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
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|ClinicalTrials.gov Identifier: NCT04302103|
Recruitment Status : Active, not recruiting
First Posted : March 10, 2020
Last Update Posted : January 11, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Systemic Myasthenia Gravis||Biological: RC18 160mg Biological: RC18 240 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 23, 2020|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||July 2022|
Experimental: RC18 160mg
Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
Biological: RC18 160mg
Experimental: RC18 240 mg
Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
Biological: RC18 240 mg
- The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline [ Time Frame: week 24 ]QMG score=Quantitative Myasthenia Gravis Score
- 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 [ Time Frame: week 12，24 ]It is best that the assessors in each center are fixed during the study.
- The average variation of QMG score of the twelfth week compared to the OMG scores of baseline [ Time Frame: week 12 ]QMG score=Quantitative Myasthenia Gravis Score
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302103
|Beijing Tiantan Hospital,Capital Medical University|
|Beijing, Beijing, China, 100070|
|Principal Investigator:||Xianhao Xu, M.D.||Beijing Hospital|
|Responsible Party:||RemeGen Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||March 10, 2020 Key Record Dates|
|Last Update Posted:||January 11, 2022|
|Last Verified:||January 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Nervous System Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Immune System Diseases