Not Yet RecruitingPhase 2

KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors

24 participantsStarted 2025-09-02

Plain-language summary

The goal of this clinical trial is to evaluate the safety and efficacy of KN057 in adult patients with severe Hemophilia A (coagulation factor FVIII activity \<1%) or moderate-to-severe Hemophilia B (FIX activity ≤2%). Participants will be administered subcutaneously with KN057 once a week for 20 weeks. KN057 works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly subcutaneous administration provides better convenience and compliance.

Who can participate

Age range

18 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male, 18-70 years old (including thresholds), body weight ≥40 kg and BMI \<30 kg/m\^2.
. Severe Hemophilia A or moderate-to-severe Hemophilia B (coagulation factor FVIII activity \<1% or FIX activity ≤2%).
. Have ≥ 6 treated bleeding episodes within 24 weeks prior to screening (spontaneous and/or traumatic, excluding bleeding episodes related to surgery or traumatic operation).
. Patients without inhibitors must meet the following criteria: FVIII or FIX inhibitor test is negative during the screening period. Use coagulation factor replacement therapy for no less than 100 exposure days before screening.
. Patients with inhibitors must meet the following criteria: FVIII or FIX inhibitor test is positive during the screening period. Inhibitors level with high titer positive (≥5 BU/ml) or current low titer positive (\<5 BU/ml) refractory to FVIII or FIX replacement and with FVIII or FIX recovery \< 60% of expected within previous 12 months prior to screening.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and severity of treatment emergent adverse events(TEAEs)

Timeframe: Week 0 up to Week 26

Number of participants with abnormal laboratory findings in Hematology

Timeframe: Week 0 up to Week 26

Number of participants with abnormal laboratory findings in Coagulation Function

Timeframe: Week 0 up to Week 26

Number of participants with abnormal laboratory findings in Blood Biochemistry

Timeframe: Week 0 up to Week 26

Number of participants with clinically significant changes in 12-lead electrocardiograms

Timeframe: Week 0 up to Week 26

Number of participants with clinically significant changes in vital signs

Timeframe: Week 0 up to Week 26

Number of participants with clinically significant changes in physical examination Findings

Timeframe: Week 0 up to Week 26

Trial details

NCT IDNCT06747416

SponsorSuzhou Alphamab Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-02

Contact for this trial

Yanrong Dong Master

+86 18914005458 yanrongdong@alphamab.com

View on ClinicalTrials.gov More Hemophilia a and B trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male, 18-70 years old (including thresholds), body weight ≥40 kg and BMI \<30 kg/m\^2.
. Severe Hemophilia A or moderate-to-severe Hemophilia B (coagulation factor FVIII activity \<1% or FIX activity ≤2%).
. Have ≥ 6 treated bleeding episodes within 24 weeks prior to screening (spontaneous and/or traumatic, excluding bleeding episodes related to surgery or traumatic operation).
. Patients without inhibitors must meet the following criteria: FVIII or FIX inhibitor test is negative during the screening period. Use coagulation factor replacement therapy for no less than 100 exposure days before screening.
. Patients with inhibitors must meet the following criteria: FVIII or FIX inhibitor test is positive during the screening period. Inhibitors level with high titer positive (≥5 BU/ml) or current low titer positive (\<5 BU/ml) refractory to FVIII or FIX replacement and with FVIII or FIX recovery \< 60% of expected within previous 12 months prior to screening.

What they're measuring

Incidence and severity of treatment emergent adverse events(TEAEs)

Timeframe: Week 0 up to Week 26

Number of participants with abnormal laboratory findings in Hematology

Timeframe: Week 0 up to Week 26

Number of participants with abnormal laboratory findings in Coagulation Function

Timeframe: Week 0 up to Week 26

Number of participants with abnormal laboratory findings in Blood Biochemistry

Timeframe: Week 0 up to Week 26

Number of participants with clinically significant changes in 12-lead electrocardiograms

Timeframe: Week 0 up to Week 26

Number of participants with clinically significant changes in vital signs

Timeframe: Week 0 up to Week 26

Number of participants with clinically significant changes in physical examination Findings

Timeframe: Week 0 up to Week 26

KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria