A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis
Summary
This is a Phase 2/3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002) given monthly for 6 doses in adult and adolescent patients with active eosinophilic esophagitis. 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
- 2020-07-06
- Primary completion
- 2021-06-04
- Completion
- 2022-01-18
Outcome
Mixed primary results
registry analysis (superiority test); 1 mg/kg of Lirentelimab (AK002) vs Placebo; p <0.0001; Percent Difference from Placebo 81.6 (95% CI 71.5 to 89.0); Fisher Exact NCT04322708 ↗
registry analysis (superiority test); 1 mg/kg of Lirentelimab (AK002) vs Placebo; p = 0.2470; LSM Difference from Placebo 2.7 (95% CI -1.9 to 7.3); ANCOVA NCT04322708 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lirentelimab | Monoclonal antibody | 1 mg/kg | — |
| Subject | lirentelimab | Monoclonal antibody | 3 mg/kg | — |