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New drug shows promise for rare Muscle-Weakening disease

NCT ID NCT04302103

Disease control Sponsor: RemeGen Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called RC18 in 29 adults with systemic myasthenia gravis, a condition that causes muscle weakness. The goal was to see if RC18 is safe and can help control symptoms. Participants received the drug while continuing their usual treatments, and researchers measured changes in muscle strength over 24 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

29 people

The number who actually took part.

Started

Jul 2020

Finished

Feb 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic myasthenia gravis

Contacts and locations

Locations

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, China

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, China

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, China

  • Beijing Hospital

    Beijing, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, China

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, China

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • Huashan Hospital, Fudan University

    Shanghai, China

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, China

  • Nanyang First People's Hospital

    Nanyang, Henan, China

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, China

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, China

  • The First Affiliated Hospital of USTC;Anhui Provincial Hospital

    Hefei, Anhui, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The First Hospital of Jilin University

    Changchun, Jilin, China

  • The Second Affiliated Hospital of Air Force Medical University

    Xi'an, Shaanxi, China

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, China

  • The Second Hospital & Clinical medical school ； Lanzhou University

    Lanzhou, China

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, China

  • West China Hospital, Sichuan University

    Xi'an, Shaanxi, China

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

    Chengdu, Sichuan, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China