A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
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 adult patients with active eosinophilic duodenitis. Subjects who complete the randomized, double-blind, placebo-controlled treatment may have the option to receive 6 doses of open-label lirentelimab (AK002) through the OLE Period of the study.
Timeline
- Start
- 2021-05-20
- Primary completion
- 2022-06-14
- Completion
- 2023-01-09
Outcome
Mixed primary results
registry analysis (superiority test); 3.0 mg/kg of Lirentelimab (AK002) vs Placebo; p <0.0001; Percent Difference from Placebo 78.4 (95% CI 62.2 to 89.1); Fisher Exact NCT04856891 ↗
registry p = 0.8822; LSM Difference from Placebo 0.3 (95% CI -4.0 to 4.7); Mixed Models Analysis NCT04856891 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lirentelimab | Monoclonal antibody | 3 mg/kg | — |