Trial Outcomes & Findings for An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis (NCT NCT03896295)

NCT ID: NCT03896295

Last Updated: 2023-06-27

Results Overview

Number of participants with TEAEs were reported. 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. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug in this study.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: Up to 257 days post-baseline (Baseline is Day 1)
• Results posted on: 2023-06-27

Participant Flow

Participants from study MOM-M281-004 (NCT03772587) who completed the Day 113 visit of that study were eligible to enroll in this open-label extension study (MOM-M281-005). The Day 113 visit of MOM-M281-004 occurred approximately 8 weeks after the last dose in that study.

Participant milestones

Measure	Placebo-Nipocalimab Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Overall Study STARTED	7	30
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	30

Reasons for withdrawal

Measure	Placebo-Nipocalimab Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Overall Study Adverse Event	0	1
Overall Study COVID-19	7	29

Baseline Characteristics

An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis

Baseline characteristics by cohort

Measure	Placebo-Nipocalimab n=7 Participants Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants	20 Participants n=4 Participants	25 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	10 Participants n=4 Participants	12 Participants n=27 Participants
Age, Continuous	53.7 years STANDARD_DEVIATION 20.39 • n=93 Participants	53 years STANDARD_DEVIATION 16.93 • n=4 Participants	53.2 years STANDARD_DEVIATION 17.33 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	18 Participants n=4 Participants	22 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	12 Participants n=4 Participants	15 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=93 Participants	28 Participants n=4 Participants	33 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized White	5 Participants n=93 Participants	29 Participants n=4 Participants	34 Participants n=27 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment GERMANY	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment ITALY	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment POLAND	0 Participants n=93 Participants	7 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment SPAIN	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
Region of Enrollment UNITED STATES	2 Participants n=93 Participants	13 Participants n=4 Participants	15 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 257 days post-baseline (Baseline is Day 1)

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with TEAEs were reported. 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. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug in this study.

Outcome measures

Measure	Placebo-Nipocalimab n=7 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=37 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	4 Participants	18 Participants	22 Participants

PRIMARY outcome

Timeframe: Up to 257 days post-baseline

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both.

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. 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.

Outcome measures

Measure	Placebo-Nipocalimab n=7 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=37 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Serious Adverse Events (SAEs)	1 Participants	4 Participants	5 Participants

PRIMARY outcome

Timeframe: Up to 257 days post-baseline

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with treatment-emergent AESIs were reported. Severe infections and hypoalbuminemia (Grade 3 or higher according to the Common Terminology Criteria for Adverse Events [CTCAE] v5.0) were considered as AESIs.

Outcome measures

Measure	Placebo-Nipocalimab n=7 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=37 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)	1 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 257 days post-baseline

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with treatment-emergent abnormal vital signs including pulse rate (less than or equal to [<=] 50 beats per minutes [bpm] with greater than or equal to [>=] 15 bpm decrease from baseline, >= 120 bpm with >=15 bpm increase from baseline), systolic blood pressure (SBP) (<= 90 millimeters of mercury [mmHg] with >= 20 mmHg decrease from baseline, >= 160 mmHg with >= 20 mmHg increase from baseline) and diastolic blood pressure (DBP) (<= 50 mmHg with >=15 mmHg decrease from baseline, >=100 mmHg with >=15 mmHg decrease from baseline) were reported.

Outcome measures

Measure	Placebo-Nipocalimab n=7 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=37 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Treatment-emergent Abnormal Vital Signs Pulse rate: <=50 bpm with >=15 bpm decrease from baseline	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormal Vital Signs Pulse rate: >= 120 bpm with >=15 bpm increase from baseline	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormal Vital Signs SBP: <= 90 mmHg with >= 20 mmHg decrease from baseline	0 Participants	1 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormal Vital Signs SBP: >= 160 mmHg with >= 20 mmHg increase from baseline	0 Participants	1 Participants	1 Participants
Number of Participants With Treatment-emergent Abnormal Vital Signs DBP: <= 50 mmHg with >=15 mmHg decrease from baseline	0 Participants	2 Participants	2 Participants
Number of Participants With Treatment-emergent Abnormal Vital Signs DBP: >=100 mmHg with >=15 mmHg decrease from baseline	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with abnormalities in physical examinations (abdomen, head, ears, eyes, nose, throat, and sinuses, lungs, neurological, skin, blood and lymphatic system, cardiovascular, chest, gastrointestinal, general appearance and musculoskeletal) were reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=17 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=21 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Abnormalities in Physical Examinations Abdomen	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormalities in Physical Examinations Head, Ears, Eyes, Nose, Throat and Sinuses	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Physical Examinations Lungs	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormalities in Physical Examinations Neurological	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormalities in Physical Examinations Skin	1 Participants	4 Participants	5 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in chemistry laboratory parameters: albumin and protein were reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=17 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=21 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein Albumin	-1.5 grams per liter (g/L) Standard Deviation 2.89	-1.2 grams per liter (g/L) Standard Deviation 3.21	-1.3 grams per liter (g/L) Standard Deviation 3.08
Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein Protein	-3.5 grams per liter (g/L) Standard Deviation 2.08	-3.8 grams per liter (g/L) Standard Deviation 4.99	-3.7 grams per liter (g/L) Standard Deviation 4.54

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in chemistry laboratory parameters: bicarbonate, calcium, chloride, cholesterol, glucose, phosphate, potassium, sodium, triglycerides, urate and urea nitrogen were reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=17 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=21 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Glucose	0.280 millimoles per liter (mmol/L) Standard Deviation 0.5054	-0.258 millimoles per liter (mmol/L) Standard Deviation 1.1401	-0.155 millimoles per liter (mmol/L) Standard Deviation 1.0607
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Bicarbonate	-2.0 millimoles per liter (mmol/L) Standard Deviation 2.45	1.6 millimoles per liter (mmol/L) Standard Deviation 2.91	1.0 millimoles per liter (mmol/L) Standard Deviation 3.14
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Calcium	0.010 millimoles per liter (mmol/L) Standard Deviation 0.0627	-0.018 millimoles per liter (mmol/L) Standard Deviation 0.1005	-0.013 millimoles per liter (mmol/L) Standard Deviation 0.0938
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Chloride	0.5 millimoles per liter (mmol/L) Standard Deviation 1.91	0.6 millimoles per liter (mmol/L) Standard Deviation 2.85	0.6 millimoles per liter (mmol/L) Standard Deviation 2.66
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Cholesterol	0.480 millimoles per liter (mmol/L) Standard Deviation 1.0100	0.261 millimoles per liter (mmol/L) Standard Deviation 0.5732	0.303 millimoles per liter (mmol/L) Standard Deviation 0.6509
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Phosphate	-0.018 millimoles per liter (mmol/L) Standard Deviation 0.0971	-0.002 millimoles per liter (mmol/L) Standard Deviation 0.1903	-0.005 millimoles per liter (mmol/L) Standard Deviation 0.1744
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Potassium	0.05 millimoles per liter (mmol/L) Standard Deviation 0.173	0.05 millimoles per liter (mmol/L) Standard Deviation 0.583	0.05 millimoles per liter (mmol/L) Standard Deviation 0.526
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Sodium	0.8 millimoles per liter (mmol/L) Standard Deviation 0.96	1.4 millimoles per liter (mmol/L) Standard Deviation 2.18	1.2 millimoles per liter (mmol/L) Standard Deviation 2.00
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Triglycerides	0.223 millimoles per liter (mmol/L) Standard Deviation 0.5799	0.081 millimoles per liter (mmol/L) Standard Deviation 0.3223	0.108 millimoles per liter (mmol/L) Standard Deviation 0.3699
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Urate	-0.0090 millimoles per liter (mmol/L) Standard Deviation 0.04285	0.0174 millimoles per liter (mmol/L) Standard Deviation 0.04790	0.124 millimoles per liter (mmol/L) Standard Deviation 0.04716
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen Urea Nitrogen	-0.270 millimoles per liter (mmol/L) Standard Deviation 1.7830	-0.105 millimoles per liter (mmol/L) Standard Deviation 1.7292	-0.136 millimoles per liter (mmol/L) Standard Deviation 1.6951

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in chemistry laboratory parameters alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=17 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=21 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase ALT	17.0 units per liter (U/L) Standard Deviation 28.76	2.6 units per liter (U/L) Standard Deviation 5.33	5.3 units per liter (U/L) Standard Deviation 13.43
Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase Alkaline Phosphatase	6.3 units per liter (U/L) Standard Deviation 2.06	5.2 units per liter (U/L) Standard Deviation 11.46	5.4 units per liter (U/L) Standard Deviation 10.23
Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase AST	23.5 units per liter (U/L) Standard Deviation 47.67	0.9 units per liter (U/L) Standard Deviation 3.42	5.2 units per liter (U/L) Standard Deviation 20.80
Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase Creatine Kinase	-17.8 units per liter (U/L) Standard Deviation 33.13	13.6 units per liter (U/L) Standard Deviation 38.34	7.7 units per liter (U/L) Standard Deviation 38.73
Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase Gamma Glutamyl Transferase	4.3 units per liter (U/L) Standard Deviation 11.95	1.5 units per liter (U/L) Standard Deviation 13.21	2.0 units per liter (U/L) Standard Deviation 12.74
Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase Lactate Dehydrogenase	30.0 units per liter (U/L) Standard Deviation 15.68	30.9 units per liter (U/L) Standard Deviation 58.10	30.7 units per liter (U/L) Standard Deviation 52.00

