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

May 21, 2026 updated by: RemeGen Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Hospital
      • Beijing, China
        • Beijing AnZhen Hospital, Capital Medical University
      • Beijing, China
        • Beijing Tongren Hospital, Capital Medical University
      • Beijing, China
        • Beijing Tiantan Hospital, Capital Medical University
      • Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
      • Guangzhou, China
        • The Third Affiliated Hospital, Sun Yat-Sen University
      • Lanzhou, China
        • The Second Hospital & Clinical medical school ； Lanzhou University
      • Shanghai, China
        • Huashan Hospital, Fudan University
    • Anhui
      • Bengbu, Anhui, China
        • The First Affiliated Hospital of Bengbu Medical University
      • Hefei, Anhui, China
        • The First Affiliated Hospital of USTC;Anhui Provincial Hospital
    • Guizhou
      • Zunyi, Guizhou, China
        • Affiliated Hospital of Zunyi Medical University
    • Henan
      • Nanyang, Henan, China
        • Nanyang First People's Hospital
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital of Central South University
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Jiangxi Provincial People's Hospital
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University
    • Liaoning
      • Dalian, Liaoning, China
        • The Second Affiliated Hospital of Dalian Medical University
      • Jinzhou, Liaoning, China
        • The First Affiliated Hospital of Jinzhou Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The Second Affiliated Hospital of Air Force Medical University
      • Xi'an, Shaanxi, China
        • West China Hospital, Sichuan University
    • Shanxi
      • Taiyuan, Shanxi, China
        • First Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China School of Medicine；West China Hospital of Sichuan University
      • Nanchong, Sichuan, China
        • Affiliated Hospital of North Sichuan Medical College
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital
      • Wenzhou, Zhejiang, China
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: week 12，24
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
Time Frame: week 12
QMG score=Quantitative Myasthenia Gravis Score
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RemeGen Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xianhao Xu, M.D., Beijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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