BridgeMD
New treatment option for Generalized Myasthenia Gravis
Official title A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
ClinicalTrials.gov ID: NCT06447597
What this study is testing
What is B007?
B007 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for generalized myasthenia gravis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Sign informed consent form;
- people 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, people received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
You likely can't join if
- people with MGFA I and V type;
- people usingprescribed drugs;
- people with a prescribed disease or history of disease;
- The people 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;
- people 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...
See the full eligibility criteria
- Sign informed consent form;
- people 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, people received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
- people agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female people considered fertile by the investigator must have negative serum...
- people with MGFA I and V type;
- people usingprescribed drugs;
- people with a prescribed disease or history of disease;
- The people 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;
- people 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;
- people who have received major surgery or participated in other clinical trials within the prescribed time before screening;
- Pregnant and lactating women;
- Fertile female people do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
- Sexually active male people who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male people who plan to donate sperm during the trial or within 1...
- A history of alcohol or drug abuse within the past 12 months;
- Other conditions deemed unsuitable for participation in this study by the researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changchun, China
- Changsha, China
- Chengdu, China
- Guangzhou, China
- Hangzhou, China
- Jinan, China
- Kunming, China
- Nanchang, China
- Qingdao, China
- Shanghai, China
- Shenzhen, China
- Wuhan, China
- Xi'an, China
- Zunyi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changchun, China; Changsha, China; Chengdu, China; Guangzhou, China; Hangzhou, China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.