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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000969-21 | EudraCT Number |
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The purpose of the MycarinGstudy is to evaluate the long-term safety, tolerability and long-term efficacy of rozanolixizumab in study participants with generalized myasthenia gravis (MG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rozanolixizumab dosage regimen 1 | Experimental | Study participants randomized to dosage regimen 1 will receive assigned dosage of rozanolixizumab at pre-specified time points during the Treatment Period. The dose regimen may be switched based on investigator discretion. |
|
| Rozanolixizumab dosage regimen 2 | Experimental | Study participants randomized to dosage regimen 2 will receive assigned dosage of rozanolixizumab at pre-specified time points during the Treatment Period. The dose regimen may be switched based on investigator discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rozanolixizumab | Drug | Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | A TEAE is defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) or any unresolved event already present before the first administration of IMP that worsened in intensity following exposure to IMP, up to 8 weeks after the last dose of IMP in study participants who discontinued the study or IMP. | From Baseline until End of Study (up to Week 60) |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of Study Medication | A TEAE is defined as an AE starting on or after the time of first administration of IMP or any unresolved event already present before the first administration of IMP that worsened in intensity following exposure to IMP, up to 8 weeks after the last dose of IMP in study participants who discontinued the study or IMP. | From Baseline until End of Study (up to Week 60) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods | The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (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 positive change indicates worsening and a negative change indicates improvement. |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Mg0004 50081 | Phoenix | Arizona | 85013-4409 | United States | ||
| Mg0004 50072 |
| 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.
Participant Flow refers to the Randomized Set.
The study started to enroll study participants in Oct 2019 and concluded in Sep 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rozanolixizumab ~7 mg/kg | Participants received rozanolixizumab equivalent to approximately 7 milligrams/kilogram (mg/kg), subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60). |
| FG001 |
| 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 | Jul 30, 2020 | Aug 22, 2023 |
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|
| Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60 |
| Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods | MG-C scale is a validated assessment and scale tests 10 items with individual items being weighted differently. 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. Total MG-C score was obtained by summing responses to each individual item and score ranges from 0 to 50, with lower scores indicating lower disease activity. A positive change indicates worsening and a negative change indicates improvement. | Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60 |
| Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods | 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 indicates worsening and a negative change indicates improvement. | Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60 |
| Percentage of Participants Using Rescue Medication (Intravenous Infusion of Immunoglobulin G (IVIg) or Plasma Exchange (PEX)) | Rescue therapy consisted of IVIg or PEX. Study participants who experienced disease worsening (eg, an increase of 2 points on the MG-ADL or 3 points on the QMG scale between 2 consecutive visits) may be considered for rescue therapy at the discretion of the Investigator. | From Baseline until End of Study (up to Week 60) |
| Los Angeles |
| California |
| 90033 |
| United States |
| Mg0004 50088 | Washington D.C. | District of Columbia | 20037 | United States |
| Mg0004 50120 | Miami | Florida | 33144 | United States |
| Mg0004 50073 | Tampa | Florida | 33612 | United States |
| Mg0004 50114 | Indianapolis | Indiana | 46202 | United States |
| Mg0004 50121 | Lexington | Kentucky | 40536 | United States |
| Mg0004 50077 | New York | New York | 10021 | United States |
| Mg0004 50090 | Winston-Salem | North Carolina | 27157 | United States |
| Mg0004 50096 | Philadelphia | Pennsylvania | 19104 | United States |
| Mg0004 50066 | Montreal | Canada |
| Mg0004 50070 | Québec | Canada |
| Mg0004 50069 | Toronto | Canada |
| Mg0004 40125 | Ostrava-Poruba | Czechia |
| Mg0004 40124 | Prague | Czechia |
| Mg0004 40128 | Aalborg | Denmark |
| Mg0004 40129 | Bordeaux | France |
| Mg0004 40132 | Nice | France |
| Mg0004 40133 | Paris | France |
| Mg0004 40131 | Strasbourg | France |
| Mg0004 40140 | Göttingen | Germany |
| Mg0004 40078 | Leipzig | Germany |
| Mg0004 40177 | Münster | Germany |
| Mg0004 40144 | Milan | Italy |
| Mg0004 40146 | Pavia | Italy |
| Mg0004 40148 | Roma | Italy |
| Mg0004 40150 | Roma | Italy |
| Mg0004 20078 | Hanamaki Shi | Japan |
