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

NCT04302103 | Completed Phase 2

• 1 other identifier: 18C011
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• The average variation of QMG score of the twelfth week compared to the OMG scores of baseline

  week 12

Study Arms (2)

RC18 160mg

EXPERIMENTAL

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

Biological: RC18 160mg

RC18 240 mg

EXPERIMENTAL

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

Biological: RC18 240 mg

Interventions

RC18 160mg BIOLOGICAL

subcutaneous injection

RC18 160mg

RC18 240 mg BIOLOGICAL

subcutaneous injection

RC18 240 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed informed consent ;
• Patient diagnosed with systemic myasthenia gravis according to The following conditions.
• Seropositive at screening for AChR（Acetylcholine receptor）-Ab or MuSK（Muscle specific tyrosine kinase）-Ab;
• MGFA（Myasthenia Gravis Foundation of America） Clinical classification Ⅱ-IIIb;
• QMG score≥8,and QMG score\>2 in four or more items;
• Maintained any one of the stable standard treatment programs in the trial protocol.

You may not qualify if:

• Combined autoimmune diseases, such as systemic lupus erythematosus,rheumatoid arthritis, systemic sclerosis and so on,except for hypothyroidism and hyperthyroidism;
• Abnormal laboratory parameters need to be excluded, including but not limited to:
• Immunosuppressive agents except agents of standard treatment programs were used within one month prior to randomization.;
• Use of biological agents for targeted therapy within 6 months prior to randomization;
• Intravenous immunoglobulin therapy or plasma exchange therapy within 2 months before randomization;
• Active infection during screening(For example,herpes zoster,HIV antibody positive,active tuberculosis,etc);
• Currently suffering from active hepatitis or severe liver lesions and history;
• Diabetics with poor blood sugar control:HbAlc\>9.0% or FBG≥11.1mmol/L;
• Currently having a thymic tumor ,or had a thymectomy within 6 months prior to screening;
• Received live vaccines within 3 months before randomization,or scheduled to administer vaccine during the trial;
• Malignant tumor patients;
• Allergic to human biological preparations;
• 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).
• Pregnant , lactating women and men or women who have birth plans during the research;
• Having alcohol or drug abuse that affect the experimental conditions;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Interventions

RC-18

Study Officials

• Xianhao Xu, M.D.

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: July 7, 2020
• Primary Completion: January 14, 2022
• Study Completion: February 11, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

CN (1)