Generalized Myasthenia Gravis
Conditions
Keywords
M281, Generalized Myasthenia Gravis
Brief summary
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.
Interventions
DRUGM281
M281 administered as IV infusion
OTHERPlacebo
Placebo administered as intravenous (IV) infusion
Sponsors
Momenta Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Up to Day 113 | 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. |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | Up to Day 113 | 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. |
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | Up to Day 113 | 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. |
| Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Change From Baseline in Total QMG Score at Day 57 | Baseline and 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. |
| Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 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. |
| Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57 | Baseline and 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. |
| Change From Baseline in Total Serum IgG at Day 57 | Baseline and Day 57 | Change from baseline in total serum IgG was reported. Blood samples were collected for analysis of total serum IgG. |
| Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Baseline, 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. |
| Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57 | Baseline and 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. |
| Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Baseline, 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. |
| Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Baseline and 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). |
| Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Baseline 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). |
| Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Baseline, 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. |
| Serum Concentrations of Nipocalimab | 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 | 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. |
| Change From Baseline in Total QMG Score at Day 85 and Day 113 | Baseline, 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. |
| 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 | Baseline and 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. |
| Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57 | Baseline and 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. |
| 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 | Baseline and 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. |
Countries
Belgium, Canada, Germany, Italy, Poland, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57. | 14 |
| 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. | 14 |
| 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. | 13 |
| 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. | 13 |
| Nipocalimab 60 mg/kg (Q2W) Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. | 14 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | COVID-19 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Nipocalimab 30 mg/kg | Nipocalimab 60 mg/kg | Nipocalimab 60 mg/kg (Q2W) | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 4 Participants | 4 Participants | 6 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 9 Participants | 9 Participants | 8 Participants | 43 Participants |
| Age, Continuous | 57.7 years STANDARD_DEVIATION 17.85 | 54.8 years STANDARD_DEVIATION 17.64 | 49 years STANDARD_DEVIATION 19.54 | 53.1 years STANDARD_DEVIATION 15.4 | 59.9 years STANDARD_DEVIATION 15.03 | 55 years STANDARD_DEVIATION 17.07 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 10 Participants | 13 Participants | 10 Participants | 11 Participants | 14 Participants | 58 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 12 Participants | 12 Participants | 12 Participants | 13 Participants | 14 Participants | 63 Participants |
| Region of Enrollment BELGIUM | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment CANADA | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants |
| Region of Enrollment GERMANY | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Region of Enrollment ITALY | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Region of Enrollment POLAND | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 8 Participants |
| Region of Enrollment SPAIN | 4 Participants | 0 Participants | 6 Participants | 2 Participants | 3 Participants | 15 Participants |
| Region of Enrollment UNITED KINGDOM | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment UNITED STATES | 3 Participants | 5 Participants | 4 Participants | 5 Participants | 8 Participants | 25 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 9 Participants | 9 Participants | 5 Participants | 37 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 4 Participants | 4 Participants | 9 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 13 | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 10 / 14 | 12 / 14 | 8 / 13 | 12 / 13 | 12 / 14 |
| serious Total, serious adverse events | 2 / 14 | 0 / 14 | 1 / 13 | 0 / 13 | 0 / 14 |
Outcome results
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.
Time frame: Baseline to Day 57
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score | -1.8 score on a scale | Standard Deviation 3.22 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score | -2.5 score on a scale | Standard Deviation 2.41 |
| Nipocalimab 30 mg/kg | Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score | -3.9 score on a scale | Standard Deviation 3 |
| Nipocalimab 60 mg/kg | Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score | -1.5 score on a scale | Standard Deviation 2.82 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score | -3.9 score on a scale | Standard Deviation 3.66 |
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.
Time frame: Up to Day 113
Population: The safety population included all participants who received any amount of nipocalimab or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | 0 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | 0 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | 0 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | 0 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | 0 Participants |
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.
Time frame: Up to Day 113
Population: The safety population included all participants who received any amount of nipocalimab or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 11 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 12 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 9 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 12 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 12 Participants |
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.
Time frame: Up to Day 113
Population: The safety population included all participants who received any amount of nipocalimab or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 2 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 0 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 1 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 0 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: Baseline and Day 57
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57 | -0.30 score on a scale per 10% IgG reduction | Standard Error 0.136 |
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.
Time frame: Baseline and Day 57
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | -0.33 score on a scale per 10% IgG reduction | Standard Error 0.144 |
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.
Time frame: Baseline, Day 85 and Day 113
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 85 | -2.2 score on a scale | Standard Deviation 2.64 |
| Placebo | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 113 | -2.6 score on a scale | Standard Deviation 3.09 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 85 | -2.1 score on a scale | Standard Deviation 2.4 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 113 | -1.0 score on a scale | Standard Deviation 2.25 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 85 | -3.7 score on a scale | Standard Deviation 2.69 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 113 | -2.8 score on a scale | Standard Deviation 2.33 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 113 | -2.4 score on a scale | Standard Deviation 2.78 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 85 | -1.9 score on a scale | Standard Deviation 2.29 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 85 | -3.6 score on a scale | Standard Deviation 2.79 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 | Day 113 | -2.6 score on a scale | Standard Deviation 3.3 |
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.
