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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003230-20 | EudraCT Number |
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The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rozanolixizumab dosage regimen 1 | Experimental | Study participants randomized/assigned to dosage regimen 1 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion. |
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| Rozanolixizumab dosage regimen 2 | Experimental | Study participants randomized/assigned to dosage regimen 2 will receive assigned dosage of rozanolixizumab for the initial cycle. The dose regimen may be switched before the start of each subsequent treatment cycle based on investigator discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozanolixizumab | Drug | Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE was defined as any event that was not present prior to first dose of investigational medicinal product (IMP), or any unresolved event already present that worsened in intensity following treatment, up to 8 weeks after end of Treatment Period or after last dose of IMP in participants who discontinued study or IMP. | From Baseline (Day 1) to End of Study (up to 34 months) |
| Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (IMP) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to permanent withdrawal of study medication. | From Baseline (Day 1) to End of Study (up to 34 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The MG-ADL is an 8-item PRO instrument developed on basis of QMG. The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0= no symptoms or impaired performance and 3= most severe symptoms or impaired performance. The total score ranges from 0 to 24, with higher score indicating more disability. A positive change in score indicates worsening and negative change indicates improvement. For analyses done by study cycle, Baseline values were last available values prior to or on the same date of first administration of IMP at each cycle (Baseline [Day 1]) value for that cycle. |
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Inclusion Criteria:
Study participant must meet one of the following:
Body weight ≥35 kg at Baseline (Day 1)
Study participants may be male or female
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 22733 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mg0007 50092 | Orange | California | 92868 | United States | ||
| Mg0007 50099 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42388397 | Derived | Bril V, Druzdz A, Grosskreutz J, Habib AA, Mantegazza R, Sacconi S, Utsugisawa K, Vu T, Boehnlein M, Grimson F, Houston N, Kerbusch V, Pulido-Valdeolivas I, Tarancon T, Vissing J. Long-term use of rozanolixizumab in generalised myasthenia gravis: final pooled analysis of the phase III MycarinG study and two open-label extensions. Ther Adv Neurol Disord. 2026 Jun 29;19:17562864261458532. doi: 10.1177/17562864261458532. eCollection 2026. | |
| 40105996 |
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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 prespecified 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 study 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.
Participants who completed MG0003 (NCT03971422) or required rescue therapy during Observation Period (OP) in MG0003 (except for participants who received intravenous immunoglobulin/plasma exchange in MG0003) or completed at least 6 treatment visits in MG0004 (NCT04124965) were enrolled in this study.
The study started to enroll participants in February 2021 and concluded in January 2024. Participant Flow refers to Full Analysis Set (FAS).
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled, But Not Treated | Participants were enrolled but did not receive a treatment cycle of Rozanolixizumab (RLZ) in MG0007 per the Investigator's discretion. |
| FG001 | Rozanolixizumab ~7 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 3, 2022 | Jan 22, 2025 |
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| From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The QMG is a validated assessment and the scale tested 13 items, including ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3) and the score ranges from 0 to 39, with lower scores indicating lower disease activity. A positive change in the score indicates worsening and a negative change indicates improvement. For the analyses done by study cycle, Baseline values were the last available values prior to or on the same date (and same time if time was collected for the individual assessment) of first administration of IMP at each cycle (ie, Baseline [Day 1]) value for that cycle. | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3) | MG-C scale consists of 10 items which included ptosis (score range=0 to 3), double vision on lateral gaze left/right/both (score range=0 to 4), eye closure (score range=0 to 2), talking (score range=0 to 6), chewing (score range=0 to 6), swallowing (score range=0 to 6), breathing (score range=0 to 9), neck flexion or extension (score range=0 to 4), shoulder abduction (score range=0 to 5) and hip flexion (score range= 0 to 5), lower scores= lower disease activity. Total MG-C score obtained by summing responses to each individual item and score ranges from 0 - 50, (lower scores indicating lower disease activity). Positive change = worsening, and negative change = improvement. For analyses done by study cycle, Baseline values were last available values prior to or on the same date of first administration of IMP at each cycle (Baseline [Day 1]) value for that cycle. | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular symptoms (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Study participants had to choose response option that best described severity of ocular, bulbar, and respiratory symptoms over past 7 days using a 4-point Likert scale ("none" to "severe") and frequency of