NCT06569108

Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

A Randomized, Open-label Study to Evaluate the Efficacy and Safety of KN057 Injection Prophylaxis in Patients With Hemophilia A or B Without Inhibitors

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Suzhou Alphamab Co., Ltd. · Industry
• Sex: Male
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B without inhibitors and is safe to use. Participants receiving on-demand treatment prior to screening will be randomly assigned to Experimental group or Control group at a ratio of 2:1 in Part A. Participants receiving prophylaxis prior to screening will be nonrandomly assigned to Prophylaxis group in Part B. Participants in Experimental group will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in Control group will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks. Participants in Prophylaxis group will first receive prophylaxis with coagulation factor for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.

Conditions

• Hemophilia A Without Inhibitor
• Hemophilia B Without Inhibitor

Interventions

Type	Name	Description
DRUG	KN057	KN057 will be administered subcutaneously once a week.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-10-15
• Completion: 2026-12-15
• First posted: 2024-08-23
• Last updated: 2025-09-17

Locations

1 site across 1 country: China