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Eosinophilic GastritisPhase 3ENIGMA 2NCT04322604

A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

A Phase 3 study testing lirentelimab (AK002) in people with Eosinophilic Gastritis and Eosinophilic Duodenitis, run by Allakos Inc. at 60 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, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
lirentelimab (AK002)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
181 participants
Where
60 sitesUnited States
Study dates
18 Jun 2020to 12 Jan 2022
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.
  • Male or female aged ≥18 and ≤80 years at the time of signing the informed consent for entry.
  • Baseline endoscopic biopsy with ≥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.
  • Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.
  • Patients with inadequate or loss of response to, or who were intolerant to standard therapies for EG/EoD symptoms, which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others.
  • If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study.
  • Willing and able to comply with all study procedures and visit schedule including follow-up visits.
  • Female patients 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 patients 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 (e.g., missed or later menstrual period) at any time during study participation.

Who cannot join

  • Use of systemic or topical corticosteroids exceeding the equivalent of 10 mg/day of prednisone within 4 weeks prior to the screening visit.
  • Change in the dose of corticosteroids (systemic or topical), PPI, leukotrienes, or diet therapy within 4 weeks prior to the screening visit.
  • Treatment with any immunosuppressive or immunomodulatory drugs that may interfere with the study within 12 weeks prior to the screening visit.
  • Prior exposure to AK002 or known hypersensitivity to any constituent of the study drug.
  • Active Helicobacter pylori infection, unless treated and confirmed to be negative prior to randomization and symptoms remain consistent.
  • History of inflammatory bowel disease, celiac disease, achalasia, or esophageal surgery.
Show all 20Show fewer
  • History of bleeding disorders and/or esophageal varices.
  • Other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA).
  • Confirmed diagnosis of Hypereosinophilic Syndrome (HES).
  • Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
  • Presence of an abnormal laboratory value considered to be clinically significant by the Investigator.
  • Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
  • 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).
  • Treatment for a clinically significant helminthic parasitic infection within 6 months of screening.
  • Positive Ova and Parasite (O\&P) test and/or seropositive for Strongyloides stercoralis.
  • 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.
  • Seropositive for HIV or hepatitis at screening, except for vaccinated patients or patients with past but resolved hepatitis, at screening.
  • Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products).
  • Known history of alcohol, drug, or other substance abuse or dependence, considered by the Investigator to be ongoing and clinically significant.
  • Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Allakos Investigational Site

