CompletedNCT03664960Updated Feb 28, 2024Results posted

An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis

A Phase 2 interventional study of AK002 in Eosinophilic Gastritis, Eosinophilic Gastroenteritis and Eosinophilic Duodenitis, sponsored by Allakos Inc.. Completed at 17 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Allakos Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 58
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study summary

This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.

Conditions studied

Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophilic Duodenitis

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Keywords

Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophil
EG
EGE
EGID
Eosinophilic gastrointestinal disorders
Eosinophilic Duodenitis
EoD

In context

Eosinophilic enteropathy

28 studies on the registry are indexed under Eosinophilic enteropathy; 5 are open to participants now.

This study's enrollment of 58 is above the median of 36 across 16 interventional studies indexed under Eosinophilic enteropathy.

Browse Eosinophilic enteropathy studies →

Lead sponsor

Allakos Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Provide written .
Completed Study AK002-003, defined as having received 4 infusions of study drug and followed through Day 113 (±3 days) in Study AK002-003 or discontinued from treatment due to high eosinophil counts prior to infusions 2, 3, or 4 and willing to begin extended dosing on or about Day 113 (for AK002-003 completers) or within 6 months of last dosing for patients discontinued from treatment.
If patient is on pre-existing dietary restrictions, willingness to note any changes that occur from the Baseline diet, throughout the study.
Able and willing to comply with all study procedures.
Female patients must be either for at least 1 year or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of , have a negative pregnancy test and agree to use dual methods of , 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.

Exclusion criteria

Exclusion Criteria:

Poor tolerance to previous administration of AK002 in the opinion of the Investigator.
Known 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.
Vaccination with 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. All types and formulations of vaccines (including live attenuated vaccines) authorized by FDA or other regulatory authority for the prevention of COVID-19 may be administered before, during, or after this study. The vaccine should not be administered within 7 days prior to and within 7 days after the administration of AK002 so that any side effects caused by either of the 2 medications can be more easily determined.
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.
Diagnosis of Hypereosinophilic Syndrome (HES), based on standard criteria (blood eosinophils >1500/µL with involvement of either the heart, nervous system, and/or bone marrow).

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 58 participants (actual)

Study arms

Experimental
1 to 3.0 mg/kg of AK002
Subjects in this arm will receive 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg
Drug: AK002

Interventions

DrugAK002
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.

What researchers measure

Primary outcomes

The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
Adverse events assessed using the CTCAE version 4.03
Time frame: Through study completion, up to 28 months

Secondary outcomes

Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline
The PRO Total Symptom Score (TSS) is a patient-reported outcome (PRO) questionnaire comprises the following 8 symptoms: abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Individual symptom scores ranged from 0 to 10. The daily total symptom score ranged from 0 to 80, with higher scores indicating greater severity. The End of treatment TSS score is defined as the average of the 14 daily scores on or after the day of the last dose of the extension study.
Time frame: AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months)
Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline
Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline
Time frame: AK002-003 Baseline to Day 547

Results

Posted Feb 28, 2024

Participant flow

The participants who were enrolled in and completed the study NCT03496571 had the option to participate in this open-label extension study.

Participant flow — Overall Study
Milestone	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
Started	21	37
Completed	12	15
Not completed	9	22
Withdrew: Adverse event	0	3
Withdrew: Lost to follow-up	3	2
Withdrew: Physician decision	1	0
Withdrew: Withdrawal by subject	3	14
Withdrew: Sponsor decision	1	1
Withdrew: Other	1	2

Outcome measures

PrimaryThe Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03

Adverse events assessed using the CTCAE version 4.03

Time frame:: Through study completion, up to 28 months
Reported as:: Count of participants · Participants

The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
Participants	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
Subjects with ≥1 adverse events	21	35
Subjects with ≥1 treatment-related adverse events	15	22
Subjects with an adverse event leading to study discontinuation	0	3
Subjects with ≥1 serious adverse events	2	9
Subjects with ≥1 treatment-related serious adverse events	0	0

SecondaryPercent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline

The PRO Total Symptom Score (TSS) is a patient-reported outcome (PRO) questionnaire comprises the following 8 symptoms: abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Individual symptom scores ranged from 0 to 10. The daily total symptom score ranged from 0 to 80, with higher scores indicating greater severity. The End of treatment TSS score is defined as the average of the 14 daily scores on or after the day of the last dose of the extension study.

