NCT06312475

Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors

A Randomized, Open-label Study to Evaluate the Efficacy and Safety of KN057 Injection Prophylaxis in Patients With Hemophilia A or B With Inhibitors

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (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 with inhibitors and is safe to use. Successfully screened participants will be randomly assigned to KN057 Prophylaxis (Arm 1) versus No Prophylaxis (Arm 2) at a ratio of 2:1. Participants in KN057 Prophylaxis will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in No Prophylaxis will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.The trial period is 59 weeks, including a 3-week screening period, a 26-week main trial, a 26-week extension period, and a 4-week follow-up period after the last administration.

Conditions

• Hemophilia A With Inhibitor
• Hemophilia B With Inhibitor

Interventions

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

Timeline

• Start date: 2024-01-09
• Primary completion: 2025-10-15
• Completion: 2025-12-15
• First posted: 2024-03-15
• Last updated: 2025-09-17

Locations

1 site across 1 country: China