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

Shanghai Jiaolian Drug Research and Development Co., Ltd2 sites in 1 country104 target enrollmentJuly 1, 2024

InterventionsB007 Placebo

Overview

Phase: Phase 2
Intervention: B007
Conditions: Generalized Myasthenia Gravis
Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Enrollment: 104
Locations: 2
Primary Endpoint: Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2
Status: Recruiting
Last Updated: last year

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

Registry

clinicaltrials.gov

Start Date

July 1, 2024

End Date

June 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Responsible Party

Sponsor

•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.

•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;
•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;

Intervention: B007

Intervention: Placebo

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

Proportion of subjects：subjects without SoC（Standard of Care） 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(Approximately 24 weeks)
Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.(Approximately 24 weeks)
Changes in MGC (Myasthenia gravis composite) from baseline.(Approximately 24 weeks)
Incidence of Treatment-Emergent Adverse Events(Approximately 1 years)