Time frame:: AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months)
Reported as:: Mean · Percentage of change

Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline
Percentage of change	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline	-66.3 ± 27.7	-60.6 ± 32.4

SecondaryChanges in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline

Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline

Time frame:: AK002-003 Baseline to Day 547
Reported as:: Mean · Percentage of change

Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline
Percentage of change	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 Baseline	-93.5 ± 18.9	-99.7 ± 0.7

Adverse events

Collected over Through study completion, up to 28 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	0/21 (0%)	2/21 (9.5%)	20/21 (95.2%)
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002	0/37 (0%)	9/37 (24.3%)	32/37 (86.5%)

Most frequent serious events

Showing 10 of 13

Most frequent serious events
Event	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
VomitingGastrointestinal disorders	1/21	0/37
NauseaGastrointestinal disorders	1/21	0/37
Abdominal hierniaGastrointestinal disorders	1/21	0/37
Small intestinal obstructionGastrointestinal disorders	0/21	1/37
InfluenzaInfections and infestations	0/21	1/37
SpondylolisthesisMusculoskeletal and connective tissue disorders	0/21	1/37
AngioedemaSkin and subcutaneous tissue disorders	0/21	1/37
HypertensionVascular disorders	0/21	1/37
Coronary artery diseaseCardiac disorders	0/21	1/37
Abdominal painGastrointestinal disorders	0/21	1/37

Most frequent other events

Showing 10 of 38

Most frequent other events
Event	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
Infusion related reactionInjury, poisoning and procedural complications	9/21	11/37
NasopharyngitisInfections and infestations	5/21	5/37
DiarrheaGastrointestinal disorders	4/21	4/37
NauseaGastrointestinal disorders	4/21	5/37
HeadacheNervous system disorders	3/21	7/37
NeutrophiliaBlood and lymphatic system disorders	3/21	1/37
Abdominal painGastrointestinal disorders	3/21	2/37
DyspepsiaGastrointestinal disorders	3/21	0/37
VomitingGastrointestinal disorders	3/21	3/37
Injection site painGeneral disorders	3/21	1/37

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002	Total
Median	35 (18 to 67)	43 (18 to 74)	40 (18 to 74)

Sex: Female, Male
Sex: Female, Male(Participants)	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002	Total
Female	9	26	35
Male	12	11	23

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002	Total
Hispanic or Latino	0	5	5
Not Hispanic or Latino	21	32	53
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002	Total
American Indian or Alaska Native	0	1	1
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	3	3
White	21	33	54
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002	Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002	Total
United States	21	37	58

Study locations

17 sites

Phoenician Centers for Research and Innovation
Phoenix, Arizona 85021, United States
Mayo Clinic Arizona
Scottsdale, Arizona 85259, United States
Ventura Clinical Trials
Ventura, California 93003, United States
Advanced Research Institute
New Port Richey, Florida 34653, United States
Northwestern
Chicago, Illinois 60611, United States
University of Iowa
Iowa City, Iowa 52242, United States
NIH
Bethesda, Maryland 20892, United States
Tufts Medical Center
Boston, Massachusetts 02111, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
Mount Sinai
New York, New York 10029, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina 27599, United States
Cincinnati Children's Hospital
Cincinnati, Ohio 45229, United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
ClinSearch
Chattanooga, Tennessee 37421, United States
Vanderbilt University
Nashville, Tennessee 37212, United States
Avant Research Associates
Austin, Texas 78704, United States
University of Utah
Salt Lake City, Utah 84132, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Oct 18, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2018 to primary completion in Nov 2021, 35 months.

Results were first posted in Feb 2024, 2 years 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 6, 2018
First posted: Sep 11, 2018
StartActual: Nov 14, 2018
Primary completionActual: Nov 2, 2021
CompletionActual: Nov 2, 2021
Results first posted: Feb 28, 2024
Last update: Feb 28, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03664960
Lead sponsor: Allakos Inc.
Responsible party: Sponsor
First posted: Sep 11, 2018
Start date: Nov 14, 2018
Primary completion: Nov 2, 2021
Completion: Nov 2, 2021
Results posted: Feb 28, 2024
Last update: Feb 28, 2024

Study contacts

Craig Paterson, MD

study director · Allakos Inc.

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: AK002

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Allakos Inc.

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