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

• ClinicalTrials.gov Identifier: NCT04302103
• Recruitment Status: Active, not recruiting
• First Posted: March 10, 2020
• Last Update Posted: January 11, 2022
• Sponsor: RemeGen Co., Ltd.
• Information provided by (Responsible Party): RemeGen Co., Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Systemic Myasthenia Gravis	Biological: RC18 160mg; Biological: RC18 240 mg	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 23, 2020
• Estimated Primary Completion Date: February 2022
• Estimated Study Completion Date: July 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline [ Time Frame: week 24 ]
   QMG score=Quantitative Myasthenia Gravis Score

Secondary Outcome Measures :

1. 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 [ Time Frame: week 12，24 ]
   It is best that the assessors in each center are fixed during the study.
2. The average variation of QMG score of the twelfth week compared to the OMG scores of baseline [ Time Frame: week 12 ]
   QMG score=Quantitative Myasthenia Gravis Score

Eligibility Criteria

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

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.

Contacts and Locations

Locations

China, Beijing

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing, China, 100070

Sponsors and Collaborators

RemeGen Co., Ltd.

Investigators

• Principal Investigator: Xianhao Xu, M.D.; Beijing Hospital

More Information

• Responsible Party: RemeGen Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04302103
• Other Study ID Numbers: 18C011
• First Posted: March 10, 2020
• Last Update Posted: January 11, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Myasthenia Gravis; Muscle Weakness; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases