A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.
Recruiting
Phase 2
Phase 3
Interventional Study
Generalized Myasthenia Gravis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 104 (estimated)
- Sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd · Industry
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About This Trial
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Trial Locations
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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 So…
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