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Eosinophilic GastritisPhase 3ENIGMA-SCNCT05152563

A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis

A Phase 3 study testing AK002 in people with Eosinophilic Gastritis and Eosinophilic Duodenitis, run by Allakos Inc. at 76 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacodynamic effect of subcutaneous lirentelimab (AK002), given monthly for 6 doses, in subjects with moderate to severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis who… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
AK002
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
76 sitesUnited States
Study dates
Dec 2021to 20 Jan 2022
Phase
Phase 3
Are there results?
None posted in the registry

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 at least 5 hpf in the stomach and/or ≥30 eosinophils/hpf in at least 3 hpf in the duodenum as determined by central histology assessment of biopsies collected during the screening EGD without any other significant cause for the eosinophilia.
  • Completion of at least 4 daily PRO questionnaires per week for a minimum of 3 weeks during screening.
  • A weekly average score of abdominal pain, nausea, or diarrhea ≥3 on the PRO questionnaire (score from 0-10) and a weekly average TSS of ≥10 for at least 2 weeks of screening.
  • Subjects with inadequate or loss of response to, or who were intolerant to standard therapies for EG and/or EoD, which could include PPI, antihistamines, systemic or topical corticosteroids, and/or diet, among others.
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  • If subject is on preexisting 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 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 (e.g., missed or late 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 Heliobacter pylori (H. pylori) infection as confirmed by stool antigen test for H. pylori or identified in tissue biopsies obtained at screening EGD.
  • History of inflammatory bowel disease, celiac disease, achalasia, or esophageal surgery.
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  • History of bleeding disorders and/or esophageal varices considered to be clinically significant by the Investigator.
  • Other significant 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 subject at increased risk.
  • History of malignancy, except carcinoma in situ, early-stage prostate cancer, or non-melanoma skin cancers. However, subjects with cancers that have been in remission for more than 5 years and are considered cured can be enrolled.
  • Treatment for a clinically significant helminthic parasitic infection within 6 months of screening.
  • Positive helminthic infection on Ova and Parasite (O\&P) test.
  • Seropositive for Strongyloides stercoralis at screening.
  • Seropositive for HIV or hepatitis at screening except for vaccinated subjects or subjects with past but resolved hepatitis at screening.
  • Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study or expected during the treatment period. Vaccines authorized by FDA or other regulatory authority for the prevention of COVID-19 may be administered before, during, or after this protocol as per the label. The vaccine should not be administered within 7 days prior to and within 7 days after the administration of AK002 so that the side effects caused by either of the 2 medications can be more easily determined.
  • 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 that is 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 subject unsuitable for enrollment.

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • Allakos Investigational Site

    Ann Arbor, Michigan, 48104

  • Allakos Investigational Site

    Atlanta, Georgia, 30342

  • Allakos Investigational Site

    Austin, Texas, 78757

  • Allakos Investigational Site

    Bay Saint Louis, Mississippi, 63106

  • Allakos Investigational Site

    Birmingham, Alabama, 35205

  • Allakos Investigational Site

    Boston, Massachusetts, 02111

  • 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, 28204

  • Allakos Investigational Site

    Chattanooga, Tennessee, 37421

  • Allakos Investigational Site

    Chicago, Illinois, 60611

  • Allakos Investigational Site

    Chula Vista, California, 91910

  • Allakos Investigational Site

    Cincinnati, Ohio, 45229

  • Allakos Investigational Site

    Columbus, Ohio, 43210

  • Allakos Investigational Site

    Concord, North Carolina, 28027

  • Allakos Investigational Site

    Crowley, Louisiana, 70526

  • Allakos Investigational Site

    Dayton, Ohio, 45415

  • Allakos Investigational Site

    Durham, North Carolina, 27710

  • Allakos Investigational Site

    Edgewater, Florida, 32132

  • Allakos Investigational Site

    El Paso, Texas, 79905

  • Allakos Investigational Site

    Fairfax, Virginia, 22031

  • Allakos Investigational Site

    Florham Park, New Jersey, 07932

  • Allakos Investigational Site

    Flowood, Mississippi, 39232

  • Allakos Investigational Site

    Fort Worth, Texas, 76104

  • Allakos Investigational Site

    Freehold, New Jersey, 07728

  • Allakos Investigational Site

    Germantown, Tennessee, 38138

  • Allakos Investigational Site

    Gilbert, Arizona, 85234

  • Allakos Investigational Site

    Glen Burnie, Maryland, 21061

  • Allakos Investigational Site

    Great Neck, New York, 11023

  • Allakos Investigational Site

    Greenwood, South Carolina, 29646

  • Allakos Investigational Site

    Hixson, Tennessee, 37343

  • Allakos Investigational Site

    Iowa City, Iowa, 52242

  • Allakos Investigational Site

    Jacksonville, Florida, 32256

  • Allakos Investigational Site

    Kalispell, Montana, 59901

  • Allakos Investigational Site

    Kansas City, Kansas, 66160

  • Allakos Investigational Site

    Kansas City, Missouri, 64108

  • Allakos Investigational Site

    Kissimmee, Florida, 34741

  • Allakos Investigational Site

    Lebanon, New Hampshire, 03756

  • Allakos Investigational Site

    Long Beach, California, 90808

  • Allakos Investigational Site

    Lubbock, Texas, 79410

  • Allakos Investigational Site

    Mentor, Ohio, 44060

  • Allakos Investigational Site

    Miami, Florida, 33125

  • 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

    Ogden, Utah, 84405

  • Allakos Investigational Site

    Oklahoma City, Oklahoma, 73102

  • Allakos Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Allakos Investigational Site

