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

April 29, 2026 updated by: Shanghai Jiaolian Drug Research and Development Co., Ltd

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Generalized Myasthenia Gravis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Feng Gao
      • Changchun, China
        • Recruiting
        • The First Bethune Hospital Of Jilin University
        • Contact:
          • Hui Deng
      • Changsha, China
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Huan yang
      • Chengdu, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Fei Xu
      • Guangzhou, China
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Haishan Jiang
      • Hangzhou, China
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Qing Ke
      • Jinan, China
        • Recruiting
        • Shandong Provincial Qianfoshan Hospital
        • Contact:
          • Ruisheng Duan
      • Jinan, China
        • Recruiting
        • Shandong University Cheeloo College of Medicine
        • Contact:
          • Wei Li
      • Kunming, China
        • Recruiting
        • First People's Hospital of Yunnan Province
        • Contact:
          • Qiang Meng
      • Nanchang, China
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Jianglong Tu
      • Nanchang, China
        • Recruiting
        • Jiangxi Provincial People's Hospital
        • Contact:
          • Rensi Xu
      • Qingdao, China
        • Recruiting
        • Shandong University Cheeloo College of Medicine
        • Contact:
          • Cuiping Zhao
      • Shanghai, China
        • Recruiting
        • Huashan Hospital, Fudan University
        • Contact:
          • jianying Xi
      • Shenzhen, China
        • Recruiting
        • Shenzhen Hospital of University of Hong Kong
        • Contact:
          • Haibing Xiao
      • Wuhan, China
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
          • Zuneng Lu
      • Wuhan, China
        • Recruiting
        • TongJi Medical College of HUST
        • Contact:
          • Bitao Bu
      • Xi'an, China
        • Recruiting
        • Tangdu Hospital
        • Contact:
          • Ting Chang
      • Zunyi, China
        • Recruiting
        • Affiliated Hospital of Zunyi Medical College
        • Contact:
          • Zucai Xu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Experimental: B007
Drug: B007
B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2
Time Frame: Approximately 16 weeks
Proportion of subjects：MG-ADL decreased by ≥2
Approximately 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: Approximately 1 years
Adverse event type, incidence, duration
Approximately 1 years
Proportion of subjects：subjects without SoC（Standard of Care） change and MG-ADL decreased by ≥2
Time Frame: Approximately 24 weeks
Proportion of subjects：subjects without SoC change and MG-ADL decreased by ≥2
Approximately 24 weeks
Proportion of subjects：subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3
Time Frame: Approximately 24 weeks
Proportion of subjects：subjects without SoC change and QMG decreased by ≥3
Approximately 24 weeks
Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.
Time Frame: Approximately 24 weeks
Changes in MGQoL15r from baseline.
Approximately 24 weeks
Changes in MGC (Myasthenia gravis composite) from baseline.
Time Frame: Approximately 24 weeks
Changes in MGC from baseline
Approximately 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Collaborators

Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH-B007-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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