| Mg0004 20079 | Hiroshima | Japan |
| Mg0004 20077 | Miyagi | Japan |
| Mg0004 20076 | Shinjuku-Ku | Japan |
| Mg0004 20032 | Suita | Japan |
| Mg0004 40155 | Gdansk | Poland |
| Mg0004 40154 | Lodz | Poland |
| Mg0004 40151 | Lublin | Poland |
| Mg0004 20027 | Moscow | Russia |
| Mg0004 20001 | Saint Petersburg | Russia |
| Mg0004 20028 | Saint Petersburg | Russia |
| Mg0004 20055 | Saint Petersburg | Russia |
| Mg0004 40159 | Barcelona | Spain |
| Mg0004 40157 | L'Hospitalet de Llobregat | Spain |
| Mg0004 20080 | Taichung | Taiwan |
| Mg0004 20081 | 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. |
| Rozanolixizumab ~10 mg/kg |
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60). |
| Safety Set | Received at least 1 dose of investigational medicinal product |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Randomized Set (RS) which consisted of all study participants who were randomized, using the treatment assigned instead of the actual treatment received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rozanolixizumab ~7 mg/kg | Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60). |
| BG001 | Rozanolixizumab ~10 mg/kg | Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60). |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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) | A TEAE is defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) or any unresolved event already present before the first administration of IMP that worsened in intensity following exposure to IMP, up to 8 weeks after the last dose of IMP in study participants who discontinued the study or IMP. | The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP in this study. This endpoint was planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both rozanolixizumab (RLZ) doses. | Posted | Number | percentage of participants | From Baseline until End of Study (up to Week 60) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of Study Medication | A TEAE is defined as an AE starting on or after the time of first administration of IMP or any unresolved event already present before the first administration of IMP that worsened in intensity following exposure to IMP, up to 8 weeks after the last dose of IMP in study participants who discontinued the study or IMP. | The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP in this study. This endpoint was planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both rozanolixizumab doses. | Posted | Number | percentage of participants | From Baseline until End of Study (up to Week 60) |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods | The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (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 positive change indicates worsening and a negative change indicates improvement. | The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP in this study. Here, number analyzed signifies those participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods | MG-C scale is a validated assessment and scale tests 10 items with individual items being weighted differently. 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. Total MG-C score was obtained by summing responses to each individual item and score ranges from 0 to 50, with lower scores indicating lower disease activity. A positive change indicates worsening and a negative change indicates improvement. | The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP in this study. Here, number analyzed signifies those participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods | 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 indicates worsening and a negative change indicates improvement. | The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP in this study. Here, number analyzed signifies those participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Using Rescue Medication (Intravenous Infusion of Immunoglobulin G (IVIg) or Plasma Exchange (PEX)) | Rescue therapy consisted of IVIg or PEX. Study participants who experienced disease worsening (eg, an increase of 2 points on the MG-ADL or 3 points on the QMG scale between 2 consecutive visits) may be considered for rescue therapy at the discretion of the Investigator. | The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP in this study. | Posted | Number | percentage of participants | From Baseline until End of Study (up to Week 60) |
|
|
From Baseline until End of Study (up to Week 60)
TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. 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 | Rozanolixizumab ~7 mg/kg | Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60). | 0 | 50 | 7 | 50 | 27 | 50 |
| EG001 | Rozanolixizumab ~10 mg/kg | Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60). | 0 | 42 | 2 | 42 | 25 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Biopsy kidney abnormal | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2021 | Aug 22, 2023 | SAP_002.pdf |
| 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 years |
|
| Male |
|
| Black |
|
| White |
|
| Missing |
|
| Not Hispanic or Latino |
|
| Missing |
|
|
|
Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
|
|
| OG001 | Rozanolixizumab ~10 mg/kg | Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60). |
|
|
|
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| Participants |
|
|