drugset / Trial / NCT06593938
A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.
Timeline
- Start
- 2024-10-25
- Primary completion
- 2025-07-31
- Completion
- 2025-07-31
Outcome
Met primary endpoint
release “在未接受过补体抑制剂治疗的PNH患者中，口服HRS-5965在提升血红蛋白水平、减少输血依赖和改善生活质量方面均显著优于依库珠单抗” hengrui.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eculizumab | Monoclonal antibody | — | — |
| Subject | HRS-5965 | Small molecule | — | — |