What is B007 studying for generalized myasthenia gravis?

B007 is being studied to evaluate its effectiveness and safety in treating generalized myasthenia gravis. The research aims to see if B007 can improve daily living activities and reduce symptoms compared to a placebo. This trial is sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd.

Who may be eligible for this generalized myasthenia gravis clinical trial?

Adults aged 18 to 70 with generalized myasthenia gravis who test positive for certain antibodies and are on stable standard treatment may qualify. Both males and females can participate, but females must agree to use contraception and have a negative pregnancy test. Please review eligibility criteria for more details.

Is there any cost to participate in this generalized myasthenia gravis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years - 70Years

All Genders

ID06447597

A Phase IIIII Randomized, Double-Blind Study of B007 Injections to Treat Generalized Myasthenia Gravis in Adults

Led by Shanghai Jiaolian Drug Research and Development Co., Ltd · Updated on 2026-04-30

104

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of B007 in people with generalized myasthenia gravis, a condition that causes muscle weakness. This randomized, double-blind, placebo-controlled Phase IIIII study aims to understand how well B007 works compared to a placebo in improving daily living activities affected by this condition. Participants will receive either a high or low dose of B007 or a matching placebo through subcutaneous injections on days 1 and 15. The study includes careful monitoring over approximately 16 to 24 weeks to assess changes in symptoms and quality of life, with a safety follow-up lasting about one year. During the trial, participants will be evaluated through various measures including the Myasthenia Gravis-Activities of Daily Living profile, quality of life questionnaires, and composite scores related to the condition. Researchers will also track any side effects or adverse events. The total participation time varies, with key assessments occurring around 16 to 24 weeks and safety monitored for about a year.

CONDITIONS

Brief Title

A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent form
Diagnosis of generalized myasthenia gravis
Positive for serum acetylcholine receptor antibody or MUSK antibody during screening
MG-ADL score of 5 or higher at screening and baseline
Stable dose of standard care treatment for generalized myasthenia gravis before randomization and throughout the study
Agreement to use effective contraception from consent signing to 1 year after last dose, including negative pregnancy test for fertile females before first dose

You will not qualify if you...

MGFA classification type I or V
Use of prescribed drugs that interfere with the study
Presence or history of other diseases that affect eligibility
Abnormal examination results assessed as unsuitable by the investigator
Known severe allergic reaction to humanized monoclonal antibodies or any component of B007
Receipt of live vaccines within specified times before or after dosing
Major surgery or participation in other clinical trials within specified times before screening
Pregnant or breastfeeding women
Fertile females unwilling to use contraception from consent to 1 year after last dose
Sexually active males unwilling to use contraception during the trial and 1 year after last dose or planning to donate sperm
History of alcohol or drug abuse within past 12 months
Other conditions deemed unsuitable by researchers

Research Team

Jianying Xi

Huan Yang

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