Adults 18 to 80, any sex, with Eosinophilic Gastritis or Eosinophilic Gastroenteritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change in the Number of Eosinophils Per High Power Field in Gastric or Duodenal Mucosa From BaselinePrimary· Baseline to Day 99
Tissue eosinophil count obtained in biopsy specimens from the stomach and/or duodenum using esophago-gastro- duodenoscopy (EGD)
Group
Value
95% CI
1 mg/kg of AK002
-79
-95 – -59
3 mg/kg of AK002
-92
-100 – -81
Combined AK002
-86
-94 – -71
Placebo
9
-15 – 31
Number of Treatment RespondersSecondary· On Days 85-99 and Day 99, respectively
Treatment Responders defined by \>30% improvement in TSS and a reduction of \>75% in eosinophils in gastric and/or duodenal mucosa. The eosinophil count is obtained on Day 99 and the TSS score is the average of the daily scores from Days 85-99.
Group
Value
95% CI
1 mg/kg of AK002
13
3 mg/kg of AK002
14
Combined AK002
27
Placebo
1
Percent Change in PRO Total Symptom Score (TSS) From BaselineSecondary· Baseline to Days 85-99
The PRO Total Symptom Score (TSS) is a patient-reported outcome (PRO) questionnaire comprises the following 8 symptoms: abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Individual symptom scores ranged from 0 to 10. The daily total symptom score ranged from 0 to 80, with higher scores indicating greater severity. TSS score at the End of Study is the average of the daily scores from Days 85-99.
Group
Value
95% CI
1 mg/kg of AK002
-42
-56 – -28
3 mg/kg of AK002
-55
-70 – -40
Combined AK002
-48
-58 – -39
Placebo
-22
-37 – -7
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to Day 113.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05155085 — A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
· Phase 2
· terminated
NCT04856891 — A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
· Phase 3
· completed
NCT03664960 — An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
· Phase 2
· completed
NCT03379311 — A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conju
· Phase 1
· completed
NCT03436797 — A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria
· Phase 2
· completed
Other recruiting trials for Eosinophilic Gastritis
Currently open trials in the same condition.
NCT05229432 — Study of Gastric Motility in Eosinophilic Gastritis
· recruiting
NCT02523118 — OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
· recruiting
Other Allakos Inc. trials
Trials by the same sponsor.
NCT06577116 — Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study
· Phase 1
· completed
NCT06072157 — Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of AK006 in Healthy Subjects and Subjects
· Phase 1
· completed
NCT05528861 — A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria
· Phase 2
· terminated
NCT05155085 — A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
· Phase 2
· terminated
NCT04856891 — A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allakos Inc.
Last refreshed: 19 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03496571.