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

NCT ID: NCT04302103

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2022-02-11

Brief Summary

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

Conditions

Systemic Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RC18 160mg

Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.

Group Type: EXPERIMENTAL

RC18 160mg

Intervention Type: BIOLOGICAL

subcutaneous injection

RC18 240 mg

Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.

Group Type: EXPERIMENTAL

RC18 240 mg

Intervention Type: BIOLOGICAL

subcutaneous injection

Interventions

RC18 160mg

subcutaneous injection

Intervention Type: BIOLOGICAL

RC18 240 mg

subcutaneous injection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RemeGen Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xianhao Xu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Locations

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

18C011

Identifier Type: -

Identifier Source: org_study_id