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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002247-28 | EudraCT Number |
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The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator |
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| Group 2 | Experimental |
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| Group 3 | Experimental |
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| Group 4 | Experimental |
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| Group 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M281 | Drug | M281 administered as IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE are defined as any AE occurring during or after the initiation of the first infusion of study drug. | Up to Day 113 |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. | Up to Day 113 |
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. For this study, any common terminology criteria for adverse events (CTCAE) Grade 3 or higher event of severe infection or hypoalbuminemia was considered as AESI. | Up to Day 113 |
| Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score | The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57 | Estimate of additional change from baseline in MG-ADL total score for every 10 percent (%) additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57. The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. |
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Participants must be ≥18 years of age with a documented history of Generalized Myasthenia Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, and no history of any neurologic disorder other than MG that might interfere with the accuracy of study assessments.
Additional, more specific criteria are defined in the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Momenta General Queries | Momenta Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Momenta Investigational Site | Phoenix | Arizona | 85013 | United States | ||
| Momenta Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38165333 | Derived | Antozzi C, Guptill J, Bril V, Gamez J, Meuth SG, Nowak RJ, Quan D, Sevilla T, Jouvin MH, Jin J, Karcher K, Ramchandren S, Sun H, Ling L, Zhu Y, Arroyo S; Vivacity-MG Phase 2 Study Group. Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis: Results From the Randomized Phase 2 Vivacity-MG Study. Neurology. 2024 Jan 23;102(2):e207937. doi: 10.1212/WNL.0000000000207937. Epub 2023 Dec 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57. |
| FG001 | Nipocalimab (M281) 5 Milligrams/Kilogram (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 | Aug 28, 2019 | Jun 22, 2021 |
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| Placebo | Other | Placebo administered as intravenous (IV) infusion |
|
| Baseline to Day 57 |
| Baseline and Day 57 |
| Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57 | Estimate of additional change from baseline in MG-ADL total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The MG-ADL was used to assess participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). Total score is sum of eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. | Baseline and Day 57 |
| Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57 | Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | Baseline and Day 57 |
| Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57 | Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | Baseline and Day 57 |
| Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57 | The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. | Day 57 |
| Change From Baseline in Total QMG Score at Day 57 | The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | Baseline and Day 57 |
| Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | Day 57 |
| Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57 | The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation. | Baseline and Day 57 |
| Change From Baseline in Total Serum IgG at Day 57 | Change from baseline in total serum IgG was reported. Blood samples were collected for analysis of total serum IgG. | Baseline and Day 57 |
| Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. | Baseline, Day 85 and Day 113 |
| Change From Baseline in Total QMG Score at Day 85 and Day 113 | The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | Baseline, Day 85 and Day 113 |
| Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation. | Baseline, Day 85 and Day 113 |
| Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III). | Baseline and Day 57 |
| Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III). | Baseline to Day 113 |
| Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Change from baseline in total serum IgG at Day 85 and Day 113 was analyzed. Blood samples were collected for analysis of total serum IgG. | Baseline, Day 85 and Day 113 |
| Serum Concentrations of Nipocalimab | Serum concentrations of nipocalimab were reported. Concentrations below the lowest quantifiable concentration (< LLOQ) that is <0.15 microgram/milliliter (mcg/mL) was treated as zero in calculating the summary statistics. | Baseline (Pre Infusion and Post Infusion), Day 15 (Pre Infusion), Day 29 (Pre Infusion), Day 43 (Pre Infusion), Day 57 (Pre Infusion and Post Infusion) and Day 85 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Momenta Investigational Site | Los Angeles | California | 90048 | United States |
| Momenta Investigational Site | Orange | California | 92868 | United States |
| Momenta Investigational Site | Stanford | California | 94305 | United States |
| Momenta Investigational Site | Aurora | Colorado | 80045 | United States |
| Momenta Investigational Site | New Haven | Connecticut | 06511 | United States |
| Momenta Investigational Site | Boca Raton | Florida | 33487 | United States |
| Momenta Investigational Site | Maitland | Florida | 32751 | United States |
| Momenta Investigational Site | Port Charlotte | Florida | 33952 | United States |
| Momenta Investigational Site | St. Petersburg | Florida | 33713 | United States |
| Momenta Investigational Site | Augusta | Georgia | 30912 | United States |
| Momenta Investigational Site | Meridian | Idaho | 83642 | United States |
| Momenta Investigational Site | Lake Barrington | Illinois | 60010 | United States |
| Momenta Investigational Site | Fairway | Kansas | 66205 | United States |
| Momenta Investigational Site | Boston | Massachusetts | 02114 | United States |
| Momenta Investigational Site | Boston | Massachusetts | 02115 | United States |
| Momenta Investigational Site | Boston | Massachusetts | 02215 | United States |
| Momenta Investigational Site | Detroit | Michigan | 48202 | United States |
| Momenta Investigational Site | East Lansing | Michigan | 48824 | United States |
| Momenta Investigational Site | Columbia | Missouri | 65212 | United States |
| Momenta Investigational Site | New Brunswick | New Jersey | 08550 | United States |
| Momenta Investigational Site | New York | New York | 10021 | United States |
