nctId: NCT06312475 id: KN057-A-301 briefTitle: Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors overallStatus: RECRUITING date: 2024-01-09 date: 2025-10-15 date: 2025-12-15 date: 2024-03-15 date: 2024-03-15 name: Suzhou Alphamab Co., Ltd. class: INDUSTRY briefSummary: 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 conditions: Hemophilia B With Inhibitor studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 51 type: ESTIMATED name: KN057 measure: Annualized bleeding rate (ABR) calculated based on treated spontaneous and traumatic bleeding episodes in Arm 1 and Arm 2. measure: ABR calculated based on bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1 and Arm 2. measure: ABR calculated based on bleeding episodes and treated bleeding episodes respectively in Arm 2. measure: ABR calculated based on bleeding episodes, treated bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1. measure: Change from baseline in Hemophilia Joint Health Score (HJHS) scores in Arm 1 and Arm 2. measure: Change in HJHS scores from baseline in Arm 1 and from the 26th week in Arm 2. measure: Change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) in Arm 1 and Arm 2. measure: Change in EQ-5D-5L from baseline in Arm 1 and from the 26th week in Arm 2. measure: Incidence of TEAE, TEAE related to the experimental drug and SAE. measure: Incidence of thromboembolic events, TMA and DIC. measure: Incidence of hypersensitivity type reactions. measure: Incidence of injection site reactions. measure: Incidence of clinically significant laboratory value abnormalities. measure: Number of participants with clinically significant changes from baseline in physical exam. measure: Number of participants with clinically significant changes from baseline in electrocardiograms. measure: Number of participants with clinically significant changes from baseline in vital signs. measure: KN057 plasma trough concentration. measure: Levels of Free TFPI. measure: Levels of prothrombin fragment 1+2 (PF1+2). measure: Incidence of anti-KN057 antibody (ADA) and neutralizing antibody (Nab). sex: MALE minimumAge: 12 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Tianjin state: Tianjin zip: 300020 country: China name: Renchi Yang, Doctor role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False