Clinical Trial

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

Active, Not Recruiting Phase 3
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Record status
This record was last updated September 17, 2025 (before its estimated October 15, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-08.
Status change: Recruiting → Active, Not Recruiting 2025-09-16
Trial Details
NCT Number NCT06312475
Lead Sponsor Suzhou Alphamab Co., Ltd.
Conditions Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Enrollment 53 participants
Start Date 2024-01-09
Primary Completion 2025-10-15 (estimated)
Study Completion 2025-12-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-17