Clinical trial NCT04302103: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Myasthenia Gravis
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 Ⅱ-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.

Primary outcomes:
measure: The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline
timeFrame: week 24
Secondary outcomes:
measure: 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
timeFrame: week 12，24
measure: The average variation of QMG score of the twelfth week compared to the OMG scores of baseline
timeFrame: week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Xianhao Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: