Generalized Myasthenia GravisPhase 2/3NCT06447597
A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
A Phase 2/3 study testing B007 in people with Generalized Myasthenia Gravis, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 18 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- B007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 18 sitesChina
- Study dates
- 1 Jul 2024to 30 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent form;
- Subjects with generalized myasthenia gravis;
- Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
- MG-ADL ≥5 at screening and baseline;
- Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
- 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.
Who cannot join
- Subjects with MGFA I and V type;
- Subjects usingprescribed drugs;
- Subjects with a prescribed disease or history of disease;
- The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
- Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
- 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;
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- Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
- Pregnant and lactating women;
- Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
- 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;
- A history of alcohol or drug abuse within the past 12 months;
- Other conditions deemed unsuitable for participation in this study by the researchers.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Peking University First Hospital
Beijing
Feng Gao
- Recruiting
The First Bethune Hospital of Jilin University
Changchun
Hui Deng
- Recruiting
Xiangya Hospital Central South University
Changsha
Huan yang
- Recruiting
Sichuan Provincial People's Hospital
Chengdu
Fei Xu
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou
Haishan Jiang
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Qing Ke
- Recruiting
Shandong Provincial Qianfoshan Hospital
Jinan
Ruisheng Duan
- Recruiting
Shandong University Cheeloo College of Medicine
Jinan
Wei Li
- Recruiting
First People's Hospital of Yunnan Province
Kunming
Qiang Meng
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang
Rensi Xu
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
Jianglong Tu
- Recruiting
Shandong University Cheeloo College of Medicine
Qingdao
Cuiping Zhao
- Recruiting
Huashan Hospital, Fudan University
Shanghai
jianying Xi
- Recruiting
Shenzhen Hospital of University of Hong Kong
Shenzhen
Haibing Xiao
- Recruiting
Renmin Hospital of Wuhan University
Wuhan
Zuneng Lu
- Recruiting
Tongji Medical College of HUST
Wuhan
Bitao Bu
- Recruiting
Tangdu Hospital
Xi'an
Ting Chang
- Recruiting
Affiliated Hospital of Zunyi Medical College
Zunyi
Zucai Xu
About this study
Official title: 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.
- Conditions
- Generalized Myasthenia Gravis
- Being tested
- B007, Placebo
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B007Drug
B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15
PlaceboDrug
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| B007 | Experimental | Not described Receives: Drug: B007 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2
Proportion of subjects：MG-ADL decreased by ≥2
Measured: Approximately 16 weeks
Secondary outcomes (5)
Proportion of subjects：subjects without SoC（Standard of Care） change and MG-ADL decreased by ≥2
Proportion of subjects：subjects without SoC change and MG-ADL decreased by ≥2
Measured: Approximately 24 weeks
Proportion of subjects：subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3
Proportion of subjects：subjects without SoC change and QMG decreased by ≥3
Measured: Approximately 24 weeks
Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.
Changes in MGQoL15r from baseline.
Measured: Approximately 24 weeks
Changes in MGC (Myasthenia gravis composite) from baseline.
Changes in MGC from baseline
Measured: Approximately 24 weeks
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Measured: Approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jul 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447597
- Sponsor's protocol ID
- SPH-B007-303
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06447597
- Acronym / sponsor ID
- SPH-B007-303
- Conditions
- Generalized Myasthenia Gravis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B007 | Experimental | Drug: B007 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign informed consent form;
- Subjects with generalized myasthenia gravis;
- Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
- MG-ADL ≥5 at screening and baseline;
- Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
Key exclusion criteria (12 listed)
- Subjects with MGFA I and V type;
- Subjects usingprescribed drugs;
- Subjects with a prescribed disease or history of disease;
- The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
- Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B007B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15 | Drug | B007 |
| PlaceboB007 matched Placebo Subcutaneous injection was administered on days 1 and 15 | Drug | Placebo |
Primary outcome
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
5 secondary outcomes
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 QMG(Quantitative Myasthenia Gravis score) decreased by ≥3
Time frame: Approximately 24 weeks
Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.
Time frame: Approximately 24 weeks
Changes in MGC (Myasthenia gravis composite) from baseline.
Time frame: Approximately 24 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing B007 in people with Generalized Myasthenia Gravis, run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianying Xi (0086-021-52888045, hsyybwc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2 (time frame: Approximately 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.