Time frame: Baseline, Day 85 and Day 113
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 85 | -2.5 score on a scale | Standard Deviation 2.84 |
| Placebo | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 113 | -3.2 score on a scale | Standard Deviation 3.9 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 85 | -2.9 score on a scale | Standard Deviation 3.74 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 113 | -1.6 score on a scale | Standard Deviation 4.2 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 85 | -6.5 score on a scale | Standard Deviation 5.66 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 113 | -4.2 score on a scale | Standard Deviation 4.32 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 113 | -1.0 score on a scale | Standard Deviation 2.92 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 85 | -0.7 score on a scale | Standard Deviation 4.25 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 85 | -3.5 score on a scale | Standard Deviation 5.61 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 | Day 113 | -2.5 score on a scale | Standard Deviation 6.09 |
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.
Time frame: Baseline and Day 57
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | -0.45 score on a scale per 10% IgG reduction | Standard Error 0.181 |
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.
Time frame: Baseline and Day 57
Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Total QMG Score at Day 57 | -3.7 score on a scale | Standard Deviation 2.94 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total QMG Score at Day 57 | -3.5 score on a scale | Standard Deviation 4.1 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total QMG Score at Day 57 | -4.1 score on a scale | Standard Deviation 3.45 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total QMG Score at Day 57 | -1.5 score on a scale | Standard Deviation 2.54 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total QMG Score at Day 57 | -5.9 score on a scale | Standard Deviation 5.3 |
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.
Time frame: Baseline, Day 85 and Day 113
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 85 | -4.0 score on a scale | Standard Deviation 2.62 |
| Placebo | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 113 | -4.7 score on a scale | Standard Deviation 3.04 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 85 | -3.6 score on a scale | Standard Deviation 3.23 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 113 | -2.1 score on a scale | Standard Deviation 2.4 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 85 | -4.8 score on a scale | Standard Deviation 2.49 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 113 | -4.2 score on a scale | Standard Deviation 3.08 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 113 | -3.2 score on a scale | Standard Deviation 2.28 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 85 | -2.0 score on a scale | Standard Deviation 2.6 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 85 | -5.1 score on a scale | Standard Deviation 3.52 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total QMG Score at Day 85 and Day 113 | Day 113 | -3.3 score on a scale | Standard Deviation 5.69 |
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.
Time frame: Baseline and Day 57
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57 | -0.38 score on a scale per 10% IgG reduction | Standard Error 0.174 |
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.
Time frame: Baseline and Day 57
Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57 | -2.0 score on a scale | Standard Deviation 4.58 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57 | -1.7 score on a scale | Standard Deviation 4.16 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57 | -6.8 score on a scale | Standard Deviation 5.73 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57 | -1.2 score on a scale | Standard Deviation 1.91 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57 | -3.7 score on a scale | Standard Deviation 5.37 |
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.
Time frame: Baseline and Day 57
Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Total Serum IgG at Day 57 | -0.3 gram/liter (g/L) | Standard Deviation 1.82 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total Serum IgG at Day 57 | -1.5 gram/liter (g/L) | Standard Deviation 1.01 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total Serum IgG at Day 57 | -3.4 gram/liter (g/L) | Standard Deviation 1.01 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total Serum IgG at Day 57 | -1.7 gram/liter (g/L) | Standard Deviation 1.23 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total Serum IgG at Day 57 | -7.6 gram/liter (g/L) | Standard Deviation 2.27 |
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.
Time frame: Baseline, Day 85 and Day 113
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 85 | -0.5 g/L | Standard Deviation 1.02 |
| Placebo | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 113 | -0.6 g/L | Standard Deviation 1.19 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 85 | -1.4 g/L | Standard Deviation 1.93 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 113 | -0.7 g/L | Standard Deviation 1.48 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 85 | -3.8 g/L | Standard Deviation 1.28 |
| Nipocalimab 30 mg/kg | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 113 | -1.2 g/L | Standard Deviation 0.78 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 113 | -0.7 g/L | Standard Deviation 1.09 |
| Nipocalimab 60 mg/kg | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 85 | -1.2 g/L | Standard Deviation 1.02 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 85 | -5.7 g/L | Standard Deviation 2.3 |
| Nipocalimab 60 mg/kg (Q2W) | Change From Baseline in Total Serum IgG at Day 85 and Day 113 | Day 113 | -2.2 g/L | Standard Deviation 1.73 |
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.
