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

Sponsor
Shanghai Jiaolian Drug Research and Development Co., Ltd
Study ID
NCT06447597
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Jun 7, 2024
Start date
Jul 1, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: B007
  • Placebo Comparator: Placebo

Primary Outcome Measure

Proportion of subjects：MG-ADL（Myasthenia gravis-activities of daily living profile） decreased by ≥2 [ Time Frame: Approximately 16 weeks ]

Central Contacts

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