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

Phase 2

Completed

• Conditions: Systemic Myasthenia Gravis
• Interventions: Biological: RC18 160mg; Biological: RC18 240 mg

• Registration Number: NCT04302103
• Lead Sponsor: RemeGen Co., Ltd.

Brief Summary

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic myasthenia gravis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Study Start: 2020-07-07
• Primary Completion: 2022-01-14
• Study Completion: 2022-02-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RC18 160mg	RC18 160mg	Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
RC18 240 mg	RC18 240 mg	Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.

Primary Outcome Measures

Name	Time	Method
The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline	week 24	QMG score=Quantitative Myasthenia Gravis Score

Secondary Outcome Measures

Name	Time	Method
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	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	week 12	QMG score=Quantitative Myasthenia Gravis Score

Trial Locations

Locations (1)

Beijing Tiantan Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China