KN057 Prophylaxis Phase 3 Haemophilia A or B Study
ClinicalTrials.gov Studies
Summary
The NIH ClinicalTrials.gov registry published a record for NCT07545395, a Phase 3 open-label multicenter clinical trial evaluating the safety and efficacy of long-term prophylactic treatment with KN057 in patients with Haemophilia A or B, with or without inhibitors. The trial includes a pharmacokinetic assessment comparing old and new manufacturing processes for KN057, with participants in Part PK randomized 1:1 between old and new process groups for 26 weeks each, and Part non-PK participants treated with new process KN057 for 52 weeks. Participants may be drawn from prior KN057-A-301 or KN057-A-302 studies.
“The purposes of this open-label, multicenter III clinical trial are to evaluate the safety and efficacy of long-term preventive treatment with KN057 in Haemophilia A or B patients with or without inhibitors, and to assess the pharmacokinetic characteristics of the new and old processes KN057.”
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What changed
This ClinicalTrials.gov registry entry documents the initiation of NCT07545395, a Phase 3 clinical trial for KN057, an investigational prophylaxis therapy for haemophilia A or B. The trial is structured with a pharmacokinetic arm comparing old and new manufacturing processes in a randomized crossover design, and a non-randomized arm assessing the new process over 52 weeks. For pharmaceutical manufacturers and clinical research organisations, this registry entry signals active Phase 3 development activity for KN057, which may inform pipeline planning, partnership assessments, and competitive landscape analysis for haemophilia therapies.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Safety of KN057 Prophylaxis in Patients With Haemophilia A or B
Phase 3 NCT07545395 Kind: PHASE3 Apr 22, 2026
Abstract
The purposes of this open-label, multicenter III clinical trial are to evaluate the safety and efficacy of long-term preventive treatment with KN057 in Haemophilia A or B patients with or without inhibitors, and to assess the pharmacokinetic characteristics of the new and old processes KN057.
The participants in Part PK will be randomly assigned to Old process Group or New process Group in a 1:1 ratio. The participants in Old process Group will receive old process KN057 prophylaxis for the first 26 weeks and new process KN057 prophylaxis for the following 26 weeks. The participants in New process Group will receive new process KN057 prophylaxis for both the first 26 weeks and the last 26 weeks.
The participants in Part non-PK will be non-randomized and treated with new process KN057 for 52 weeks prophylaxis after enrollment.
Priority screening and enrollment of participants who have participated in the KN057-A-301 or KN057-A-302 study.
Conditions: Hemophilia A or B
Interventions: KN057
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