Status:
COMPLETED
A Study of TACI（Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor）-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis
Lead Sponsor:
RemeGen Co., Ltd.
Conditions:
Systemic Myasthenia Gravis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic myasthenia gravis.
Eligibility Criteria
Inclusion
- Voluntarily signed informed consent ;
- Patient diagnosed with systemic myasthenia gravis according to The following conditions.
- Seropositive at screening for AChR（Acetylcholine receptor）-Ab or MuSK（Muscle specific tyrosine kinase）-Ab;
- MGFA（Myasthenia Gravis Foundation of America） Clinical classification Ⅱ-IIIb;
- QMG score≥8,and QMG score\>2 in four or more items;
- Maintained any one of the stable standard treatment programs in the trial protocol.
Exclusion
- Combined autoimmune diseases, such as systemic lupus erythematosus,rheumatoid arthritis, systemic sclerosis and so on,except for hypothyroidism and hyperthyroidism;
- Abnormal laboratory parameters need to be excluded, including but not limited to:
- Immunosuppressive agents except agents of standard treatment programs were used within one month prior to randomization.;
- Use of biological agents for targeted therapy within 6 months prior to randomization;
- Intravenous immunoglobulin therapy or plasma exchange therapy within 2 months before randomization;
- Active infection during screening(For example,herpes zoster,HIV antibody positive,active tuberculosis,etc);
- Currently suffering from active hepatitis or severe liver lesions and history;
- Diabetics with poor blood sugar control:HbAlc\>9.0% or FBG≥11.1mmol/L;
- Currently having a thymic tumor ,or had a thymectomy within 6 months prior to screening;
- Received live vaccines within 3 months before randomization,or scheduled to administer vaccine during the trial;
- Malignant tumor patients;
- Allergic to human biological preparations;
- 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).
- Pregnant , lactating women and men or women who have birth plans during the research;
- Having alcohol or drug abuse that affect the experimental conditions;
- Investigator considers candidates not appropriating for the study.
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04302103
Start Date
July 7 2020
End Date
February 11 2022
Last Update
October 11 2023
Active Locations (1)
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1
Beijing Tiantan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100070