Time frame: Day 57
Population: Population analyzed included ITT participants for whom data was available at Day 57.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 | 2-point Improved | 7 Participants |
| Placebo | 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 | >=8-point Improved | 1 Participants |
| Placebo | 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 | 7-point Improved | 1 Participants |
| Placebo | 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 | 4-point Improved | 1 Participants |
| Placebo | 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 | 3-point Improved | 5 Participants |
| Placebo | 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 | 5-point Improved | 1 Participants |
| Placebo | 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 | 6-point Improved | 1 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | 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 | 6-point Improved | 1 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | 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 | 5-point Improved | 2 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | 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 | 3-point Improved | 9 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | 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 | 2-point Improved | 9 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | 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 | 7-point Improved | 1 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | 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 | 4-point Improved | 5 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | 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 | >=8-point Improved | 0 Participants |
| Nipocalimab 30 mg/kg | 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 | 5-point Improved | 5 Participants |
| Nipocalimab 30 mg/kg | 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 | 2-point Improved | 10 Participants |
| Nipocalimab 30 mg/kg | 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 | 3-point Improved | 8 Participants |
| Nipocalimab 30 mg/kg | 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 | 4-point Improved | 5 Participants |
| Nipocalimab 30 mg/kg | 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 | 6-point Improved | 3 Participants |
| Nipocalimab 30 mg/kg | 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 | 7-point Improved | 3 Participants |
| Nipocalimab 30 mg/kg | 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 | >=8-point Improved | 1 Participants |
| Nipocalimab 60 mg/kg | 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 | 4-point Improved | 3 Participants |
| Nipocalimab 60 mg/kg | 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 | 6-point Improved | 1 Participants |
| Nipocalimab 60 mg/kg | 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 | 3-point Improved | 5 Participants |
| Nipocalimab 60 mg/kg | 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 | >=8-point Improved | 0 Participants |
| Nipocalimab 60 mg/kg | 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 | 7-point Improved | 0 Participants |
| Nipocalimab 60 mg/kg | 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 | 2-point Improved | 7 Participants |
| Nipocalimab 60 mg/kg | 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 | 5-point Improved | 2 Participants |
| Nipocalimab 60 mg/kg (Q2W) | 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 | 4-point Improved | 7 Participants |
| Nipocalimab 60 mg/kg (Q2W) | 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 | >=8-point Improved | 2 Participants |
| Nipocalimab 60 mg/kg (Q2W) | 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 | 7-point Improved | 2 Participants |
| Nipocalimab 60 mg/kg (Q2W) | 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 | 6-point Improved | 3 Participants |
| Nipocalimab 60 mg/kg (Q2W) | 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 | 3-point Improved | 11 Participants |
| Nipocalimab 60 mg/kg (Q2W) | 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 | 2-point Improved | 12 Participants |
| Nipocalimab 60 mg/kg (Q2W) | 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 | 5-point Improved | 6 Participants |
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.
Time frame: Day 57
Population: Population analyzed included ITT participants for whom data was available at Day 57.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 3-point Improved | 8 Participants |
| Placebo | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 4-point Improved | 5 Participants |
| Placebo | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 5-point Improved | 5 Participants |
| Placebo | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 6-point Improved | 2 Participants |
| Placebo | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 7-point Improved | 2 Participants |
| Placebo | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | >= 8-point Improved | 2 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 7-point Improved | 5 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | >= 8-point Improved | 3 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 3-point Improved | 6 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 5-point Improved | 5 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 6-point Improved | 5 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 4-point Improved | 5 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 6-point Improved | 4 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 7-point Improved | 1 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 3-point Improved | 6 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 5-point Improved | 5 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 4-point Improved | 6 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | >= 8-point Improved | 1 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 6-point Improved | 1 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 4-point Improved | 3 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 5-point Improved | 1 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | >= 8-point Improved | 0 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 7-point Improved | 0 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 3-point Improved | 4 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 7-point Improved | 3 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 5-point Improved | 8 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 4-point Improved | 10 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | >= 8-point Improved | 3 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 6-point Improved | 5 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 | 3-point Improved | 10 Participants |
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).
Time frame: Baseline to Day 113
Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Improved | 3 Participants |
| Placebo | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Worsened | 0 Participants |
| Placebo | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Same | 6 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Same | 5 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Improved | 2 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Worsened | 2 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Same | 4 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Improved | 3 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Worsened | 1 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Improved | 2 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Worsened | 0 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Same | 5 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Same | 5 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Improved | 3 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With Shift From Baseline in MGFA Classification to Day 113 | Worsened | 3 Participants |
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).
