Eosinophilic EsophagitisPhase 2/3KRYPTOSNCT04322708

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

A Phase 2/3 study testing lirentelimab (AK002) in people with Eosinophilic Esophagitis, run by Allakos Inc. at 78 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 to 80 years
Conditions the study is for: Eosinophilic Esophagitis
What is being tested?: lirentelimab (AK002)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 277 participants
Where: 78 sitesin 3 countries
Study dates: 6 Jul 2020to 18 Jan 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female aged ≥12 and ≤80 years at the time of signing ICF.
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.
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.
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.
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.
If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study, as much as possible.
Able and willing to comply with all study procedures.
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.

Who cannot join

Concomitant EG, EoD, or eosinophilic colitis (EC).
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.
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.
History of inflammatory bowel disease, celiac disease, achalasia, and/or esophageal surgery.
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.
History of bleeding disorders or esophageal varices.

Show all 22Show fewer

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.
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.
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.
Seropositive for HIV or hepatitis at Screening, except for vaccinated patients or patients with a history of hepatitis that has since resolved.
Prior exposure to AK002 or hypersensitivity to any constituent of AK002.
Change in dose of inhaled corticosteroids, nasal corticosteroids, PPI, and/or diet therapy within 4 weeks prior to Screening.
Use of oral corticosteroids (swallowed topical or systemic corticosteroids) within 8 weeks prior to Screening.
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.
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.
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.
Treatment with chemotherapy or radiotherapy in the preceding 6 months.
Presence of abnormal laboratory values considered by the Investigator to be clinically significant.
Any disease, condition (medical or surgical), or cardiac abnormality, which in the opinion of the Investigator, would place the subject at increased risk.
Known history of alcohol, drug, or other substance abuse or dependence.
Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
Any other reason that in the opinion of the Investigator or Medical Monitor makes the patient unsuitable for enrollment.

Trial locations and contacts

78 sites in 3 countries.

Country

City, postcode or hospital

78 sites in 3 countries

United States73 sites

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

Other trials in United States

Australia4 sites

Allakos Investigational Site
Adelaide, South Australia, 5000
Allakos Investigational Site
Box Hill, Victoria, 3128
Allakos Investigational Site
Elizabeth Vale, South Australia, 5112
Allakos Investigational Site
Prahran, Victoria, 3181

Other trials in Australia

Netherlands1 site

Allakos Investigational Site
Amsterdam, North Holland, 1105 AZ

Other trials in Netherlands

About this study

Official title: 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.

Conditions: Eosinophilic Esophagitis
Being tested: Placebo, lirentelimab (AK002)
Keywords: EoE, Eosinophil, Esophagitis
Medical subject headings: Eosinophilic Esophagitis, Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04322708
Study group	Role	What they receive
Placebo	Placebo comparator	Subjects in this arm will receive 6 monthly doses of placebo. Receives: Other: Placebo
1 mg/kg of lirentelimab (AK002)	Experimental	Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg). Receives: Drug: lirentelimab (AK002)
3 mg/kg of lirentelimab (AK002)	Experimental	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. Receives: Drug: lirentelimab (AK002)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
Measured: At Week 24
Change in Dysphagia Symptom Questionnaire (DSQ) Score From 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.
Measured: Baseline to Weeks 23-24

Secondary outcomes (8)

Percent Change in Peak Esophageal Intraepithelial Eosinophil Count From 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.
Measured: Baseline to Week 24
Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eosinophil/Hpf at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
Measured: At Week 24
Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/Hpf at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies.
Measured: At Week 24
Number of Treatment Responders
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
Measured: At Weeks 23-24 and Week 24, Respectively
Subjects Who Achieve >50% Reduction in DSQ Score From 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.
Measured: Weeks 23-24
Percent Change in DSQ Score From 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.
Measured: Baseline to Weeks 23-24
Change in Biweekly Mean DSQ Over Time Using MMRM
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.
Measured: Baseline to Weeks 23-24
Change in EoE Reference Score for Endoscopic Abnormalities (EREFS) From 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.
Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202018 Jan 2022

First posted26 Mar 2020
Study start6 Jul 2020
Primary completion4 Jun 2021
Study completion18 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Eosinophilic EsophagitisStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 277 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04322708
Sponsor's protocol ID: AK002-014
Acronym: KRYPTOS
Status last verified: Dec 2023
First submitted: 24 Mar 2020
Last updated: 2 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis

