drugset / Trial / NCT05709093
A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase3 study is a randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of Lemzoparlimab for injection in combination with AZA versus AZA monotherapy as first-line therapy in treatment-naïve subjects with intermediate- and high-risk MDS.
Timeline
- Start
- 2023-03-30
- Primary completion
- 2024-04-01
- Completion
- 2024-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lemzoparlimab | Monoclonal antibody | 30 mg/kg | Intravenous |
| Comparator | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |