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

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

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

Study Overview

• Status: Completed
• Conditions: Systemic Myasthenia Gravis
• Intervention / Treatment: Biological: RC18 160mg; Biological: RC18 240 mg

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital,Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RC18 160mg; Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.	Biological: RC18 160mg; subcutaneous injection
Experimental: RC18 240 mg; Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.	Biological: RC18 240 mg; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline	QMG score=Quantitative Myasthenia Gravis Score	week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 12，24
The average variation of QMG score of the twelfth week compared to the OMG scores of baseline	QMG score=Quantitative Myasthenia Gravis Score	week 12

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.
• Investigators: Principal Investigator: Xianhao Xu, M.D., Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): February 11, 2022

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Neoplasms by Site; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Muscle Weakness; Myasthenia Gravis
• Other Study ID Numbers: 18C011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No