All Eosinophilic Esophagitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04322708
Acronym / sponsor ID: KRYPTOS / AK002-014
Conditions: Eosinophilic Esophagitis
Keywords: EoE, Eosinophil, Esophagitis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 277 participants (actual)
Lead sponsor: Allakos Inc.Industry (pharma, biotech, devices)
Study start: 6 Jul 2020 (actual)
Primary completion: 4 Jun 2021 (actual)
Study completion: 18 Jan 2022 (actual)
First posted: 26 Mar 2020 (actual)
Results: Posted 2 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboSubjects in this arm will receive 6 monthly doses of placebo.
1 mg/kg of lirentelimab (AK002)	Experimental	Drug: lirentelimab (AK002)Subjects in this arm will receive 6 monthly doses of lirentelimab (AK002) (1mg/kg).
3 mg/kg of lirentelimab (AK002)	Experimental	Drug: 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.

Who may qualify

Ages: 12 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Male or female aged ≥12 and ≤80 years at the time of signing ICF.
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.
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.
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.
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.

Key exclusion criteria (22 listed)

Concomitant EG, EoD, or eosinophilic colitis (EC).
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.
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.
History of inflammatory bowel disease, celiac disease, achalasia, and/or esophageal surgery.
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.

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
PlaceboPlacebo	Other	Placebo
lirentelimab (AK002)Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.	Drug	1 mg/kg of lirentelimab (AK002), 3 mg/kg of lirentelimab (AK002)

Primary outcome

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.
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.

8 secondary outcomes

Percent Change in Peak Esophageal Intraepithelial Eosinophil Count From Baseline to Week 24
Time frame: Baseline to Week 24
Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eosinophil/Hpf at Week 24
Time frame: At Week 24
Subjects Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eosinophils/Hpf at Week 24
Time frame: At Week 24
Number of Treatment Responders
Time frame: 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
Percent Change in DSQ Score From Baseline to Weeks 23-24
Time frame: Baseline to Weeks 23-24
Change in Biweekly Mean DSQ Over Time Using MMRM
Time frame: 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

Results and safety

Results posted to the registry on 2 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	92	89
1 mg/kg of Lirentelimab (AK002)	93	89
3 mg/kg of Lirentelimab (AK002)	91	85

Primary outcome: Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24

Time frame: At Week 24. Count of participants. Unit: Participants

Measure	1 mg/kg of Lirentelimab (AK002) n = 93	3 mg/kg of Lirentelimab (AK002) n = 91	Placebo n = 92
Value	86	80	10

1 mg/kg of Lirentelimab (AK002) vs Placebo: Percent Difference from Placebo: 81.6 (95% CI 71.5 to 89.0), p <0.0001, Fisher Exact
3 mg/kg of Lirentelimab (AK002) vs Placebo: Percent Difference from Placebo: 77.0 (95% CI 66.1 to 85.4), p <0.0001, Fisher Exact

Population analysed: Modified Intention-to-treat

Primary outcome: Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline to Weeks 23-24.

Time frame: Baseline to Weeks 23-24. Least squares mean (Standard Error). Unit: Score on a scale

Measure	1 mg/kg of Lirentelimab (AK002) n = 93	3 mg/kg of Lirentelimab (AK002) n = 91	Placebo n = 92
Value	-11.9 (1.8)	-17.4 (1.8)	-14.6 (1.8)

1 mg/kg of Lirentelimab (AK002) vs Placebo: LSM Difference from Placebo: 2.7 (95% CI -1.9 to 7.3), p = 0.2470, ANCOVA
3 mg/kg of Lirentelimab (AK002) vs Placebo: LSM Difference from Placebo: -2.8 (95% CI -7.3 to 1.8), p = 0.2372, ANCOVA

Population analysed: Modified Intention-to-treat

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 197. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 mg/kg of Lirentelimab (AK002)	4 of 93 (4.3%)	37 of 93 (39.8%)	0 of 93
3 mg/kg of Lirentelimab (AK002)	3 of 91 (3.3%)	39 of 91 (42.9%)	0 of 91
Placebo	2 of 92 (2.2%)	23 of 92 (25%)	0 of 92

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Eosinophilic Esophagitis

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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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.

Craig Paterson, MD study director

Allakos Inc.

78 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing lirentelimab (AK002) in people with Eosinophilic Esophagitis, run by Allakos Inc. at 78 sites in 3 countries.

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 8 inclusion and 22 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 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Australia, Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Subjects Who Achieve a Peak Esophageal Intraepithelial Count of ≤6 Eosinophils/Hpf at Week 24 (time frame: At Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04322708.

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 2 Jan 2024.