A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.

Last updated: October 29, 2024
Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Overall Status: Active - Recruiting

Phase

2/3

Condition

Sarcopenia

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Treatment

B007

Placebo

Clinical Study ID

NCT06447597
SPH-B007-303
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.

Eligibility Criteria

Inclusion

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, andmaintain a stable dose throughout the test;

  6. Subjects agree to use effective contraceptive methods for contraception from signingthe informed consent form to 1 year after the last dose. Female subjects consideredfertile by the investigator must have negative serum pregnancy tests before thefirst dose.

Exclusion

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 asunsuitable for participation in the study by the investigator;

  5. Known history of severe allergic reaction to humanized monoclonal antibodies, orknown allergy to any component of B007;

  6. Subjects who received live vaccine at the specified time before the first dose andare 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 trialswithin the prescribed time before screening;

  8. Pregnant and lactating women;

  9. Fertile female subjects do not agree to use effective contraception from signing theinformed consent form to 1 years after the last dose.

  10. Sexually active male subjects who do not intend to use an effective contraceptivemethod during the trial period or within1 years after the last dose, or malesubjects who plan to donate sperm during the trial or within 1 year after the lastdose;

  11. A history of alcohol or drug abuse within the past 12 months;

  12. Other conditions deemed unsuitable for participation in this study by theresearchers.

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: B007
Phase: 2/3
Study Start date:
July 01, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun,
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha,
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu,
    China

    Active - Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou,
    China

    Active - Recruiting

  • Shandong Provincial Qianfoshan Hospital

    Jinan,
    China

    Active - Recruiting

  • Shandong University Cheeloo College of Medicine

    Jinan,
    China

    Active - Recruiting

  • First People's Hospital of Yunnan Province

    Kunming,
    China

    Active - Recruiting

  • Jiangxi Provincial People's Hospital

    Nanchang,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Active - Recruiting

  • Shandong University Cheeloo College of Medicine

    Qingdao,
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai,
    China

    Active - Recruiting

  • Shenzhen Hospital of University of Hong Kong

    Shenzhen,
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan,
    China

    Active - Recruiting

  • Tongji Medical College of HUST

    Wuhan,
    China

    Active - Recruiting

  • Tangdu Hospital

    Xi'an,
    China

    Active - Recruiting

  • Affiliated Hospital of Zunyi Medical College

    Zunyi,
    China

    Active - Recruiting

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