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

Launched by SUZHOU ALPHAMAB CO., LTD. · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KN057 to see if it can help prevent bleeding episodes in men with Hemophilia A or B who have inhibitors. Inhibitors are antibodies that can make standard treatments for hemophilia less effective. The trial will involve two groups: one group will receive KN057 for a full year, while the other group will first get on-demand treatment for six months and then switch to KN057 for the next six months. Overall, the study will last for about 59 weeks, which includes time for screening participants and follow-up after treatment.

To be eligible for this trial, participants must be male, aged 12 to 70, weigh at least 25 kg, and have a high level of inhibitors in their blood. They should have experienced at least six bleeding episodes in the last six months. It’s important to note that certain health conditions, like serious chronic diseases or a history of blood clots, may exclude someone from joining the study. Participants in the trial will be closely monitored for safety and effectiveness of the treatment throughout the study period.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male, 12 to 70 years old at the time of signing informed consent (including the cut-off value), body weight ≥25 kg and BMI \<28 kg/m\^2 at screening;
• • 2. The FVIII or FIX inhibitor test is positive at a high titer (≥5 BU/ml) during the screening period; or the FVIII or FIX inhibitor is detected at a low titer (0.6 BU/ml or the upper limit of normal value \< inhibitor titer \< 5 BU/ml) during the screening period and treatment with bypass agents (rFVIIa or PCC) has been started;
• • 3. ≥6 treated bleeding episodes within 26 weeks before screening;
• • 4. Have not used TFPI antibody drugs before;
• • 5. Be able and agree to elute prior drugs for the treatment of hemophilia.
• Exclusion Criteria:
• • 1. Have serious or poorly controlled chronic diseases or obvious systemic diseases;
• • 2. Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic/antithrombotic therapy;
• • 3. Have high-risk factors for thrombosis: such as a history of coronary atherosclerotic disease, ischemic disease of important organs, vascular occlusive disease, autoimmune diseases with a high risk of thrombosis, or indwelling central venous catheter;
• • 4. The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B;
• • 5. Being on standard prophylaxis and maintaining it for more than 12 weeks (standard prophylaxis is defined as at least 80% compliance with a predetermined prophylaxis regimen);
• • 6. Ongoing or planned Immune Tolerance Induction treatment;
• • 7. When bleeding occurred in the past, rFVIIa was ineffective and PCC treatment must be used;
• • 8. Known or suspected hypersensitivity to any constituent of the trial product or related products;
• • 9. Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study.