Systemic Myasthenia Gravis Clinical Trial
Official title:
A Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Systemic Myasthenia Gravis
| Verified date | October 2023 |
| Source | RemeGen Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic myasthenia gravis.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | February 11, 2022 |
| Est. primary completion date | January 14, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: 1. Voluntarily signed informed consent ; 2. Patient diagnosed with systemic myasthenia gravis according to The following conditions. 3. Seropositive at screening for AChR(Acetylcholine receptor)-Ab or MuSK(Muscle specific tyrosine kinase)-Ab; 4. MGFA(Myasthenia Gravis Foundation of America) Clinical classification ?-IIIb; 5. QMG score=8,and QMG score>2 in four or more items; 6. Maintained any one of the stable standard treatment programs in the trial protocol. Exclusion Criteria: 1. Combined autoimmune diseases, such as systemic lupus erythematosus,rheumatoid arthritis, systemic sclerosis and so on,except for hypothyroidism and hyperthyroidism; 2. Abnormal laboratory parameters need to be excluded, including but not limited to: 3. Immunosuppressive agents except agents of standard treatment programs were used within one month prior to randomization.; 4. Use of biological agents for targeted therapy within 6 months prior to randomization; 5. Intravenous immunoglobulin therapy or plasma exchange therapy within 2 months before randomization; 6. Active infection during screening(For example,herpes zoster,HIV antibody positive,active tuberculosis,etc); 7. Currently suffering from active hepatitis or severe liver lesions and history; 8. Diabetics with poor blood sugar control:HbAlc>9.0% or FBG=11.1mmol/L; 9. Currently having a thymic tumor ,or had a thymectomy within 6 months prior to screening; 10. Received live vaccines within 3 months before randomization,or scheduled to administer vaccine during the trial; 11. Malignant tumor patients; 12. Allergic to human biological preparations; 13. Have participated in any clinical trial within 28 days before randomization,or in 5 times half-life period of the drugs of any clinical trial(taking the longer time). 14. Pregnant , lactating women and men or women who have birth plans during the research; 15. Having alcohol or drug abuse that affect the experimental conditions; 16. Investigator considers candidates not appropriating for the study. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Tiantan Hospital,Capital Medical University | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| RemeGen Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline | QMG score=Quantitative Myasthenia Gravis Score | week 24 | |
| Secondary | The average variation of clinical absolute score for myasthenia gravis of the twelfth and twenty-fourth weeks compared to Clinical absolute score for myasthenia gravis of baseline | It is best that the assessors in each center are fixed during the study. | week 12,24 | |
| Secondary | The average variation of QMG score of the twelfth week compared to the OMG scores of baseline | QMG score=Quantitative Myasthenia Gravis Score | week 12 |