Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04322604 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
A Phase 3 study, sponsored by Allakos.
- Completed
- Registry status
- Phase 3
- Development phase
- 181
- Enrollment target
NCT04322604: Completed Phase 3 study, sponsored by Allakos.
NCT04322604 is a Phase 3 study that has completed, run by Allakos. The registered enrollment target is 181 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04322604, a Phase 3 study, has completed, sponsored by Allakos.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 181 participants
- Enrollment target
Study Summary
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) who have an inadequate response with, lost response to, or were intolerant to standard therapies
Primary Outcome
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.
Interventions
- OTHER Placebo
- DRUG lirentelimab (AK002)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2020-06-18 |
| Est. Completion | 2022-01-12 |
| Phase | Phase 3 |
What the finished NCT04322604 record still lists
NCT04322604 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04322604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04322604 about?
NCT04322604 is a clinical study titled "A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)". This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosi...
What is the current status of trial NCT04322604?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 181 participants. The study started on 2020-06-18. Estimated completion is 2022-01-12.
What interventions are being tested in trial NCT04322604?
The interventions under investigation include: Placebo (OTHER), lirentelimab (AK002) (DRUG).
Who is sponsoring clinical trial NCT04322604?
This trial is sponsored by Allakos, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04322604's enrollment target sits among peer trials
181 1422nd of 2000 higher than 579 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04578392 · 181 participants · NA
MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
- NCT05597891 · 181 participants · NA
Endovascular Engineering ENGULF Study
- NCT03897998 · 182 participants · Phase 2
Neural Correlates of Hypoalgesia Driven by Observation
- NCT04300556 · 182 participants · Phase 1
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI