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