Generalized Myasthenia Gravis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Interventions
DRUGB007
B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15
DRUGPlacebo
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Sponsors
Shanghai Jiaolian Drug Research and Development Co., Ltd
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Sign informed consent form; 2. Subjects with generalized myasthenia gravis; 3. Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening; 4. MG-ADL ≥5 at screening and baseline; 5. Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test; 6. 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
1. Subjects with MGFA I and V type; 2. Subjects usingprescribed drugs; 3. Subjects with a prescribed disease or history of disease; 4. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator; 5. Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007; 6. 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; 7. Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening; 8. Pregnant and lactating women; 9. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose. 10. 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; 11. A history of alcohol or drug abuse within the past 12 months; 12. Other conditions deemed unsuitable for participation in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2 | Approximately 16 weeks | Proportion of subjects：MG-ADL decreased by ≥2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects：subjects without SoC（Standard of Care） change and MG-ADL decreased by ≥2 | Approximately 24 weeks | Proportion of subjects：subjects without SoC change and MG-ADL decreased by ≥2 |
| Proportion of subjects：subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3 | Approximately 24 weeks | Proportion of subjects：subjects without SoC change and QMG decreased by ≥3 |
| Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline. | Approximately 24 weeks | Changes in MGQoL15r from baseline. |
| Changes in MGC (Myasthenia gravis composite) from baseline. | Approximately 24 weeks | Changes in MGC from baseline |
| Incidence of Treatment-Emergent Adverse Events | Approximately 1 years | Adverse event type, incidence, duration |
Countries
China
Contacts
CONTACTJianying Xi
CONTACTHuan Yang
Outcome results
None listed