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

August 13, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiaolian Drug Research and Development Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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