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This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of SHR-2173 compared to placebo as an add-on therapy to standard of care (SOC) for the treatment of generalized myasthenia gravis (gMG). The study consists of a 4-week screening period, a 24-week treatment period, and a 12-week safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR-2173 injection | Experimental |
| |
| Treatment group B: SHR-2173 injection | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2173 injection | Drug | SHR-2173 injection;High dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MG-ADL total score | at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Quantitative Myasthenia Gravis (QMG) score | at Week 24 | |
| Change from baseline in Myasthenia Gravis Composite (MGC) total score | at Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
Presence of any of the following medical histories or comorbidities:
Use of any of the following drugs/treatments or participation in a clinical study:
A history of malignancy within 5 years prior to screening;
Infection-related medical history and examinations:
General situation:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kunming Li | Contact | 0518-82342973 | kunming.li@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
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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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| SHR-2173 injection |
| Drug |
SHR-2173 injection;Low dose |
|
| Placebo | Drug | Placebo |
|
| Change from baseline in MG-ADL domain scores (ocular, bulbar, respiratory, limb) |
| at Week 24 |
| Change from baseline in QMG domain scores (ocular, bulbar, respiratory, limb) | at Week 24 |
| Proportion of participants with ≥3-point reduction from baseline in MG-ADL total score | at Week 24 |
| Proportion of participants with ≥50% reduction from baseline in MG-ADL total score | at Week 24 |
| Proportion of participants with ≥5-point reduction from baseline in QMG score | at Week 24 |
| Proportion of participants achieving Minimal Symptom Expression (MSE; MG-ADL total score 0 or 1) at Week 24 | at Week 24 |
| Change from baseline in Myasthenia Gravis Quality of Life 15-item revised (MG-QoL15r) total score | at Week 24 |
| Change from baseline in Neuro-QoL Fatigue subscale score | at Week 24 |
| Change from baseline in European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) index score | at Week 24 |
| Proportion of participants without rescue therapy | through Week 24 |
| Incidence, severity grading, and drug-relatedness of adverse events (AEs) | through Week 24 |
| Incidence, severity grading, and drug-relatedness of serious adverse events (SAEs) | through Week 24 |
| Incidence, severity grading, and drug-relatedness of adverse events of special interest (AESIs) | through Week 24 |
| Change from baseline in C-SSRS | through Week 24 |
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
|
| 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 |