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

Study Purpose

This is a Phase 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 patients with active eosinophilic duodenitis. 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Provide written informed consent. 2. Male or female aged ≥18 and ≤80 years at the time of signing the informed consent for entry. 3. Baseline endoscopic biopsy with ≥30 eosinophils/hpf in 3 hpf in the duodenum, as determined by central histology assessment of biopsies collected during the screening EGD + colonoscopy, without any other significant cause for the eosinophilia. 4. Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening. 5. A weekly average score of abdominal pain, nausea, or diarrhea ≥3 on the PRO questionnaire (score from 0-10) for at least 2 weeks of screening and a weekly average TSS of ≥10 for at least 2 weeks of screening. 6. Inadequate or loss of response to, or intolerant to standard therapies for EoD symptoms, which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others. 7. If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study. 8. Willing and able to comply with all study procedures and visit schedule including follow-up visits. 9. Female patients 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 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 later menstrual period) at any time during study participation.

Exclusion Criteria:

1. Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day prednisone within 4 weeks prior to the screening visit. 2. Baseline endoscopic biopsy with ≥30 eosinophils/hpf in 5 hpf in the gastric mucosa as determined by central histology assessment of biopsies collected during the screening EGD. 3. Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to the screening visit. 4. Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit. 5. Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug. 6. Active Helicobacter pylori infection, unless treated and confirmed to be negative by repeat EGD (for baseline eosinophil count) prior to randomization and symptoms remain consistent. 7. History of inflammatory bowel disease, other chronic inflammatory diseases in the colon (with the exception of eosinophilic colitis), celiac disease, achalasia, or esophageal surgery. 8. History of bleeding disorders and/or esophageal varices. 9. Other causes of duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis. 10. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 11. Presence of an abnormal laboratory value considered to be clinically significant by the Investigator. 12. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk. 13. History of malignancy, except carcinoma in situ, early stage prostate cancer, or non-melanoma skin cancers. However, patients with cancers that have been in remission for more than 5 years and are considered cured can be enrolled. 14. Treatment for a clinically significant helminthic parasitic infection within 6 months of screening. 15. Positive helminthic infection on Ova and Parasite (O&P) test. 16. Seropositive for Strongyloides stercoralis at screening. 17. Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved hepatitis, at screening. 18. 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 study drug administration. This exclusion criterion does not apply to all types and formulations of vaccines (including live attenuated vaccines) authorized by FDA or other regulatory authority for the prevention of COVID-19, which may be administered before, during, or after the study. 19. Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products). 20. Known history of alcohol, drug, or other substance abuse or dependence that is considered by the Investigator to be ongoing and clinically significant. 21. Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04856891
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Allakos Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Craig Paterson, MD
Principal Investigator Affiliation Allakos Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Duodenitis, Eosinophilic Gastroenteritis
Arms & Interventions

Arms

Experimental: 3.0 mg/kg of Lirentelimab (AK002)

Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) at 3 mg/kg.

Placebo Comparator: Placebo

Subjects in this arm will receive 6 monthly doses of placebo at 3 mg/kg.

Interventions

Drug: - AK002

Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8.

Other: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Allakos Investigational Site, Birmingham, Alabama

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Allakos Investigational Site

Birmingham, Alabama, 35209

Allakos Investigational Site, Gilbert, Arizona

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Address

Allakos Investigational Site

Gilbert, Arizona, 85234

Allakos Investigational Site, Chula Vista, California

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Address

Allakos Investigational Site

Chula Vista, California, 91910

Allakos Investigational Site, Lomita, California

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Address

Allakos Investigational Site

Lomita, California, 90717

Allakos Investigational Site, Wheat Ridge, Colorado

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Address

Allakos Investigational Site

Wheat Ridge, Colorado, 80033

Allakos Investigational Site, Bristol, Connecticut

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Allakos Investigational Site

Bristol, Connecticut, 06010

Allakos Investigational Site, Hamden, Connecticut

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Allakos Investigational Site

Hamden, Connecticut, 06518

Allakos Investigational Site, Brandon, Florida

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Allakos Investigational Site

