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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBM9161 (680mg and 340 mg) | Experimental | Subcutaneous injection; Blinded: HBM9161 680mg; Open-label: HBM9161 340mg; |
|
| HBM9161 (340 mg) | Experimental | Subcutaneous injection; Blinded: HBM9161 340mg; Open-label: HBM9161 340mg; |
|
| Placebo, HBM9161 (340 mg) | Placebo Comparator | Subcutaneous injection; Blinded: Placebo; Open-label: HBM9161 340mg; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBM9161 Injection (680mg and 340 mg) | Drug | HBM9161 Injection (680mg and 340mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 43 days |
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Inclusion Criteria:
Signed Informed Consent Form.
Male or female ≥ 18 years of age.
A female participant is eligible to participate if she is of:
A male participant must take effective contraception during this clinical trial or their heterosexual partner must take effective contraception.
Meets MGFA myasthenia gravis clinical classification IIa-IVa (includes types IIa, IIb, IIIa, IIIb, and IVa) at the screening visit and at the baseline visit.
Screening and baseline MG-ADL score ≥ 6, and < 50% of them is from ocular muscle.
Stable background MG treatments at randomization.
Positive serologic test for AChR-Ab or MUSK-Ab at the screening visit and at least 1 of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chongbo Zhao | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35412216 | Derived | Yan C, Duan RS, Yang H, Li HF, Zou Z, Zhang H, Zhou H, Li XL, Zhou H, Jiao L, Chen J, Yin J, Du Q, Lee M, Chen Y, Chen X, Zhao C. Therapeutic Effects of Batoclimab in Chinese Patients with Generalized Myasthenia Gravis: A Double-Blinded, Randomized, Placebo-Controlled Phase II Study. Neurol Ther. 2022 Jun;11(2):815-834. doi: 10.1007/s40120-022-00345-9. Epub 2022 Apr 12. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2020 | Jul 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000722910 | HBM9161 |
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for double-blind period
| Placebos | Drug | Placebo, HBM9161 Injection (340mg) |
|
| HBM9161 Injection (340 mg) | Drug | HBM9161 Injection (340 mg) |
|
| 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). |
| 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 | 43 days |
| Proportion of participants with a decrease on the MG-ADL Score by ≥ 2 points from baseline to Day 43 | 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 | 43 days |
| Change in the MG-ADL score from baseline to Day 120 | 120 days |
| Change in the MGC score from baseline to Day 120 | 120 days |
| Change in the QMG score from baseline to Day 120 | 120 days |
| Change in the MG-QoL15r score from baseline to Day 120 | 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 | 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 | 120 days |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |