NCT06447597 A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
| NCT ID | NCT06447597 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Shanghai Jiaolian Drug Research and Development Co., Ltd |
| Condition | Generalized Myasthenia Gravis |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 104 participants in total. It began in 2024-07-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06447597 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Generalized Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06447597 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06447597 currently recruiting?
Yes, NCT06447597 is actively recruiting participants. Contact the research team at hsyybwc@163.com for enrollment information.
Where is the NCT06447597 trial being conducted?
This trial is being conducted at Beijing, China, Changchun, China, Changsha, China, Chengdu, China and 11 additional locations.
Who is sponsoring the NCT06447597 clinical trial?
NCT06447597 is sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd. The trial plans to enroll 104 participants.