    Phoenix, Arizona, 85021

  • Allakos Investigational Site

    Ponte Vedra, Florida, 32081

  • Allakos Investigational Site

    Raleigh, North Carolina, 27607

  • Allakos Investigational Site

    Reno, Nevada, 89511

  • Allakos Investigational Site

    Riverton, Utah, 84065

  • Allakos Investigational Site

    Rochester, Minnesota, 55905

  • Allakos Investigational Site

    Salt Lake City, Utah, 84112

  • Allakos Investigational Site

    San Antonio, Texas, 78229

  • Allakos Investigational Site

    Sandy City, Utah, 84092

  • Allakos Investigational Site

    Sandy Springs, Georgia, 30328

  • Allakos Investigational Site

    Scottsdale, Arizona, 85250

  • Allakos Investigational Site

    Seattle, Washington, 98115

  • Allakos Investigational Site

    Seattle, Washington, 98122

  • Allakos Investigational Site

    Shreveport, Louisiana, 71105

  • Allakos Investigational Site

    Southlake, Texas, 76092

  • Allakos Investigational Site

    Springboro, Ohio, 45066

  • Allakos Investigational Site

    Sunrise, Florida, 33351

  • Allakos Investigational Site

    Tampa, Florida, 33603

  • Allakos Investigational Site

    Tampa, Florida, 33612

  • Allakos Investigational Site

    Ventura, California, 93003

  • Allakos Investigational Site

    Walnut Creek, California, 94598

  • Allakos Investigational Site

    Webster, Texas, 77598

  • Allakos Investigational Site

    Westlake, Ohio, 44145

  • Allakos Investigational Site

    Wichita Falls, Texas, 76301

  • Allakos Investigational Site

    Winston-Salem, North Carolina, 27157

  • Allakos Investigational Site

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of Subcutaneous AK002 in Subjects With Moderate to Severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacodynamic effect of subcutaneous lirentelimab (AK002), given monthly for 6 doses, in subjects with moderate to severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis who have an inadequate response with, lost response to, or were intolerant to standard therapies.

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

    Also called Lirentelimab

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

  • PlaceboOther

    Placebo

Study groups in NCT05152563
Study groupRoleWhat they receive
SC 150 mg of lirentelimab (AK002)ExperimentalSubjects in this arm will receive 6 monthly doses of 150 mg of lirentelimab (AK002) administered subcutaneously.
Receives: Drug: AK002
SC 300 mg of lirentelimab (AK002)ExperimentalSubjects in this arm will receive 6 monthly doses of 300 mg of lirentelimab (AK002) administered subcutaneously.
Receives: Drug: AK002
SC 450 mg of lirentelimab (AK002)ExperimentalSubjects in this arm will receive 6 monthly doses of 450 mg of lirentelimab (AK002) administered subcutaneously.
Receives: Drug: AK002
PlaceboOtherPlacebo
Receives: Other: Placebo

What is being measured

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

  1. Proportion of Responders as determined by gastric or duodenal tissue eosinophil counts.

    A responder is a subject achieving the following peak eosinophil counts: eosinophil count ≤4 cells per hpf in 5 gastric hpf and/or eosinophil count ≤15 cells per hpf in 3 duodenal hpf

    Measured: At Week 24

  2. Mean absolute change in 6 symptom total symptom score (TSS: abdominal pain, nausea, abdominal cramping, loss of appetite, fullness before finishing a meal, and bloating ) as measured by the PRO questionnaire (score from 0 none - 10 worst)

    Measured: Baseline to Weeks 23 - 24

Secondary outcomes (6)

  1. Percent change in tissue eosinophils

    Measured: Baseline to Week 24

  2. Number of treatment responders as defined by >30% improvement in symptoms and mean eosinophil count ≤4 cells/hpf in 5 gastric hpf and/or mean eosinophil count ≤15 cells/hpf in 3 duodenal hpf.

    Measured: Baseline to Weeks 23-24 and at Week 24, respectively.

  3. Proportion of subjects achieving mean eosinophil count ≤1 cell/hpf in 5 highest gastric hpf and mean eosinophil count ≤1 cell/hpf in 3 highest duodenal hpf

    Measured: At Week 24

  4. Proportion of subjects who show ≥50% reduction in TSS

    Measured: Baseline to Weeks 23-24

  5. Proportion of subjects who show ≥70% reduction in TSS

    Measured: Baseline to Weeks 23-24

  6. Change in weekly TSS over time

    Measured: Baseline to Weeks 23-24

Timeline

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

  1. First posted10 Dec 2021
  2. Study startDec 2021 (estimated)
  3. Primary completion20 Jan 2022
  4. Study completion20 Jan 2022

Why it stopped: Company decision

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05152563
Sponsor's protocol ID
AK002-023
Acronym
ENIGMA-SC
Status last verified
Mar 2023
First submitted
29 Nov 2021
Last updated
3 Mar 2023
Results posted
No
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 AK002 in people with Eosinophilic Gastritis and Eosinophilic Duodenitis, run by Allakos Inc. at 76 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 9 inclusion and 21 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: withdrawn, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 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?

The study was withdrawn before enrolling participants, so there are no results.

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 Responders as determined by gastric or duodenal tissue eosinophil counts. (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 NCT05152563.

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 3 Mar 2023.

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