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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

Sponsor
RemeGen Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04302103
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
23.3
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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
  • Biological: RC18 160mg
  • Biological: RC18 240 mg
 Phase 2

Study Design

Study Type:
Interventional
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 :
Jul 23, 2020
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Jul 1, 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 [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 [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 [week 12]

    QMG score=Quantitative Myasthenia Gravis Score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RemeGen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04302103
Other Study ID Numbers:
  • 18C011
First Posted:
Mar 10, 2020
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 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

Study Results

No Results Posted as of Jan 11, 2022