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Systemic Myasthenia GravisPhase 2NCT04302103

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 Phase 2 study testing RC18 160mg and RC18 240 mg in people with Systemic Myasthenia Gravis, run by RemeGen Co., Ltd. at 24 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Systemic Myasthenia Gravis
What is being tested?
RC18 160mg and RC18 240 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
24 sitesChina
Study dates
7 Jul 2020to 11 Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 16Show fewer
  • 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;
  • Investigator considers candidates not appropriating for the study.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing

  • Beijing Hospital

    Beijing

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • West China School of Medicine；West China Hospital of Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of USTC;Anhui Provincial Hospital

    Hefei, Anhui

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

  • The Second Hospital & Clinical medical school ； Lanzhou University

    Lanzhou

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan

  • Nanyang First People's Hospital

    Nanyang, Henan

  • Huashan Hospital, Fudan University

    Shanghai

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • The Second Affiliated Hospital of Air Force Medical University

    Xi'an, Shaanxi

  • West China Hospital, Sichuan University

    Xi'an, Shaanxi

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou

Other trials in China

About this study

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

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

Being tested
RC18 160mg, RC18 240 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RC18 160mgBiological

    subcutaneous injection

  • RC18 240 mgBiological

    subcutaneous injection

Study groups in NCT04302103
Study groupRoleWhat they receive
RC18 160mgExperimentalPatients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
Receives: Biological: RC18 160mg
RC18 240 mgExperimentalPatients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
Receives: Biological: RC18 240 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: week 24

Secondary outcomes (2)

  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

    It is best that the assessors in each center are fixed during the study.

    Measured: week 12，24

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

    QMG score=Quantitative Myasthenia Gravis Score

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2020
  2. Study start7 Jul 2020
  3. Primary completion14 Jan 2022
  4. Study completion11 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04302103
Sponsor's protocol ID
18C011
Status last verified
Oct 2023
First submitted
6 Mar 2020
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yin J, Zhao M, Xu X, Zhang M, Xu Z, Li Z, Qin X, Li Z, Zhao C, Zhou H, Ma Y, Cao W, Wang G, Lin Y, Zhang J, Zhang X, Cai H, Qian W, Wang Y, Zhang X, Liu G, Wang J, Qiu W, Min L, Li J, Deng H, Chu L, Zhang Y, Fang J. A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis. Eur J Neurol. 2024 Aug;31(8):e16322. doi: 10.1111/ene.16322. Epub 2024 May 10.

    PubMed 38726639

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC18 160mg and RC18 240 mg in people with Systemic Myasthenia Gravis, run by RemeGen Co., Ltd. at 24 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The average variation of QMG scores of the twenty-fourth week compared to the QMG scores of baseline (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04302103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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