experiencing physical fatigue and muscle weakness fatigability over past 7 days using a 5-point Likert scale (1="none of the time" - 5= "all of the time"), for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicates more severe symptoms. For analyses done by study cycle, Baseline values were last available values prior to or on the same date of first administration of IMP at each cycle (Baseline [Day 1]) value for that cycle. | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Study participants had to choose response option based on frequency of experiencing physical fatigue (19-33) over past 7 days using a 5-point Likert scale (1="none of time" - 5="all of time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicated severe symptoms. | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar Muscle Weakness' Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Bulbar symptoms are now recognised as bulbar muscle weakness. Study participants were asked to choose response option that best described severity of bulbar muscle weakness (6-15) symptoms over past 7 days using a 4-point Likert scale (1="none" to 4="severe") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicated severe symptoms. | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| MG-ADL Responder Rate (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3 [Day 43]) | The MG-ADL is an 8-item PRO instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A MG-ADL responder was defined as achieving at least 2.0-point improvement (decrease) in the MG-ADL score from Baseline. | Day 43 of Cycle 1, 2, and 3 |
| Time to MG-ADL Response (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3) | Time to achieve MG-ADL response, defined as at least 2.0-point improvement from Baseline. Time to first MG-ADL response (in days) by study cycle was defined as date of first MG-ADL Response within study cycle - date of MG-ADL Baseline within study cycle + 1. | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| Time Between Consecutive Treatment Cycles | Time between consecutive treatment cycles: Study participants were assessed for MG worsening prior to repeated cycles. In case of symptom worsening (eg, an increase of 2.0 points on MG-ADL or 3.0 points on QMG scale) between assessments, resulted additional treatment, study participants undergone another 6-week treatment cycle followed by an Observation Period, based on Investigator's discretion. Time between treatment cycles was calculated as: date of first sc infusion in consecutive cycle - date of last sc infusion before new cycle + 1 (or date of censoring - date of last sc infusion before potential new cycle + 1). | From end of the 6-week treatment cycle (Day 43) to the next 6-week treatment cycle (Day 1), assessed up to 2.5 years |
| San Francisco |
| California |
| 94117 |
| United States |
| Mg0007 50122 | Miami | Florida | 33136 | United States |
| Mg0007 50120 | Miami | Florida | 33144 | United States |
| Mg0007 50073 | Tampa | Florida | 33612 | United States |
| Mg0007 50075 | Augusta | Georgia | 30912-0004 | United States |
| Mg0007 50323 | Honolulu | Hawaii | 96817 | United States |
| Mg0007 50114 | Indianapolis | Indiana | 46202 | United States |
| Mg0007 50121 | Lexington | Kentucky | 40536-0284 | United States |
| Mg0007 50077 | New York | New York | 10021 | United States |
| Mg0007 50090 | Winston-Salem | North Carolina | 27157 | United States |
| Mg0007 50096 | Philadelphia | Pennsylvania | 19104 | United States |
| Mg0007 50113 | Houston | Texas | 77030 | United States |
| Mg0007 50071 | Edmonton | Canada |
| Mg0007 50066 | Montreal | Canada |
| Mg0007 50124 | Montreal | Canada |
| Mg0007 50070 | Québec | Canada |
| Mg0007 50069 | Toronto | Canada |
| Mg0007 40125 | Ostrava - Poruba | Czechia |
| Mg0007 40124 | Prague | Czechia |
| Mg0007 40128 | Aalborg | Denmark |
| Mg0007 40127 | Aarhus | Denmark |
| Mg0007 40126 | Copenhagen | Denmark |
| Mg0007 40129 | Bordeaux | France |
| Mg0007 40360 | Limoges | France |
| Mg0007 40132 | Nice | France |
| Mg0007 40133 | Paris | France |
| Mg0007 40131 | Strasbourg | France |
| Mg0007 20160 | Tbilisi | Georgia |
| Mg0007 20161 | Tbilisi | Georgia |
| Mg0007 20163 | Tbilisi | Georgia |
| Mg0007 20164 | Tbilisi | Georgia |
| Mg0007 20165 | Tbilisi | Georgia |
| Mg0007 40134 | Essen | Germany |
| Mg0007 40140 | Göttingen | Germany |
| Mg0007 40139 | Jena | Germany |
| Mg0007 40078 | Leipzig | Germany |
| Mg0007 40177 | Münster | Germany |
| Mg0007 40283 | Bologna | Italy |
| Mg0007 40144 | Milan | Italy |
| Mg0007 40307 | Naples | Italy |
| Mg0007 40146 | Pavia | Italy |
| Mg0007 40148 | Roma | Italy |
| Mg0007 40150 | Roma | Italy |
| Mg0007 20035 | Bunkyō City | Japan |
| Mg0007 20068 | Chiba | Japan |
| Mg0007 20078 | Hanamaki-shi | Japan |
| Mg0007 20079 | Hiroshima | Japan |
| Mg0007 20075 | Kobe | Japan |
| Mg0007 20071 | Nagasaki | Japan |
| Mg0007 20077 | Sendai | Japan |
| Mg0007 20070 | Shinjuku-ku | Japan |
| Mg0007 20076 | Shinjuku-ku | Japan |
| Mg0007 20032 | Suita | Japan |
| Mg0007 40155 | Gdansk | Poland |
| Mg0007 40154 | Lodz | Poland |
| Mg0007 40151 | Lublin | Poland |
| Mg0007 40153 | Poznan | Poland |
| Mg0007 20169 | Novosibirsk | Russia |
| Mg0007 20001 | Saint Petersburg | Russia |
| Mg0007 20028 | Saint Petersburg | Russia |
| Mg0007 20055 | Saint Petersburg | Russia |
| Mg0007 40467 | Niš | Serbia |
| Mg0007 40160 | Barcelona | Spain |
| Mg0007 40157 | L'Hospitalet de Llobregat | Spain |
| Mg0007 40350 | Murcia | Spain |
| Mg0007 40308 | San Sebastián de los Reyes | Spain |
| Mg0007 20081 | Taipei | Taiwan |
| Mg0007 20086 | Taipei | Taiwan |
| Derived |
| Bril V, Druzdz A, Grosskreutz J, Habib AA, Kaminski HJ, Mantegazza R, Sacconi S, Utsugisawa K, Vu T, Boehnlein M, Gayfieva M, Greve B, Woltering F, Vissing J; MG0004 study investigators. Safety and efficacy of chronic weekly rozanolixizumab in generalized myasthenia gravis: the randomized open-label extension MG0004 study. J Neurol. 2025 Mar 19;272(4):275. doi: 10.1007/s00415-025-12958-9. |
