any other cause for the esophageal eosinophilia.
  3. History (by patient report) of an average of ≥2 episodes of dysphagia with intake of solid foods per week during the 4 weeks prior to Screening.
  4. Subjects must have failed or not be adequately controlled on standard of care treatments for EoE symptoms, which could include PPI, systemic or topical corticosteroids, and/or diet, among others.
  5. If on an allowed treatment for EoE, stable dose for at least 4 weeks prior to Screening and willingness to continue that dose for the study duration.
  6. If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study, as much as possible.
  7. Able and willing to comply with all study procedures.
  8. Female subjects must be either post-menopausal for at least 1 year with FSH level >30 mIU/mL at Screening or surgically sterile (tubal ligation,hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing 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 subjects 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 at any time during study participation.

Key Exclusion Criteria:

  1. Concomitant EG, EoD, or eosinophilic colitis (EC).
  2. EG and/or EoD (≥30 eosinophils/hpf in 5 hpf in the stomach and/or ≥30 eosinophils/hpf in 3 hpf in the duodenum) as determined by central histology assessment of biopsies collected during the Screening EGD.
  3. Causes of esophageal eosinophilia other than EoE or one the following: hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, or peripheral blood absolute eosinophil count of >1500 eosinophils/μL.
  4. History of inflammatory bowel disease, celiac disease, achalasia, and/or esophageal surgery.
  5. Any esophageal stricture unable to be passed with a standard diagnostic 9 mm to 10 mm upper endoscope or any critical esophageal stricture that requires dilation during screening.
  6. History of bleeding disorders or esophageal varices.
  7. History of malignancy; except carcinoma in situ, early stage prostate cancer, or non-melanoma skin cancers. However, cancers that have been in remission for more than 5 years and are considered cured, can be enrolled (with the exception of breast cancer). All history of malignancy (including diagnosis, dates, and compliance with cancer screening recommendations) must be documented and certified by the Investigator, along with the statement that in their clinical judgment the tissue eosinophilia is attributable to EGID, rather than recurrence of malignancy.
  8. Active Helicobacter pylori infection (as determined by central histology staining of the biopsy collected during the Screening EGD), unless treated and confirmed to be negative prior to randomization and symptoms remain consistent.
  9. Positive Ova and Parasite (O&P) test at Screening, seropositive for Strongyloides stercoralis at Screening, and/or treatment for a clinically significant helminthic parasitic infection within 6 months of Screening.
  10. Seropositive for HIV or hepatitis at Screening, except for vaccinated patients or patients with a history of hepatitis that has since resolved.
  11. Prior exposure to AK002 or hypersensitivity to any constituent of AK002.
  12. Change in dose of inhaled corticosteroids, nasal corticosteroids, PPI, and/or diet therapy within 4 weeks prior to Screening.
  13. Use of oral corticosteroids (swallowed topical or systemic corticosteroids) within 8 weeks prior to Screening.
  14. Use of any biologics or medications that may interfere with the study, such as immunosuppressive or immunomodulatory drugs including azathioprine, JAK inhibitors, 6-mercaptopurine, methotrexate, cyclosporine, tacrolimus, anti-TNF, anti-IL-4 receptor, e.g., dupilumab), anti-IL-5 (e.g., mepolizumab), anti-IL-5 receptor (e.g., benralizumab), anti-IL-13 (e.g., lebrikizumab), anti-IgE (e.g., omalizumab), within 12 weeks prior to Screening.
  15. 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.
  16. Vaccination with live attenuated vaccines ≤30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected ≤5 half-lives (≤4 months) following study drug administration.
  17. Treatment with chemotherapy or radiotherapy in the preceding 6 months.
  18. Presence of abnormal laboratory values considered by the Investigator to be clinically significant.
  19. Any disease, condition (medical or surgical), or cardiac abnormality, which in the opinion of the Investigator, would place the subject at increased risk.
  20. Known history of alcohol, drug, or other substance abuse or dependence.
  21. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
  22. Any other reason that in the opinion of the Investigator or Medical Monitor makes the patient unsuitable for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Subjects in this arm will receive 6 monthly doses of placebo.
Other: Placebo
Placebo
Experimental: 1 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Experimental: 3 mg/kg of lirentelimab (AK002)
Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002): A first dose of 1 mg/kg, followed by 5 monthly doses of 3 mg/kg.
Drug: lirentelimab (AK002)
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24
Time Frame: At Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
At Week 24
Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline to Weeks 23-24.
Time Frame: Baseline to Weeks 23-24
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Baseline to Weeks 23-24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count From Baseline to Week 24
Time Frame: Baseline to Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies. A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
Baseline to Week 24
Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eosinophil/Hpf at Week 24
Time Frame: At Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
At Week 24
Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/Hpf at Week 24
Time Frame: At Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
At Week 24
Number of Treatment Responders
Time Frame: At Weeks 23-24 and Week 24, Respectively
Treatment responders defined by >30% improvement in symptoms (DSQ) at Weeks 23-24 and peak intraepithelial eosinophilic count of ≤6 cells/hpf at Week 24
At Weeks 23-24 and Week 24, Respectively
Subjects Who Achieve >50% Reduction in DSQ Score From Baseline to Weeks 23-24
Time Frame: Weeks 23-24
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Weeks 23-24
Percent Change in DSQ Score From Baseline to Weeks 23-24
Time Frame: Baseline to Weeks 23-24
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Baseline to Weeks 23-24
Change in Biweekly Mean DSQ Over Time Using MMRM
Time Frame: Baseline to Weeks 23-24
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Baseline to Weeks 23-24
Change in EoE Reference Score for Endoscopic Abnormalities (EREFS) From Baseline to Week 24
Time Frame: Baseline to Week 24
EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allakos Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Craig Paterson, MD, Allakos Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AK002-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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