drugset / Trial / NCT05152563
A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacodynamic effect of subcutaneous lirentelimab (AK002), given monthly for 6 doses, in subjects with moderate to severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis who have an inadequate response with, lost response to, or were intolerant to standard therapies.
Timeline
- Start
- 2021-12
- Primary completion
- 2022-01-20
- Completion
- 2022-01-20
Outcome
Outcome not reported
Stopped: “Company decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lirentelimab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | lirentelimab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | lirentelimab | Monoclonal antibody | 450 mg | Subcutaneous |