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.
The Safety and Tolerability of AK002 by Evaluating Adverse Events Assessed Using the CTCAE Version 4.03Primary· Through study completion, up to 28 months
Adverse events assessed using the CTCAE version 4.03
Subjects with ≥1 adverse events
Group
Value
95% CI
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
21
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
35
Subjects with ≥1 treatment-related adverse events
Group
Value
95% CI
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
15
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
22
Subjects with an adverse event leading to study discontinuation
Group
Value
95% CI
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
0
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
3
Subjects with ≥1 serious adverse events
Group
Value
95% CI
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
2
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
9
Subjects with ≥1 treatment-related serious adverse events
Group
Value
95% CI
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
0
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
0
Percent Change in PRO Total Symptom Score (TSS) From AK002-003 BaselineSecondary· AK002-003 Baseline to End of Treatment (2 weeks post last dose, up to 26 months)
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. The End of treatment TSS score is defined as the average of the 14 daily scores on or after the day of the last dose of the extension study.
Group
Value
95% CI
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
-66.3
± 27.7
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
-60.6
± 32.4
Changes in the Number of Eosinophils in Gastric and/or Duodenal Mucosa From AK002-003 BaselineSecondary· AK002-003 Baseline to Day 547
Percentage of Change in the Number of Eosinophils in Gastric and/or Duodenal Mucosa in each group from AK002-003 Baseline
Group
Value
95% CI
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
-93.5
± 18.9
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
-99.7
± 0.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Through study completion, up to 28 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002
Serious: 2/21 (10%)
Deaths: 0/21
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002
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
NCT03496571 — A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis
· 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: 28 February 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/NCT03664960.