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Monoclonal Antibodies

AK002 for Eosinophilic Gastritis (ENIGMA-SC Trial)

Phase 3
Waitlist Available
Research Sponsored by Allakos Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new injection treatment called lirentelimab (AK002) for people with severe stomach and intestinal inflammation who haven't had success with other treatments. The medication aims to reduce inflammation by calming down certain white blood cells. Patients will receive the injection regularly over several months.

Eligible Conditions
  • Eosinophilic Gastritis
  • Eosinophilic Duodenitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Responders as determined by gastric or duodenal tissue eosinophil counts.

Side effects data

From 2023 Phase 3 trial • 94 Patients • NCT04856891
20%
Infusion related reaction
11%
Corona virus infection
9%
Sinusitis
7%
Abdominal pain
4%
Hiatus hernia
2%
Headache
2%
Diabetic ketoacidosis
2%
Diarrhea
2%
Depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
3.0 mg/kg of Lirentelimab (AK002)
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: SC 450 mg of lirentelimab (AK002)Experimental Treatment1 Intervention
Subjects in this arm will receive 6 monthly doses of 450 mg of lirentelimab (AK002) administered subcutaneously.
Group II: SC 300 mg of lirentelimab (AK002)Experimental Treatment1 Intervention
Subjects in this arm will receive 6 monthly doses of 300 mg of lirentelimab (AK002) administered subcutaneously.
Group III: SC 150 mg of lirentelimab (AK002)Experimental Treatment1 Intervention
Subjects in this arm will receive 6 monthly doses of 150 mg of lirentelimab (AK002) administered subcutaneously.
Group IV: PlaceboExperimental Treatment1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AK002
2016
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

Allakos Inc.Lead Sponsor
17 Previous Clinical Trials
1,593 Total Patients Enrolled
4 Trials studying Eosinophilic Gastritis
463 Patients Enrolled for Eosinophilic Gastritis
Allakos, Inc.Lead Sponsor
14 Previous Clinical Trials
1,258 Total Patients Enrolled
4 Trials studying Eosinophilic Gastritis
463 Patients Enrolled for Eosinophilic Gastritis
Craig Paterson, MDStudy DirectorAllakos Inc.
6 Previous Clinical Trials
868 Total Patients Enrolled
2 Trials studying Eosinophilic Gastritis
239 Patients Enrolled for Eosinophilic Gastritis
~0 spots leftby Nov 2025
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