| 37059507 | Derived | Bril V, Druzdz A, Grosskreutz J, Habib AA, Mantegazza R, Sacconi S, Utsugisawa K, Vissing J, Vu T, Boehnlein M, Bozorg A, Gayfieva M, Greve B, Woltering F, Kaminski HJ; MG0003 study team. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023 May;22(5):383-394. doi: 10.1016/S1474-4422(23)00077-7. |
Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
| FG002 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
| COMPLETED |
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| NOT COMPLETED |
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|
Baseline characteristics refers to the Full Analysis set (FAS) which consisted of all enrolled study participants who were randomized in this study or in MG0004.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled, But Not Treated | Participants were enrolled but did not receive a treatment cycle of Rozanolixizumab (RLZ) in MG0007 per the Investigator's discretion. |
| BG001 | Rozanolixizumab ~7 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
| BG002 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE was defined as any event that was not present prior to first dose of investigational medicinal product (IMP), or any unresolved event already present that worsened in intensity following treatment, up to 8 weeks after end of Treatment Period or after last dose of IMP in participants who discontinued study or IMP. | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Participants who switched doses were counted in both Rozanolixizumab (RLZ) doses. | Posted | Number | percentage of participants | From Baseline (Day 1) to End of Study (up to 34 months) |
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| Primary | Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (IMP) | An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to permanent withdrawal of study medication. | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Participants who switched doses were counted in both RLZ doses. | Posted | Number | percentage of participants | From Baseline (Day 1) to End of Study (up to 34 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The MG-ADL is an 8-item PRO instrument developed on basis of QMG. The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0= no symptoms or impaired performance and 3= most severe symptoms or impaired performance. The total score ranges from 0 to 24, with higher score indicating more disability. A positive change in score indicates worsening and negative change indicates improvement. For analyses done by study cycle, Baseline values were last available values prior to or on the same date of first administration of IMP at each cycle (Baseline [Day 1]) value for that cycle. | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed included those participants who were evaluable for the assessment. Number Analyzed included those participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The QMG is a validated assessment and the scale tested 13 items, including ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3) and the score ranges from 0 to 39, with lower scores indicating lower disease activity. A positive change in the score indicates worsening and a negative change indicates improvement. For the analyses done by study cycle, Baseline values were the last available values prior to or on the same date (and same time if time was collected for the individual assessment) of first administration of IMP at each cycle (ie, Baseline [Day 1]) value for that cycle. | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed included those participants who were evaluable for the assessment. Number Analyzed included those participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3) | MG-C scale consists of 10 items which included ptosis (score range=0 to 3), double vision on lateral gaze left/right/both (score range=0 to 4), eye closure (score range=0 to 2), talking (score range=0 to 6), chewing (score range=0 to 6), swallowing (score range=0 to 6), breathing (score range=0 to 9), neck flexion or extension (score range=0 to 4), shoulder abduction (score range=0 to 5) and hip flexion (score range= 0 to 5), lower scores= lower disease activity. Total MG-C score obtained by summing responses to each individual item and score ranges from 0 - 50, (lower scores indicating lower disease activity). Positive change = worsening, and negative change = improvement. For analyses done by study cycle, Baseline values were last available values prior to or on the same date of first administration of IMP at each cycle (Baseline [Day 1]) value for that cycle. | Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number of Participants Analyzed included participants who were evaluable for the assessment. Number Analyzed included participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
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| Secondary | Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular symptoms (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Study participants had to choose response option that best described severity of ocular, bulbar, and respiratory symptoms over past 7 days using a 4-point Likert scale ("none" to "severe") and frequency of experiencing physical fatigue and muscle weakness fatigability over past 7 days using a 5-point Likert scale (1="none of the time" - 5= "all of the time"), for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicates more severe symptoms. For analyses done by study cycle, Baseline values were last available values prior to or on the same date of first administration of IMP at each cycle (Baseline [Day 1]) value for that cycle. | Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number of Participants Analyzed: participants who were evaluable for the assessment. Number Analyzed: participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Study participants had to choose response