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The purpose of the study is to assess the clinical efficacy of rozanolixizumab in adult Chinese participants with generalized myasthenia gravis (gMG) in the first Treatment Cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rozanolixizumab | Experimental | Participants will receive 6 dose per cycle of subcutaneous infusion of rozanolixizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozanolixizumab | Drug | Subcutaneous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score in the first Treatment Cycle | The total MG-ADL score is obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with a higher score indicating more disability. A positive change indicates worsening and a negative change indicates improvement. | Baseline to Day 43 (in first treatment cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| MG-ADL responder (≥2.0-point improvement from Baseline) at Day 43 in the first Treatment Cycle | A MG-ADL responder is defined as achieving at least 2.0-point improvement in the MG-ADL total score from Baseline. | Baseline to Day 43 (in first treatment cycle) |
| Change from Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) score within first 6 week treatment cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCB Cares | Contact | +18445992273 | ucbcares@ucb.com |
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 22733 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mg0033 20040 | Recruiting | Beijing | China | |||
| Mg0033 20261 |
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
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The MG-C scale is a validated assessment, with a higher score indicating more severe disease and a 3-point change being of clinical relevance. The scale tests 10 items, with individual items being weighted differently. The overall score ranges from 0 to 50 (more severe disease). The items included ptosis/upward gaze (range: 0 [>45 second] - 3 [Immediate]), double vision on lateral gaze (range: 0 [>45 second] - 4 [Immediate]), eye closure (range: 0 [Normal] - 2 [severe weakness]), talking (range: 0 [Normal] - 6 [difficult to understand speech]), chewing (range: 0 [Normal] - 6 [gastric tube]), swallowing (range: 0 [Normal] - 6 [gastric tube]), breathing (range: 0 [Normal] - 9 [ventilator dependence]), neck flexion (range: 0 [Normal] - 4 [severe weakness]), shoulder abduction (range: 0 [Normal] - 5 [severe weakness]) and hip flexion (range: 0 [Normal] - 5 [severe weakness]), lower scores= lower disease activity. |
| Baseline to Day 43 (in first treatment cycle) |
| Change from Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) score within first 6-week treatment cycle | The total QMG score is obtained by summing the responses to each individual item (13 items [ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity]; Responses: None=0, Mild=1, Moderate=2, Severe=3). The QMG is a validated assessment, with a higher score indicating more severe disease. Scoring for each item ranges from no weakness (0) to severe weakness (3), with an overall score range from 0 to 39. A 3-point change in the total score is considered clinically relevant. | Baseline to Day 43 (in first treatment cycle) |
| Change from Baseline to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' score within first 6-week treatment cycle | The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants will be asked to choose response option that best describes how frequently they experienced muscle weakness fatigability (items 34-42) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. | Baseline to Day 43 (in first treatment cycle) |
| Change from Baseline to Day 43 in MG Symptoms PRO 'Physical Fatigue' score within first 6-week treatment cycle | The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants will be asked to choose the response option that best describes how frequently they experienced physical fatigue (items 19-33) over the past 7 days using a 5-point Likert scale (1="none of the time" to 5="all of the time") for each item. | Baseline to Day 43 (in first treatment cycle) |
| Percentage of participants with treatment-emergent adverse events (TEAEs) | Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. | Up to End of study (40 weeks) |
| Percentage of participants with TEAEs leading to withdrawal of investigational medicinal product (IMP) | Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. | Up to End of study (40 weeks) |
| Recruiting |
| Changchun |
| China |
| Mg0033 20295 | Recruiting | Changsha | China |
| Mg0033 20348 | Recruiting | Fuzhou | China |
| Mg0033 20269 | Recruiting | Guangzhou | China |
| Mg0033 20185 | Recruiting | Jinan | China |
| Mg0033 20347 | Recruiting | Jinan | China |
| Mg0033 20172 | Recruiting | Shanghai | China |
| Mg0033 20184 | Recruiting | Shenzhen | China |
| Mg0033 20204 | Recruiting | Suzhou | China |
| Mg0033 20180 | Recruiting | Wuhan | China |
| Mg0033 20349 | Recruiting | Xuzhou SHI | China |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| C000627812 | rozanolixizumab |
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