Adults 18 to 80, any sex, with Eosinophilic Gastritis or Eosinophilic Duodenitis. 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 Lirentelimab by Evaluating Adverse Events Assessed Using the CTCAE Version 5.0Primary· Through study completion, up to 21 months
Adverse events assessed using the CTCAE version 5.0.
No. of Subjects with >=1 Adverse Events
Group
Value
95% CI
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
66
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
75
No. of Subjects with >=1 Treatment-Related Adverse Events
Group
Value
95% CI
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
33
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
29
No. of Subjects with >=1 Serious Adverse Events
Group
Value
95% CI
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
6
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
14
No. of Subjects with an Adverse Event Leading to Study Drug Discontinuation
Group
Value
95% CI
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
6
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
10
No. of Subjects with >=1 Treatment-Related Serious Adverse Events
Group
Value
95% CI
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
1
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
1
Proportion of Tissue Eosinophil RespondersSecondary· At Follow-up EGD (Esophago-Gastro-Duodenoscopy) (Day 505 or 28 days after last dose if ET)
A tissue eosinophil responder is defined as mean eosinophil count ≤4 cells/HPF in 5 gastric HPFs for EG only patients, ≤15 cells/HPF in 3 duodenal HPFs for EoD only patients, and ≤4 cells/HPF in 5 gastric HPFs and ≤15 cells/HPF in 3 duodenal HPFs for EG+EoD patients.
Group
Value
95% CI
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
52
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
48
Change in PRO Total System Score (TSS) From AK002-016/AK002-012 BaselineSecondary· Main Study Baseline to Extension Weeks 71-72
The PRO Total Symptom Score (TSS) is a patient reported outcome (PRO) questionnaire comprises the following 6 symptoms: Abdominal pain intensity, Nausea intensity, Fullness before meal intensity, Loss of appetite intensity, Bloating intensity, and Abdominal cramping intensity. TSS scores can range from 0 to 60, with a lower score indicating less-severe symptoms.
Group
Value
95% CI
Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
-14.4
± 11.0
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
-17.0
± 12.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Through study completion, up to 21 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 3.0 mg/kg of Lirentelimab (AK002)
Serious: 6/75 (8%)
Deaths: 0/75
Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002)
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: 22 April 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/NCT04620811.