option based on frequency of experiencing physical fatigue (19-33) over past 7 days using a 5-point Likert scale (1="none of time" - 5="all of time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicated severe symptoms. | Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number of Participants Analyzed: participants who were evaluable for the assessment. Number Analyzed: participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar Muscle Weakness' Score Within One Treatment Cycle (Cycle 1, 2, and 3) | The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Bulbar symptoms are now recognised as bulbar muscle weakness. Study participants were asked to choose response option that best described severity of bulbar muscle weakness (6-15) symptoms over past 7 days using a 4-point Likert scale (1="none" to 4="severe") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicated severe symptoms. | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed: participants who were evaluable for the assessment. Number Analyzed included those participants who were evaluable at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
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| Secondary | MG-ADL Responder Rate (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3 [Day 43]) | The MG-ADL is an 8-item PRO instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A MG-ADL responder was defined as achieving at least 2.0-point improvement (decrease) in the MG-ADL score from Baseline. | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed included those participants who were evaluable for the assessment. Number Analyzed: participants who were evaluable at specified timepoint. | Posted | Number | percentage of participants | Day 43 of Cycle 1, 2, and 3 |
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| Secondary | Time to MG-ADL Response (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3) | Time to achieve MG-ADL response, defined as at least 2.0-point improvement from Baseline. Time to first MG-ADL response (in days) by study cycle was defined as date of first MG-ADL Response within study cycle - date of MG-ADL Baseline within study cycle + 1. | Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number Analyzed: participants who were evaluable at specified timepoint. | Posted | Median | 95% Confidence Interval | days | From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3) |
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| Secondary | Time Between Consecutive Treatment Cycles | Time between consecutive treatment cycles: Study participants were assessed for MG worsening prior to repeated cycles. In case of symptom worsening (eg, an increase of 2.0 points on MG-ADL or 3.0 points on QMG scale) between assessments, resulted additional treatment, study participants undergone another 6-week treatment cycle followed by an Observation Period, based on Investigator's discretion. Time between treatment cycles was calculated as: date of first sc infusion in consecutive cycle - date of last sc infusion before new cycle + 1 (or date of censoring - date of last sc infusion before potential new cycle + 1). | Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number Analyzed: participants who were evaluable at specified timepoint. | Posted | Median | Full Range | days | From end of the 6-week treatment cycle (Day 43) to the next 6-week treatment cycle (Day 1), assessed up to 2.5 years |
|
Enrolled, but not treated: From Screening until End of Study (up to 34 months); Randomized participants: From Baseline (Day 1) until End of Study (up to 34 months)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with use of study medication, whether or not considered related to study medication. TEAEs were reported for all study participants in the FAS who received at least 1 dose of IMP. Eligible participants who did not undergo any treatment of RLZ but experienced an AE, are presented in a separate group "Enrolled but not treated". Participants who switched doses were counted in both RLZ doses.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled, But Not Treated | Participants were enrolled but did not receive a treatment cycle of Rozanolixizumab (RLZ) in MG0007 per the Investigator's discretion. | 1 | 8 | 3 | 8 | 5 | 8 |
| EG001 | Rozanolixizumab ~7 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. | 1 | 102 | 16 | 102 | 67 | 102 |
| EG002 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. | 3 | 102 | 31 | 102 | 78 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Adrenal disorder | Endocrine disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Oesophageal food impaction | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Sinusitis aspergillus | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Retroperitoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Prostate cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Myasthenia gravis crisis | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Subacute cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Thymectomy | Surgical and medical procedures | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Hepatic pain | General disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Streptococcal urinary tract infection | Infections and infestations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Interferon gamma release assay positive | Investigations | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA Version 24.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2024 | Jan 22, 2025 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627812 | rozanolixizumab |
Not provided
Not provided
Not provided
| 65 to <85 years |
|
| >=85 years |
|
| Male |
|
| Asian |
|
| Black |
|
| Native Hawaiian or other Pacific Islander |
|
| White |
|
| Other/mixed |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Missing |
|
| OG001 |
| Rozanolixizumab ~10 mg/kg |
Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion. |
|
|