| Momenta Investigational Site | Charlotte | North Carolina | 28207 | United States |
| Momenta Investigational Site | Durham | North Carolina | 27710 | United States |
| Momenta Investigational Site | Raleigh | North Carolina | 27607 | United States |
| Momenta Investigational Site | Cincinnati | Ohio | 45267 | United States |
| Momenta Investigational Site | Columbus | Ohio | 43210 | United States |
| Momenta Investigational Site | Cordova | Tennessee | 38106 | United States |
| Momenta Investigational Site | Austin | Texas | 78756 | United States |
| Momenta Investigational Site | Round Rock | Texas | 78681 | United States |
| Momenta Investigational Site | Leuven | Vlaams Brabant | 3000 | Belgium |
| Momenta Investigational Site | Antwerp | 2650 | Belgium |
| Momenta Investigational Site | Brussels | 1070 | Belgium |
| Momenta Investigational Site | Edmonton | Alberta | T6G 2G3 | Canada |
| Momenta Investigational Site | London | Ontario | N6A 5A5 | Canada |
| Momenta Investigational Site | Toronto | Ontario | M5G 2C4 | Canada |
| Momenta Investigational Site | Québec | Quebec | G1J 1Z4 | Canada |
| Momenta Investigational Site | Göttingen | Lower Saxony | 37075 | Germany |
| Momenta Investigational Site | Düsseldorf | 40225 | Germany |
| Momenta Investigational Site | Gummersbach | 51643 | Germany |
| Momenta Investigational Site | Münster | 48149 | Germany |
| Momenta Investigational Site | Cefalù | 90015 | Italy |
| Momenta Investigational Site | Messina | 98125 | Italy |
| Momenta Investigational Site | Milan | 20133 | Italy |
| Momenta Investigational Site | Krakow | 31-505 | Poland |
| Momenta Investigational Site | Lodz | 90-324 | Poland |
| Momenta Investigational Site | Warsaw | 01-684 | Poland |
| Momenta Investigational Site | Warsaw | 01-868 | Poland |
| Momenta Investigational Site | Barcelona | Catalan | 08035 | Spain |
| Momenta Investigational Site | Barcelona | Catalan | 08041 | Spain |
| Momenta Investigational Site | Badalona | Catalonia | 08036 | Spain |
| Momenta Investigational Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Momenta Investigational Site | Donostia / San Sebastian | Gipuzkoa | 20014 | Spain |
| Momenta Investigational Site | Madrid | 28007 | Spain |
| Momenta Investigational Site | Madrid | 28040 | Spain |
| Momenta Investigational Site | Seville | 41013 | Spain |
| Momenta Investigational Site | Valencia | 46026 | Spain |
| Momenta Investigational Site | Birmingham | B15 2TH | United Kingdom |
| Momenta Investigational Site | Sheffield | S11 9NE | United Kingdom |
| Momenta Investigational Site | Southampton | SO16 6YD | United Kingdom |
Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
| FG002 | Nipocalimab 30 mg/kg | Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43. |
| FG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| FG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57. |
| BG001 | Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43. |
| BG002 | Nipocalimab 30 mg/kg | Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43. |
| BG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| BG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE are defined as any AE occurring during or after the initiation of the first infusion of study drug. | The safety population included all participants who received any amount of nipocalimab or placebo. | Posted | Count of Participants | Participants | Up to Day 113 |
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| Primary | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. | The safety population included all participants who received any amount of nipocalimab or placebo. | Posted | Count of Participants | Participants | Up to Day 113 |
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| Primary | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. For this study, any common terminology criteria for adverse events (CTCAE) Grade 3 or higher event of severe infection or hypoalbuminemia was considered as AESI. | The safety population included all participants who received any amount of nipocalimab or placebo. | Posted | Count of Participants | Participants | Up to Day 113 |
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| Primary | Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score | The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. | Intent-to-Treat (ITT) population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this outcome measure (OM). | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 57 |
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| Secondary | Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57 | Estimate of additional change from baseline in MG-ADL total score for every 10 percent (%) additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57. The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. | All participants over all arms with both an MG-ADL score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates MG-ADL change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available. | Posted | Least Squares Mean | Standard Error | score on a scale per 10% IgG reduction | Baseline and Day 57 |
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| Secondary | Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57 | Estimate of additional change from baseline in MG-ADL total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The MG-ADL was used to assess participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). Total score is sum of eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. | All anti-AChR positive participants over all arms with both an MG-ADL score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates MG-ADL change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available. | Posted | Least Squares Mean | Standard Error | score on a scale per 10% IgG reduction | Baseline and Day 57 |
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| Secondary | Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57 | Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | All participants over all arms with both an QMG score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates QMG change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available. | Posted | Least Squares Mean | Standard Error | score on a scale per 10% IgG reduction | Baseline and Day 57 |
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| Secondary | Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57 | Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | All anti-AChR positive participants over all arms with both an QMG score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates QMG change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available. | Posted | Least Squares Mean | Standard Error | score on a scale per 10% IgG reduction | Baseline and Day 57 |
