Recruiting NCT06447597
A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B007, Placebo.
- Who it may be relevant to
- Registry conditions: Generalized Myasthenia Gravis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Generalized Myasthenia Gravis
Overview
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Interventions
- Drug B007
B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15 - Drug Placebo
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Primary outcome measures
- Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2 [Time frame: Approximately 16 weeks]
Secondary outcome measures (5)
- Proportion of subjects：subjects without SoC（Standard of Care） change and MG-ADL decreased by ≥2 [Time frame: Approximately 24 weeks]
- Proportion of subjects：subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3 [Time frame: Approximately 24 weeks]
- Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline. [Time frame: Approximately 24 weeks]
- Changes in MGC (Myasthenia gravis composite) from baseline. [Time frame: Approximately 24 weeks]
- Incidence of Treatment-Emergent Adverse Events [Time frame: Approximately 1 years]
Eligibility criteria
Inclusion criteria
- Sign informed consent form;
- Subjects with generalized myasthenia gravis;
- Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
- MG-ADL ≥5 at screening and baseline;
- Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
- Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose.
Exclusion criteria
- Subjects with MGFA I and V type;
- Subjects usingprescribed drugs;
- Subjects with a prescribed disease or history of disease;
- The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
- Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
- Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
- Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
- Pregnant and lactating women;
- Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
- Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose;
- A history of alcohol or drug abuse within the past 12 months;
- Other conditions deemed unsuitable for participation in this study by the researchers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 18 centers
- Peking University First Hospital — Beijing
- The First Bethune Hospital of Jilin University — Changchun
- Xiangya Hospital Central South University — Changsha
- Sichuan Provincial People's Hospital — Chengdu
- Nanfang Hospital, Southern Medical University — Guangzhou
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
- Shandong Provincial Qianfoshan Hospital — Jinan
- Shandong University Cheeloo College of Medicine — Jinan
- … and 10 more centers
Identifiers
NCT: NCT06447597 · SPH-B007-303