Brandon, Florida, 33511

Allakos Investigational Site, Edgewater, Florida

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Allakos Investigational Site

Edgewater, Florida, 32132

Allakos Investigational Site, Jacksonville, Florida

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Allakos Investigational Site

Jacksonville, Florida, 32256

Allakos Investigational Site, Kissimmee, Florida

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Allakos Investigational Site

Kissimmee, Florida, 34741

Allakos Investigational Site, Lakewood Ranch, Florida

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Allakos Investigational Site

Lakewood Ranch, Florida, 34211

Allakos Investigational Site, New Port Richey, Florida

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Allakos Investigational Site

New Port Richey, Florida, 34653

Allakos Investigational Site, Ponte Vedra, Florida

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Address

Allakos Investigational Site

Ponte Vedra, Florida, 32081

Allakos Investigational Site, Crowley, Louisiana

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Allakos Investigational Site

Crowley, Louisiana, 70526

Allakos Investigational Site, Reno, Nevada

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Allakos Investigational Site

Reno, Nevada, 89511

Allakos Investigational Site, Florham Park, New Jersey

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Address

Allakos Investigational Site

Florham Park, New Jersey, 07932

Allakos Investigational Site, Great Neck, New York

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Address

Allakos Investigational Site

Great Neck, New York, 11023

Allakos Investigational Site, Concord, North Carolina

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Allakos Investigational Site

Concord, North Carolina, 28027

Allakos Investigational Site, Durham, North Carolina

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Address

Allakos Investigational Site

Durham, North Carolina, 27710

Allakos Investigational Site, Cincinnati, Ohio

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Address

Allakos Investigational Site

Cincinnati, Ohio, 45219

Allakos Investigational Site, Cincinnati, Ohio

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Address

Allakos Investigational Site

Cincinnati, Ohio, 45231

Allakos Investigational Site, Dayton, Ohio

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Allakos Investigational Site

Dayton, Ohio, 45415

Allakos Investigational Site, Mentor, Ohio

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Allakos Investigational Site

Mentor, Ohio, 44094

Allakos Investigational Site, Greenwood, South Carolina

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Allakos Investigational Site

Greenwood, South Carolina, 29646

Allakos Investigational Site, Chattanooga, Tennessee

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Allakos Investigational Site

Chattanooga, Tennessee, 37421

Allakos Investigational Site, Hermitage, Tennessee

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Allakos Investigational Site

Hermitage, Tennessee, 37076

Allakos Investigational Site, Hixson, Tennessee

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Allakos Investigational Site

Hixson, Tennessee, 37343

Allakos Investigational Site, Austin, Texas

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Address

Allakos Investigational Site

Austin, Texas, 78745

Allakos Investigational Site, Cedar Park, Texas

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Address

Allakos Investigational Site

Cedar Park, Texas, 78613

Allakos Investigational Site, Fort Worth, Texas

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Address

Allakos Investigational Site

Fort Worth, Texas, 76104

Allakos Investigational Site, Lubbock, Texas

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Address

Allakos Investigational Site

Lubbock, Texas, 79410

Allakos Investigational Site, San Antonio, Texas

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Address

Allakos Investigational Site

San Antonio, Texas, 78229

Allakos Investigational Site, Southlake, Texas

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Address

Allakos Investigational Site

Southlake, Texas, 76092

Allakos Investigational Site, Webster, Texas

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Address

Allakos Investigational Site

Webster, Texas, 77598

Allakos Investigational Site, Ogden, Utah

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Address

Allakos Investigational Site

Ogden, Utah, 84405

Allakos Investigational Site, Salt Lake City, Utah

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Address

Allakos Investigational Site

Salt Lake City, Utah, 84132

Allakos Investigational Site, Sandy, Utah

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Address

Allakos Investigational Site

Sandy, Utah, 84092

Allakos Investigational Site, Fredericksburg, Virginia

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Address

Allakos Investigational Site

Fredericksburg, Virginia, 22401

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