Eosinophilic GastritisPhase 3NCT04620811

An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

A Phase 3 study testing lirentelimab in people with Eosinophilic Gastritis and Eosinophilic Duodenitis, run by Allakos Inc. at 38 sites in United States.

Completed

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

Official record

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Trial summary

This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Eosinophilic Gastritis, Eosinophilic Duodenitis
What is being tested?: lirentelimab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 38 sitesUnited States
Study dates: 3 Dec 2020to 7 Jul 2023
Phase: Phase 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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide written informed consent.
Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug.
If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study.
Able and willing to comply with all study procedures.
Female patients must be either post-menopausal for at least 1 year 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 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 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

Known hypersensitivity to any constituent of the study drug.
Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
Planned or expected vaccination with live attenuated vaccines during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
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

38 sites in 1 country.

City, postcode or hospital

38 sites in 1 country

United States38 sites

Allakos Investigational Site 216-034
Aurora, Colorado, 80045
Allakos Investigational Site 216-022
Austin, Texas, 78742
Allakos Investigational Site 216-068
Birmingham, Alabama, 35209
Allakos Investigational Site 216-026
Boston, Massachusetts, 02111
Allakos Investigational Site 216-052
Boston, Massachusetts, 02115
Allakos Investigational Site 216-051
Boston, Massachusetts, 02215
Allakos Investigational Site 216-063
Brandon, Florida, 33511
Allakos Investigational Site 216-020
Chapel Hill, North Carolina, 27599
Allakos Investigational Site 216-006
Chattanooga, Tennessee, 37343
Allakos Investigational Site 216-003
Chattanooga, Tennessee, 37404
Allakos Investigational Site 216-011
Chattanooga, Tennessee, 37421
Allakos Investigational Site 216-007
Chicago, Illinois, 60611
Allakos Investigational Site 216-032
Chula Vista, California, 91910
Allakos Investigational Site 216-031
Cincinnati, Ohio, 45229
Allakos Investigational Site 216-028
Cincinnati, Ohio, 45236
Allakos Investigational Site 216-001
Crowley, Louisiana, 70526
Allakos Investigational Site 216-048
Durham, North Carolina, 27710
Allakos Investigational Site 216-027
Edgewater, Florida, 32132
Allakos Investigational Site 216-002
Huntsville, Alabama, 35802
Allakos Investigational Site 216-056
Jacksonville, Florida, 32256
Allakos Investigational Site 216-042
Kansas City, Missouri, 64108
Allakos Investigational Site 216-062
Kingsport, Tennessee, 37663
Allakos Investigational Site 216-044
Mentor, Ohio, 44060
Allakos Investigational Site 216-013
Miami, Florida, 33176
Allakos Investigational Site 216-053
New Port Richey, Florida, 34653
Allakos Investigational Site 216-025
New York, New York, 10029
Allakos Investigational Site 216-039
Ogden, Utah, 84405
Allakos Investigational Site 216-021
Philadelphia, Pennsylvania, 19104
Allakos Investigational Site 216-035
Phoenix, Arizona, 85018
Allakos Investigational Site 216-045
Reno, Nevada, 89511
Allakos Investigational Site 216-005
Rochester, Minnesota, 55905
Allakos Investigational Site 216-030
Salt Lake City, Utah, 84132
Allakos Investigational Site 216-055
Sandy City, Utah, 84092
Allakos Investigational Site 216-014
Santa Monica, California, 90404
Allakos Investigational Site 216-064
Spokane, Washington, 99202
Allakos Investigational Site 216-038
Tustin, California, 92780
Allakos Investigational Site 216-049
Walnut Creek, California, 94598
Allakos Investigational Site 216-050
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.

Conditions: Eosinophilic Gastritis, Eosinophilic Duodenitis
Being tested: lirentelimab
Medical subject headings: Eosinophilic enteropathy

What participants receive

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

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

Study groups in NCT04620811
Study group	Role	What they receive
3.0 mg/kg of Lirentelimab (AK002)	Experimental	Subjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002) Receives: Drug: lirentelimab

What is being measured

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

The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
Adverse events assessed using the CTCAE version 5.0.
Measured: Through study completion, up to 21 months

Timeline

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

3 Dec 20207 Jul 2023

First posted9 Nov 2020
Study start3 Dec 2020
Primary completion15 May 2023
Study completion7 Jul 2023

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 GastritisStudies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04620811
Sponsor's protocol ID: AK002-016X
Status last verified: Apr 2024
First submitted: 3 Nov 2020
Last updated: 22 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: 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

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The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
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All Eosinophilic Gastritis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
ClinicalTrials.gov ID: NCT04620811
Acronym / sponsor ID: AK002-016X
Conditions: Eosinophilic Gastritis, Eosinophilic Duodenitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Allakos Inc.Industry (pharma, biotech, devices)
Study start: 3 Dec 2020 (actual)
Primary completion: 15 May 2023 (actual)
Study completion: 7 Jul 2023 (actual)
First posted: 9 Nov 2020 (actual)
Results: Posted 18 Apr 2024

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 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
3.0 mg/kg of Lirentelimab (AK002)	Experimental	Drug: lirentelimabSubjects in this arm will receive up to 18 monthly doses (3mg/kg) of lirentelimab (AK002)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provide written informed consent.
Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug.
If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study.
Able and willing to comply with all study procedures.
Female patients must be either post-menopausal for at least 1 year 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 until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.

Key exclusion criteria (5 listed)

Known hypersensitivity to any constituent of the study drug.
Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
Planned or expected vaccination with live attenuated vaccines during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
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.

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
lirentelimabAlso: AK002Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8	Drug	3.0 mg/kg of Lirentelimab (AK002)

Primary outcome

The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0
Time frame: Through study completion, up to 21 months
Adverse events assessed using the CTCAE version 5.0.

Results and safety

Results posted to the registry on 18 Apr 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
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	75	42
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	84	40

Primary outcome: The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0

Time frame: Through study completion, up to 21 months. Count of participants. Unit: Participants

Measure	Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002) n = 75	Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002) n = 84
No. of Subjects with >=1 Adverse Events	66	75
No. of Subjects with >=1 Treatment-Related Adverse Events	33	29
No. of Subjects with >=1 Serious Adverse Events	6	14
No. of Subjects with an Adverse Event Leading to Study Drug Discontinuation	6	10
No. of Subjects with >=1 Treatment-Related Serious Adverse Events	1	1

Adverse events

Time frame: Through study completion, up to 21 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	6 of 75 (8%)	52 of 75 (69.3%)	0 of 75
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)	14 of 84 (16.7%)	57 of 84 (67.9%)	1 of 84

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Eosinophilic Gastritis

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
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RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Active, not recruiting
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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 Patterson, MD study director

Allakos Inc.

38 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lirentelimab in people with Eosinophilic Gastritis and Eosinophilic Duodenitis, run by Allakos Inc. at 38 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 6 inclusion and 5 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 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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 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 18 Apr 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?

The Safety and Tolerability of Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0 (time frame: Through study completion, up to 21 months). 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 NCT04620811.

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 22 Apr 2024.