Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China
This is a multicenter, randomized, double-blind and placebo-controlled study. The investigational drug is HBM9161 injection, and the indication is MG. The subjects will be randomized to three dose groups (340mg, 680mg and placebo) for a 6 weeks' double-blind treatment period followed by an open-label extension treatment period. The study will investigate the safety, efficacy and pharmacodynamic and pharmacokinetic of HBM9161 in patients with attack of MG in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
HBM9161 Injection (680mg and 340mg)
Placebo, HBM9161 Injection (340mg)
HBM9161 Injection (340 mg)
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Day 43
The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe)
Time frame: 43 days
Change in the Myasthenia Gravis Composite (MGC) score from baseline to Day 43
The total QMG score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.
Time frame: 43 days
Change in the Quantitative Myasthenia Gravis (QMG) score from baseline to Day 43
The QMG test is a standardized quantitative strength scoring system and measures 13 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the QMG score. The QMG score can range from 0 (least severe) to 39 (most severe).
Time frame: 43 days
Change in the Myasthenia Gravis Quality of Life 15(MG-QoL15r) score from baseline to Day 43
The MG-QoL 15r scale is a patient-reported score that assesses the patient's perception of impairment and disability and the degree to which the patient tolerates disease manifestations. Each question was graded on a 3-point scale from 0=normal to 2=severe with a score of 0 to 30; the higher score indicates worse MG disease activity
Time frame: 43 days
Proportion of participants with a decrease on the MG-ADL Score by ≥ 2 points from baseline to Day 43
Time frame: 43 days
Proportion of participants with an improvement and worse on the MGFA Post-intervention Status (MGFA-PIS) from baseline to Day 43. o Improvement: MGC Score reduce ≥ 3 points o Aggravation: MGC Score increase ≥ 3 points
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Time frame: 43 days
Change in the MG-ADL score from baseline to Day 120
Time frame: 120 days
Change in the MGC score from baseline to Day 120
Time frame: 120 days
Change in the QMG score from baseline to Day 120
Time frame: 120 days
Change in the MG-QoL15r score from baseline to Day 120
Time frame: 120 days
Proportion of participants with persistent improvement on the MGC score from baseline to Day 120
Improvement (decrease) in the MGC score by ≥ 3 points for 6 weeks
Time frame: 120 days
Proportion of participants with persistent improvement on the MG-ADL score from baseline to Day 120
Improvement (decrease) in the MG-ADL Score by ≥ 2 points for 6 weeks
Time frame: 120 days