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

NCT06593938

Phase 3 Completed 76 enrolled Chengdu Suncadia Medicine Co., Ltd.
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

Drugs

EvaluationDrugModalityDoseRoute
Subject Eculizumab Monoclonal antibody
Subject HRS-5965 Small molecule