Eosinophilic GastritisPhase 2NCT03664960
An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
A Phase 2 study testing AK002 in people with Eosinophilic Gastritis and Eosinophilic Gastroenteritis, run by Allakos Inc. at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Duodenitis
- What is being tested?
- AK002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 17 sitesUnited States
- Study dates
- 14 Nov 2018to 2 Nov 2021
- Phase
- Phase 2
- 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 AK002-003, 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 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
- Poor tolerance to previous administration of AK002 in the opinion of the Investigator.
- 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.
- 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. 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).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Avant Research Associates
Austin, Texas, 78704
NIH
Bethesda, Maryland, 20892
Tufts Medical Center
Boston, Massachusetts, 02111
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
ClinSearch
Chattanooga, Tennessee, 37421
Northwestern
Chicago, Illinois, 60611
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
University of Iowa
Iowa City, Iowa, 52242
Vanderbilt University
Nashville, Tennessee, 37212
Advanced Research Institute
New Port Richey, Florida, 34653
Mount Sinai
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Phoenician Centers for Research and Innovation
Phoenix, Arizona, 85021
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84132
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Ventura Clinical Trials
Ventura, California, 93003
About this study
Official title: A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.
- Being tested
- AK002
- Keywords
- Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophil, EG, EGE, EGID, Eosinophilic gastrointestinal disorders, Eosinophilic Duodenitis, EoD
- Medical subject headings
- Eosinophilic enteropathy, Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK002Drug
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
| Study group | Role | What they receive |
|---|---|---|
| 1 to 3.0 mg/kg of AK002 | Experimental | 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 Receives: Drug: AK002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, up to 28 months
Secondary outcomes (2)
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.
Measured: 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
Measured: AK002-003 Baseline to Day 547
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start14 Nov 2018
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allakos Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Paterson, MD, Study director, Allakos Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664960
- Sponsor's protocol ID
- AK002-003X
- Status last verified
- Feb 2024
- First submitted
- 6 Sep 2018
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
- ClinicalTrials.gov ID
- NCT03664960
- Acronym / sponsor ID
- AK002-003X
- Keywords
- Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophil, EG, EGE, EGID, Eosinophilic gastrointestinal disorders, Eosinophilic Duodenitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Allakos Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Posted 28 Feb 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 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 to 3.0 mg/kg of AK002 | Experimental | Drug: AK002Subjects 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 |
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 AK002-003, 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 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 (7 listed)
- Poor tolerance to previous administration of AK002 in the opinion of the Investigator.
- 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.
- 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. 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.
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 |
|---|---|---|
| AK002AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. | Drug | 1 to 3.0 mg/kg of AK002 |
Primary outcome
The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03
Time frame: Through study completion, up to 28 months
Adverse events assessed using the CTCAE version 4.03
2 secondary outcomes
Percent Change in PRO Total Symptom Score (TSS) From AK002-003 Baseline
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
Time frame: AK002-003 Baseline to Day 547
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Eosinophilic Gastritis
Active, not recruitingPhase 2
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RecruitingObservational study
Study of Gastric Motility in Eosinophilic Gastritis
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OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
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National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK002 in people with Eosinophilic Gastritis and Eosinophilic Gastroenteritis, run by Allakos Inc. at 17 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 7 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Feb 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 AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03 (time frame: Through study completion, up to 28 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.