Patient recruitment: clinical trial of patients with systemic myasthenia gravis

Drug Information: Bartolizumab (HBM9161) Bartolizumab (HBM9161) is a fully human monoclonal antibody (mAb) that can block the binding of FcRn-IgG to each other and accelerate the elimination of IgG in the body, thereby achieving effective The effect of treating pathogenic IgG-mediated autoimmune diseases
.
The available evidence suggests that the reduction of IgG levels in patients with myasthenia gravis is associated with clinical benefit
.
Early studies have shown that bartolizumab is well tolerated and can rapidly reduce total IgG
.
Studies have also shown that bartolizumab is the first anti-FcRn target drug that has been proven to continuously reduce IgG after subcutaneous injection (SC) in Chinese and Caucasian populations.
Bartolizumab has been used in the treatment of gMG in China.
The Food and Drug Administration awarded "Breakthrough Therapy"
.
Hebo Medicine's bartolizumab (HBM9161) has been reviewed and approved by the National Medical Products Administration to conduct clinical trials
.
From now on, we plan to recruit subjects who voluntarily participate in the study
.
Project introduction At present, "evaluating the effectiveness and safety of HBM9161 (HL161) subcutaneous injection in the treatment of patients with systemic myasthenia gravis is a multi-center, randomized, double-blind, placebo-controlled, seamless/group sequential operation for phase 2/3 Designed a clinical study", the study has been approved by the ethics committee
.
The research drug HBM9161 (HL161BKN) injection is an anti-FcRn fully human monoclonal antibody) HBM9161 is not yet on the market.
The new global biological product with complete intellectual property rights introduced by the sponsor and Platinum Medicine has been approved by the National Medical Products Administration.
The reviewer agreed to carry out clinical trials
.
This research plan recruits about 144 patients with systemic myasthenia gravis who meet the research requirements
.
Participant selection criteria 1.
Voluntary signing of written informed consent 2.
Male or female aged ≥ 18 years 3.
Comply with MGFA myasthenia gravis clinical classification IIa-IVa (including IIa, IIb, IIIa, IIIb and IVa) 4 .
During the entire study period from the signing of the informed consent form and within 14 days after the final visit, women and men of fertility need to take effective contraceptive measures.
Part of the selection criteria, if you need to know more about it, please contact the research doctor for communication
.
Whether you meet the research requirements requires a series of inspections and judgments, subject to the judgment of the research doctor
.
If you confirm that you meet the selection requirements, you will receive: 1.
Research drugs provided by the sponsor 2.
Regular visits and medical examinations related to the research If you are considering participating in this research or consulting this research related information, please Contact the center below
.
About myasthenia gravis Myasthenia gravis (MG) is a neuromuscular disease mediated by pathogenic IgG that seriously affects the quality of life
.
In China, about 250,000 patients suffer from myasthenia gravis.
Existing treatments cannot effectively control the disease.
New effective and safe treatments are urgently needed
.
About Bartolizumab (HBM9161) Bartolizumab (HBM9161) is a fully human monoclonal antibody (mAb) that can block the binding of FcRn-IgG to each other, accelerate the elimination of IgG in the body, and achieve effective treatment.
Pathological IgG-mediated autoimmune disease effects
.
The available evidence suggests that the reduction of IgG levels in patients with myasthenia gravis is associated with clinical benefit
.
Early studies have shown that bartolizumab is well tolerated and can quickly reduce total IgG
.
Studies have also shown that bartolizumab is the first anti-FcRn target drug that has been proven to continuously reduce IgG after subcutaneous injection (SC) in Chinese and Caucasian populations.
Bartolizumab has been used in the treatment of gMG in China.
The Food and Drug Administration awarded "Breakthrough Therapy"
.
About Hebo Medicine Hebo Medicine (stock code: 02142.
HK) is a global biopharmaceutical company focusing on the research and development and commercialization of innovative drugs in the field of tumors and immune diseases
.
The company rapidly expands its innovative drug research and development pipeline through independent research and development, joint development and diversified cooperation models
.
Harbour Mice®, Hebo's own antibody technology platform, can generate fully human monoclonal antibodies in the form of double, double light chain (H2L2) and heavy chain only (HCAb)
.
The immune cell adapter (HBICETM) developed based on the HCAb antibody platform can achieve anti-tumor effects that cannot be achieved by traditional drug combination therapy
.
Harbour Mice® and the monoclonal B cell screening platform together form Hebo's next-generation innovative therapeutic antibody R&D engine
.
Transfer from: Seeking a doctor for medicine, and platinum medicine