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| Secondary | Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57 | The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. | Population analyzed included ITT participants for whom data was available at Day 57. | Posted | Count of Participants | Participants | Day 57 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total QMG Score at Day 57 | The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 57 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | Population analyzed included ITT participants for whom data was available at Day 57. | Posted | Count of Participants | Participants | Day 57 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57 | The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation. | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 57 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Serum IgG at Day 57 | Change from baseline in total serum IgG was reported. Blood samples were collected for analysis of total serum IgG. | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | Posted | Mean | Standard Deviation | gram/liter (g/L) | Baseline and Day 57 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities. | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 85 and Day 113 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total QMG Score at Day 85 and Day 113 | The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment. | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 85 and Day 113 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation. | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 85 and Day 113 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III). | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | Posted | Count of Participants | Participants | Baseline and Day 57 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III). | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM. | Posted | Count of Participants | Participants | Baseline to Day 113 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Change from baseline in total serum IgG at Day 85 and Day 113 was analyzed. Blood samples were collected for analysis of total serum IgG. | ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | Posted | Mean | Standard Deviation | g/L | Baseline, Day 85 and Day 113 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentrations of Nipocalimab | Serum concentrations of nipocalimab were reported. Concentrations below the lowest quantifiable concentration (< LLOQ) that is <0.15 microgram/milliliter (mcg/mL) was treated as zero in calculating the summary statistics. | The safety population included all participants who received any amount of nipocalimab or placebo. Here 'n' (number analyzed) included the number of participants evaluated for specific timepoints. | Posted | Mean | Standard Deviation | micrograms/milliliter (mcg/mL) | Baseline (Pre Infusion and Post Infusion), Day 15 (Pre Infusion), Day 29 (Pre Infusion), Day 43 (Pre Infusion), Day 57 (Pre Infusion and Post Infusion) and Day 85 |
|
Up to Day 113
The safety population included all participants who received any amount of nipocalimab or placebo.
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 | Placebo | Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57. | 0 | 14 | 2 | 14 | 10 | 14 |
| EG001 | Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43. | 0 | 14 | 0 | 14 | 12 | 14 |
| EG002 | Nipocalimab 30 mg/kg | Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43. | 0 | 13 | 1 | 13 | 8 | 13 |
| EG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. | 0 | 13 | 0 | 13 | 12 | 13 |
| EG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. | 0 | 14 | 0 | 14 | 12 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Myasthenia Gravis | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Eye Pain | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Eyelid Ptosis | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Salivary Hypersecretion | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Feeling Cold | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Feeling Hot | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Infusion Site Pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vessel Puncture Site Pruritus | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vessel Puncture Site Swelling | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Asymptomatic Bacteriuria | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Muscle Rupture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Palate Injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bacterial Test | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Carbohydrate Antigen 19-9 Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Helicobacter Test Positive | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Liver Function Test Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neutrophil Count Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neutrophil Percentage Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urine Analysis Abnormal | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Glucose Tolerance Impaired | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Muscle Twitching | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Mononeuropathy | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Myasthenia Gravis | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tension Headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Skin Swelling | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Swelling Face | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Brachiocephalic Vein Thrombosis | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
Limitations to this study include the small sample sizes of each treatment arm and the study activity disruption due to the COVID-19 pandemic, especially the missed Quantitative Myasthenia Gravis (QMG) assessments which hampered the analysis of the endpoint.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DIRECTOR CLINICAL RESEARCH | Momenta Pharmaceuticals, Inc. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2020 | Jun 22, 2021 | 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
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| CANADA |
|
| GERMANY |
|
| ITALY |
|
| POLAND |
|
| SPAIN |
|
| UNITED KINGDOM |
|
| UNITED STATES |
|
Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43. |
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43. |
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
| OG002 | Nipocalimab 30 mg/kg | Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43. |
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
|
|
| OG002 | Nipocalimab 30 mg/kg | Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43. |
| OG003 | Nipocalimab 60 mg/kg | Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
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| Nipocalimab 60 mg/kg |
Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57. |
| OG004 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
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| OG003 | Nipocalimab 60 mg/kg (Q2W) | Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. |
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