    Ann Arbor, Michigan, 48109

  • 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

    Bristol, Connecticut, 06010

  • Allakos Investigational Site

    Chapel Hill, North Carolina, 27599

  • Allakos Investigational Site

    Charlotte, North Carolina, 28210

  • Allakos Investigational Site

    Chattanooga, Tennessee, 37421

  • Allakos Investigational Site

    Chevy Chase, Maryland, 20815

  • Allakos Investigational Site

    Chicago, Illinois, 60611

  • Allakos Investigational Site

    Chula Vista, California, 91910

  • Allakos Investigational Site

    Cincinnati, Ohio, 45229

  • Allakos Investigational Site

    Cincinnati, Ohio, 45231

  • Allakos Investigational Site

    Cleveland, Ohio, 44106

  • Allakos Investigational Site

    Colorado Springs, Colorado, 80907

  • 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

    Fairfax, Virginia, 22031

  • Allakos Investigational Site

    Gilbert, Arizona, 85234

  • Allakos Investigational Site

    Great Neck, New York, 11021

  • Allakos Investigational Site

    Hixson, Tennessee, 37343

  • Allakos Investigational Site

    Houston, Texas, 77070

  • Allakos Investigational Site

    Huntsville, Alabama, 38801

  • Allakos Investigational Site

    Jacksonville, Florida, 32256

  • Allakos Investigational Site

    Kansas City, Missouri, 64108

  • Allakos Investigational Site

    Kingsport, Tennessee, 37663

  • Allakos Investigational Site

    La Jolla, California, 92037

  • Allakos Investigational Site

    Las Vegas, Nevada, 89106

  • Allakos Investigational Site

    Little Rock, Arkansas, 72205

  • Allakos Investigational Site

    Mentor, Ohio, 44060

  • Allakos Investigational Site

    Miami, Florida, 33176

  • Allakos Investigational Site

    Murrieta, California, 92563

  • Allakos Investigational Site

    Nashville, Tennessee, 37212

  • Allakos Investigational Site

    New Port Richey, Florida, 34653

  • 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

    Philadelphia, Pennsylvania, 19104

  • Allakos Investigational Site

    Phoenix, Arizona, 85021

  • Allakos Investigational Site

    Reno, Nevada, 89511

  • Allakos Investigational Site

    Riverton, Utah, 84065

  • Allakos Investigational Site

    Rochester, Minnesota, 55905

  • Allakos Investigational Site

    Rocky Mount, North Carolina, 27804

  • Allakos Investigational Site

    Salt Lake City, Utah, 84132

  • Allakos Investigational Site

    Sandy City, Utah, 84092

  • Allakos Investigational Site

    Santa Monica, California, 90404

  • Allakos Investigational Site

    Scottsdale, Arizona, 85259

  • Allakos Investigational Site

    Spokane, Washington, 99202

  • Allakos Investigational Site

    Tustin, California, 92780

  • Allakos Investigational Site

    Ventura, California, 93003

  • Allakos Investigational Site

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) who have an inadequate response with, lost response to, or were intolerant to standard therapies

Being tested
lirentelimab (AK002), Placebo
Keywords
Eosinophil, Eosinophilic, Eosinophilic gastrointestinal disorders, EGID, EG, EGE, Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Duodenitis
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.

  • lirentelimab (AK002)Drug

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

  • PlaceboOther

    Placebo

Study groups in NCT04322604
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Other: Placebo
3 mg/kg of lirentelimab (AK002)ExperimentalSubjects 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.

  1. Proportion of Tissue Eosinophil Responders at Week 24

    A tissue eosinophil responder is defined as mean eosinophil count ≤4 cells/HPF in 5 gastric HPFs for EG only patients, ≤15 cells/HPF in 3 duodenal HPFs for EoD only patients, and ≤4 cells/HPF in 5 gastric HPFs and ≤15 cells/HPF in 3 duodenal HPFs for EG+EoD patients.

    Measured: At Week 24

  2. Change in PRO Total Symptom Score (TSS) From Baseline to Weeks 23-24

    The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.

    Measured: Baseline to Weeks 23 - 24

Secondary outcomes (6)

  1. Change in Tissue Eosinophils From Baseline to Week 24

    Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro-duodenoscopy (EGD)

    Measured: Baseline to Week 24

  2. Subjects Achieving Mean Eosinophil Count ≤1 Cell/Hpf in 5 Highest Gastric Hpf and/or Mean Eosinophil Count ≤1 Cell/Hpf in 3 Highest Duodenal Hpf at Week 24

    Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro-duodenoscopy (EGD)

    Measured: At Week 24

  3. Number of Treatment Responders

    Treatment responders defined by >30% improvement in TSS at Weeks 23-24 and eosinophil count ≤4 cells/hpf in 5 gastric hpf and/or eosinophil count ≤15 cells/hpf in 3 duodenal hpf at Week 24

    Measured: Weeks 23-24 and at Week 24, respectively

  4. Subjects Who Achieve ≥50% Reduction in TSS From Baseline to Weeks 23-24

    The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.

    Measured: At Weeks 23-24

  5. Subjects Who Achieve ≥70% Reduction in TSS From Baseline to Weeks 23-24

    The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.

    Measured: At Weeks 23-24

  6. Percent Change in Weekly TSS Over Time Using MMRM

    The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.

    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.

  1. First posted26 Mar 2020
  2. Study start18 Jun 2020
  3. Primary completion29 Nov 2021
  4. Study completion12 Jan 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04322604
Sponsor's protocol ID
AK002-016
Acronym
ENIGMA 2
Status last verified
Dec 2023
First submitted
24 Mar 2020
Last updated
2 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lirentelimab (AK002) in people with Eosinophilic Gastritis and Eosinophilic Duodenitis, run by Allakos Inc. at 60 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 8 inclusion and 20 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 60 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. 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 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 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 Tissue Eosinophil Responders 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 NCT04322604.

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; AzTrials last refreshed its copy on 7 Nov 2026.

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