Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06447597
Other study ID # SPH-B007-303
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 30, 2024
Est. completion date June 30, 2026

Study information

Verified date June 2024
Source Shanghai Jiaolian Drug Research and Development Co., Ltd
Contact Jianying Xi
Phone 0086-021-52888045
Email hsyybwc@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 104
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
B007
B007 high dose and low dose: Subcutaneous injection was administered on days 1 and 15
Placebo
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15

Locations

Country Name City State
China Xiangya Hospital Central South University Changsha
China Huashan Hospital, Fudan University Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Jiaolian Drug Research and Development Co., Ltd Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects:MG-ADL(Myasthenia gravis-activities of daily living profile) decreased by =2 Proportion of subjects:MG-ADL decreased by =2 Approximately 16 weeks
Secondary 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 Approximately 24 weeks
Secondary 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 Approximately 24 weeks
Secondary Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline. Changes in MGQoL15r from baseline. Approximately 24 weeks
Secondary Changes in MGC (Myasthenia gravis composite) from baseline. Changes in MGC from baseline Approximately 24 weeks
Secondary Incidence of Treatment-Emergent Adverse Events Adverse event type, incidence, duration Approximately 1 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05514873 - An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors Phase 3
Completed NCT04124965 - A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Phase 3
Recruiting NCT04833894 - Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis Phase 2/Phase 3
Active, not recruiting NCT04963270 - A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis Phase 3
Active, not recruiting NCT02950155 - A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis Phase 3
Completed NCT03315130 - Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis Phase 2
Recruiting NCT05556096 - Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis Phase 3
Not yet recruiting NCT06392386 - A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis Phase 3
Not yet recruiting NCT06149559 - A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis Phase 2/Phase 3
Not yet recruiting NCT06193889 - A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Subjects With Refractory Generalized Myasthenia Gravis Phase 2
Completed NCT03920293 - Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis Phase 3
Completed NCT03770403 - A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness. Phase 3
Completed NCT03971422 - A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Phase 3
Recruiting NCT05403541 - Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis Phase 3
Recruiting NCT05644561 - Evaluation of Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, and Immunogenicity of Ravulizumab Administered Intravenously in Pediatric Participants With Generalized Myasthenia Gravis (gMG) Phase 3
Not yet recruiting NCT06456580 - A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG) Phase 3
Not yet recruiting NCT06463587 - Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) Phase 3
Recruiting NCT06055959 - A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis Phase 2/Phase 3
Completed NCT00515450 - Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis Phase 3
Recruiting NCT06064695 - Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis N/A