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New shot could ease daily struggles for myasthenia gravis patients

NCT ID NCT06447597

Disease control Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests a new drug called B007 in 104 people with generalized myasthenia gravis, a condition that causes muscle weakness. Participants receive either B007 or a placebo as a shot under the skin twice a month. The goal is to see if B007 improves daily activities, like walking or eating, better than a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
B007 (a drug given as a shot under the skin)
What this could lead to
If it works, this could offer a new treatment option to help people with generalized myasthenia gravis manage their symptoms better.
What could go wrong
This is an early-to-mid stage trial with only 104 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are unknown.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

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. Sign informed consent form; 2. Subjects with generalized myasthenia gravis; 3. Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening; 4. MG-ADL ≥5 at screening and baseline; 5. Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test; 6. Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose. Exclusion Criteria: 1. Subjects with MGFA I and V type; 2. Subjects usingprescribed drugs; 3. Subjects with a prescribed disease or history of disease; 4. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator; 5. Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007; 6. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose; 7. Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening; 8. Pregnant and lactating women; 9. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose. 10. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose; 11. A history of alcohol or drug abuse within the past 12 months; 12. Other conditions deemed unsuitable for participation in this study by the researchers.

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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.

Generalized myasthenia gravis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Zunyi Medical College

    RECRUITING

    Zunyi, China

  • First People's Hospital of Yunnan Province

    RECRUITING

    Kunming, China

  • Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, China

  • Jiangxi Provincial People's Hospital

    RECRUITING

    Nanchang, China

  • Nanfang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, China

  • Peking University First Hospital

    RECRUITING

    Beijing, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, China

  • Shandong Provincial Qianfoshan Hospital

    RECRUITING

    Jinan, China

  • Shandong University Cheeloo College of Medicine

    RECRUITING

    Jinan, China

  • Shandong University Cheeloo College of Medicine

    RECRUITING

    Qingdao, China

  • Shenzhen Hospital of University of Hong Kong

    RECRUITING

    Shenzhen, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, China

  • Tangdu Hospital

    RECRUITING

    Xi'an, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The First Bethune Hospital of Jilin University

    RECRUITING

    Changchun, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • Tongji Medical College of HUST

    RECRUITING

    Wuhan, China

  • Xiangya Hospital Central South University

    RECRUITING

    Changsha, China

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