At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 159 enrolled
Drug / intervention
lirentelimabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
In Brief
A Phase 3 clinical trial evaluating lirentelimab for Eosinophilic Gastritis and Eosinophilic Duodenitis. Completed, enrolled 159 participants across 38 sites.
Detailed Summary
This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Gastritis, Eosinophilic Duodenitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartDec 2020
Primary CompletionMay 2023
Study CompletionJul 2023
TodayJul 2026
First PostedNov 9, 2020
Enrollment StartDec 3, 2020
Primary CompletionMay 15, 2023
Study CompletionJul 7, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.6 years ago
Interventions
lirentelimabdrug
Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8