Back to resultsA Study of TACI（Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor）-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis
Primary Purpose
Systemic Myasthenia Gravis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
RC18 160mg
RC18 240 mg
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Myasthenia Gravis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Beijing Tiantan Hospital,Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
RC18 160mg
RC18 240 mg
Arm Description
Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
Outcomes
Primary Outcome Measures
The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline
QMG score=Quantitative Myasthenia Gravis Score
Secondary Outcome Measures
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.
The average variation of QMG score of the twelfth week compared to the OMG scores of baseline
QMG score=Quantitative Myasthenia Gravis Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04302103
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic myasthenia gravis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Myasthenia Gravis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RC18 160mg
Arm Type
Experimental
Arm Description
Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
Arm Title
RC18 240 mg
Arm Type
Experimental
Arm Description
Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
Intervention Type
Biological
Intervention Name(s)
RC18 160mg
Intervention Description
subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
RC18 240 mg
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline
Description
QMG score=Quantitative Myasthenia Gravis Score
Time Frame
week 24
Secondary Outcome Measure Information:
Title
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
Description
It is best that the assessors in each center are fixed during the study.
Time Frame
week 12，24
Title
The average variation of QMG score of the twelfth week compared to the OMG scores of baseline
Description
QMG score=Quantitative Myasthenia Gravis Score
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianhao Xu, M.D.
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
12. IPD Sharing Statement
Learn more about this trial
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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