At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 58 enrolled
Drug / intervention
AK002drug
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 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
In Brief
A Phase 2 clinical trial evaluating AK002 for Eosinophilic Gastritis and 2 related conditions. Completed, enrolled 58 participants across 17 sites.
Detailed Summary
This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartNov 2018
Primary CompletionNov 2021
TodayJul 2026
First PostedSep 11, 2018
Enrollment StartNov 14, 2018
Primary CompletionNov 2, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.8 years ago
Interventions
AK002drug
AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.