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COMPLETEDPHASE2/PHASE3

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

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

NCT04322708•Allakos Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - 80 years

Sex

ALL

Healthy Volunteers

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.

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.
+12 more criteria

Locations (78)

Allakos Investigational Site

Birmingham, Alabama, United States

Allakos Investigational Site

Huntsville, Alabama, United States

Allakos Investigational Site

Gilbert, Arizona, United States

Allakos Investigational Site

Phoenix, Arizona, United States

Allakos Investigational Site

Phoenix, Arizona, United States

Allakos Investigational Site

Scottsdale, Arizona, United States

Allakos Investigational Site

Little Rock, Arkansas, United States

Allakos Investigational Site

La Jolla, California, United States

Allakos Investigational Site

Los Angeles, California, United States

Allakos Investigational Site

Oakland, California, United States

Key Dates

Start Date

July 6, 2020

Primary Completion Date

June 4, 2021

Completion Date

January 18, 2022

Last Updated

January 2, 2024

Enrollment

277

ACTUAL participants

Conditions

Eosinophilic Esophagitis

Interventions

Placebo

OTHER

lirentelimab (AK002)

DRUG

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

NCT06693531

Eosinophilic Esophagitis (EoE)

View study

RECRUITING

Eosinophilic Gastrointestinal Disorders Registry

NCT05199532

Eosinophilic EsophagitisEosinophilic Gastroenteritis+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Eosinophilic Gastrointestinal Disorders Registry

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