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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
Provide written informed consent.
Male or female aged ≥18 and ≤80 years at the time of signing the informed consent for entry.
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
1,524 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research projects which have used AK002?

"Currently, there are 3 ongoing clinical trials assessing AK002. 2 of these studies have reached Phase 3 while the remaining is still in an earlier stage. Although a few of the clinical trials evaluating AK002 are situated in Austin, Texas, there are a total of 181 research centres conducting investigations into AK002 across the globe."

Answered by AI

Does age limit one's ability to participate in this research project?

"According to the requirements for this study, anyone over 18 and under 80 years old may be enrolled."

Answered by AI

Who would be an eligible candidate to join this particular clinical trial?

"This trial is seeking 280 individuals with duodenitis that are between 18 and 80 years old. Most notably, patients must meet the following criteria: 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, anti"

Answered by AI

Is this a new experimental procedure?

"The development of AK002 began in 2020 with the first clinical trials. 170 patients participated in this initial study which was sponsored by Allakos Inc.. After the successful Phase 1 and 2 trials, AK002 received drug approval for Phase 3 clinical trials. Currently, there are active studies involving AK002 across 104 cities and 1 countries."

Answered by AI

Are there any clinical trials similar to this one being conducted in Canada?

"enrollees should try to pick a site close to them from the 71 presently recruiting patients. To name a few, these sites are located in Fort Worth, Wyoming and Bay Saint Louis among other places. Reducing travel is important for those who enroll."

Answered by AI

What is the total number of participants involved in this research project?

"That is correct, the information displayed on clinicaltrials.gov indicates that this study requires more participants. The trial was originally posted on December 1st 2021 and was last updated 9 days ago. In total, they are looking for 280 people to fill the vacant positions at 71 different locations."

Answered by AI

What is the estimated mortality rate for patients with AK002?

"Data from prior clinical trials and patient safety reports support the use of AK002, giving it a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis
2021. "A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05152563.
~0 spots leftby Apr 2025
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