A Phase II Multicenter, Open Label Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and PK/PD Profile of Multiple Subcutaneous Injection of KN057 in Male Patients with Severe Hemophilia a or Moderate-to-Severe Hemophilia B with or Without Inhibitors

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.

Start Date02 Sep 2025

Sponsor / Collaborator

Suzhou Alphamab Co., Ltd.

CTR20234255

/ RecruitingPhase 3

在不伴抑制物的血友病A和血友病B患者中，评价KN057注射液预防治疗的有效性和安全性的随机、开放研究

[Translation] A randomized, open-label study to evaluate the efficacy and safety of KN057 injection for prophylactic treatment in patients with hemophilia A and hemophilia B without inhibitors

在不伴抑制物的血友病A（HA）和不伴抑制物的血友病B（HB）患者中，评估KN057预防治疗的有效性。

[Translation]

The efficacy of KN057 as a preventive therapy was evaluated in patients with hemophilia A (HA) without inhibitors and hemophilia B (HB) without inhibitors.

Start Date01 Apr 2024

Sponsor / Collaborator

Suzhou Alphamab Co., Ltd.

NCT06569108

/ RecruitingPhase 3

A Randomized, Open-label Study to Evaluate the Efficacy and Safety of KN057 Injection Prophylaxis in Patients With Hemophilia A or B Without Inhibitors

The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B without inhibitors and is safe to use. Participants receiving on-demand treatment prior to screening will be randomly assigned to Experimental group or Control group at a ratio of 2:1 in Part A. Participants receiving prophylaxis prior to screening will be nonrandomly assigned to Prophylaxis group in Part B. Participants in Experimental group will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in Control group will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks. Participants in Prophylaxis group will first receive prophylaxis with coagulation factor for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.

Start Date01 Apr 2024

Sponsor / Collaborator

Suzhou Alphamab Co., Ltd.

100 Clinical Results associated with Armocibart

100 Translational Medicine associated with Armocibart

100 Patents (Medical) associated with Armocibart

100 Deals associated with Armocibart

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Phase 3	China	Suzhou Alphamab Co., Ltd.	09 Jan 2024
Hemophilia B	Phase 3	China	Suzhou Alphamab Co., Ltd.	09 Jan 2024
Von Willebrand Diseases	Preclinical	United States	Suzhou Alphamab Co., Ltd.	18 Nov 2024

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20220429 \| CTR20201606 (Company_Website) Manual	Phase 1	Hemophilia	-	KN057	(cxxnvseaxi) = 1.0 mg/kg和2.5 mg/kg剂量组给药后 48h血药浓度达到峰值，半衰期在一周左右，且PK参数显示KN057呈现典型的非线性代谢特征, KN057浓度28 nM时作用达峰。 entjcinzxu (onkytcbuxr ) View more	Positive	28 Jun 2024

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