Time frame: Baseline and Day 57
Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Improved | 6 Participants |
| Placebo | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Worsened | 0 Participants |
| Placebo | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Same | 6 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Same | 9 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Improved | 3 Participants |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Worsened | 0 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Same | 3 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Improved | 7 Participants |
| Nipocalimab 30 mg/kg | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Worsened | 1 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Improved | 4 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Worsened | 0 Participants |
| Nipocalimab 60 mg/kg | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Same | 8 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Same | 4 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Improved | 7 Participants |
| Nipocalimab 60 mg/kg (Q2W) | Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 | Worsened | 1 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Concentrations of Nipocalimab | Baseline (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0.005 |
| Placebo | Serum Concentrations of Nipocalimab | Baseline (Post Infusion) | 117.75 micrograms/milliliter (mcg/mL) | Standard Deviation 84.835 |
| Placebo | Serum Concentrations of Nipocalimab | Day 15 (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0.006 |
| Placebo | Serum Concentrations of Nipocalimab | Day 29 (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0.004 |
| Placebo | Serum Concentrations of Nipocalimab | Day 43 (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0.004 |
| Placebo | Serum Concentrations of Nipocalimab | Day 57 (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0.006 |
| Placebo | Serum Concentrations of Nipocalimab | Day 57 (Post Infusion) | 49.15 micrograms/milliliter (mcg/mL) | Standard Deviation 41.507 |
| Placebo | Serum Concentrations of Nipocalimab | Day 85 | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0.007 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Serum Concentrations of Nipocalimab | Day 57 (Pre Infusion) | 95.40 micrograms/milliliter (mcg/mL) | Standard Deviation 301.681 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Serum Concentrations of Nipocalimab | Day 43 (Pre Infusion) | 0.01 micrograms/milliliter (mcg/mL) | Standard Deviation 0.013 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Serum Concentrations of Nipocalimab | Baseline (Post Infusion) | 746.80 micrograms/milliliter (mcg/mL) | Standard Deviation 47.214 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Serum Concentrations of Nipocalimab | Day 85 | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Serum Concentrations of Nipocalimab | Day 57 (Post Infusion) | 746.50 micrograms/milliliter (mcg/mL) | Standard Deviation 96.874 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Serum Concentrations of Nipocalimab | Day 29 (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Serum Concentrations of Nipocalimab | Day 15 (Pre Infusion) | 0.01 micrograms/milliliter (mcg/mL) | Standard Deviation 0.01 |
| Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Serum Concentrations of Nipocalimab | Baseline (Pre Infusion) | 0.00 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 30 mg/kg | Serum Concentrations of Nipocalimab | Day 57 (Post Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 30 mg/kg | Serum Concentrations of Nipocalimab | Day 15 (Pre Infusion) | 27.61 micrograms/milliliter (mcg/mL) | Standard Deviation 42.167 |
| Nipocalimab 30 mg/kg | Serum Concentrations of Nipocalimab | Day 29 (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 30 mg/kg | Serum Concentrations of Nipocalimab | Day 43 (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 30 mg/kg | Serum Concentrations of Nipocalimab | Day 57 (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 30 mg/kg | Serum Concentrations of Nipocalimab | Day 85 | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 30 mg/kg | Serum Concentrations of Nipocalimab | Baseline (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 30 mg/kg | Serum Concentrations of Nipocalimab | Baseline (Post Infusion) | 1847.50 micrograms/milliliter (mcg/mL) | Standard Deviation 153.27 |
| Nipocalimab 60 mg/kg | Serum Concentrations of Nipocalimab | Day 15 (Pre Infusion) | 29.30 micrograms/milliliter (mcg/mL) | Standard Deviation 36.631 |
| Nipocalimab 60 mg/kg | Serum Concentrations of Nipocalimab | Day 29 (Pre Infusion) | 72.69 micrograms/milliliter (mcg/mL) | Standard Deviation 152.058 |
| Nipocalimab 60 mg/kg | Serum Concentrations of Nipocalimab | Baseline (Post Infusion) | 1325.00 micrograms/milliliter (mcg/mL) | Standard Deviation 616.443 |
| Nipocalimab 60 mg/kg | Serum Concentrations of Nipocalimab | Baseline (Pre Infusion) | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0 |
| Nipocalimab 60 mg/kg | Serum Concentrations of Nipocalimab | Day 43 (Pre Infusion) | 66.72 micrograms/milliliter (mcg/mL) | Standard Deviation 85.919 |
| Nipocalimab 60 mg/kg | Serum Concentrations of Nipocalimab | Day 85 | 0.0 micrograms/milliliter (mcg/mL) | Standard Deviation 0.004 |
| Nipocalimab 60 mg/kg | Serum Concentrations of Nipocalimab | Day 57 (Post Infusion) | 1827.50 micrograms/milliliter (mcg/mL) | Standard Deviation 741.052 |
| Nipocalimab 60 mg/kg | Serum Concentrations of Nipocalimab | Day 57 (Pre Infusion) | 44.80 micrograms/milliliter (mcg/mL) | Standard Deviation 68.56 |