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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 baseline to weeks 23-24 and at week 24, respectively.
Awards & highlights

ENIGMA-SC Trial Summary

This trial will test if the drug lirentelimab is effective in treating eosinophilic gastritis and/or duodenitis in patients who have not responded to other treatments.

Eligible Conditions
  • Eosinophilic Gastritis
  • Eosinophilic Duodenitis

ENIGMA-SC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 23-24 and at week 24, respectively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 23-24 and at week 24, respectively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Proportion of Responders as determined by gastric or duodenal tissue eosinophil counts.
Secondary outcome measures
Change in weekly TSS over time
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.
Percent change in tissue eosinophils
+3 more

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%
Diabetic ketoacidosis
2%
Diarrhea
2%
Depression
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
3.0 mg/kg of Lirentelimab (AK002)
Placebo

ENIGMA-SC 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
16 Previous Clinical Trials
1,532 Total Patients Enrolled
4 Trials studying Eosinophilic Gastritis
463 Patients Enrolled for Eosinophilic Gastritis
Allakos, Inc.Lead Sponsor
14 Previous Clinical Trials
1,257 Total Patients Enrolled
4 Trials studying Eosinophilic Gastritis
463 Patients Enrolled for Eosinophilic Gastritis
Craig Paterson, MDStudy DirectorAllakos Inc.
6 Previous Clinical Trials
867 Total Patients Enrolled
2 Trials studying Eosinophilic Gastritis
239 Patients Enrolled for Eosinophilic Gastritis
~0 spots leftby Jun 2025
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