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in chemistry laboratory parameters: bilirubin, creatinine and direct bilirubin were reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=17 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=21 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin Bilirubin	0.13 micromoles per liter (micromol/L) Standard Deviation 2.616	-0.59 micromoles per liter (micromol/L) Standard Deviation 2.403	-0.46 micromoles per liter (micromol/L) Standard Deviation 2.393
Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin Creatinine	-9.0 micromoles per liter (micromol/L) Standard Deviation 7.35	-2.6 micromoles per liter (micromol/L) Standard Deviation 13.20	-3.9 micromoles per liter (micromol/L) Standard Deviation 12.41
Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin Direct Bilirubin	-1.20 micromoles per liter (micromol/L) Standard Deviation NA Here, NA indicates that standard deviation cannot be calculated for 1 participant.	-0.70 micromoles per liter (micromol/L) Standard Deviation 0.283	-0.87 micromoles per liter (micromol/L) Standard Deviation 0.359

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in erythrocytes (red blood cells) (hematology laboratory parameter) was reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=16 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=20 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell)	0.188 10^12 cells count per Liter Standard Deviation 0.0822	0.121 10^12 cells count per Liter Standard Deviation 0.2702	0.135 10^12 cells count per Liter Standard Deviation 0.2438

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in hematology laboratory parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes were reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=16 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=20 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Basophils	-0.003 10^9 cells count per Liter Standard Deviation 0.0150	0.010 10^9 cells count per Liter Standard Deviation 0.0200	0.006 10^9 cells count per Liter Standard Deviation 0.0188
Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Eosinophils	0.015 10^9 cells count per Liter Standard Deviation 0.0465	0.013 10^9 cells count per Liter Standard Deviation 0.0776	0.014 10^9 cells count per Liter Standard Deviation 0.0702
Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Lymphocytes	-0.045 10^9 cells count per Liter Standard Deviation 0.4498	0.063 10^9 cells count per Liter Standard Deviation 0.4715	0.041 10^9 cells count per Liter Standard Deviation 0.4576
Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Monocytes	-0.105 10^9 cells count per Liter Standard Deviation 0.1964	0.059 10^9 cells count per Liter Standard Deviation 0.2008	0.027 10^9 cells count per Liter Standard Deviation 0.2061
Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Neutrophils	-0.433 10^9 cells count per Liter Standard Deviation 0.5744	0.411 10^9 cells count per Liter Standard Deviation 1.8622	0.243 10^9 cells count per Liter Standard Deviation 1.7058
Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Platelets	27.8 10^9 cells count per Liter Standard Deviation 11.81	12.3 10^9 cells count per Liter Standard Deviation 53.20	15.4 10^9 cells count per Liter Standard Deviation 47.93
Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Leukocytes	-0.568 10^9 cells count per Liter Standard Deviation 0.9214	0.567 10^9 cells count per Liter Standard Deviation 1.9956	0.340 10^9 cells count per Liter Standard Deviation 1.8694

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in erythrocytes mean corpuscular hemoglobin (HGB) concentration (hematology laboratory parameter) were reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=16 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=20 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration	-6.5 grams per Liter (g/L) Standard Deviation 25.70	-2.1 grams per Liter (g/L) Standard Deviation 7.61	-3.0 grams per Liter (g/L) Standard Deviation 12.38

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in erythrocytes mean corpuscular HGB (hematology laboratory parameter) was reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=16 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=20 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB)	0.03 picograms (pg) Standard Deviation 0.873	-0.61 picograms (pg) Standard Deviation 0.813	-0.48 picograms (pg) Standard Deviation 0.842

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in erythrocytes mean corpuscular volume (hematology laboratory parameter) was reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=16 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=20 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Hematology Laboratory Parameter: Erythrocytes Mean Corpuscular Volume	2.45 femtoliters (fL) Standard Deviation 6.174	-1.41 femtoliters (fL) Standard Deviation 3.406	-0.64 femtoliters (fL) Standard Deviation 4.206

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in hematocrit (hematology laboratory parameter) was reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=16 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=20 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Hematology Laboratory Parameter: Hematocrit	0.0278 liter of cells per liter of blood (L/L) Standard Deviation 0.03542	0.0048 liter of cells per liter of blood (L/L) Standard Deviation 0.02401	0.0094 liter of cells per liter of blood (L/L) Standard Deviation 0.02725

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in hemoglobin (hematology laboratory parameter) was reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=16 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=20 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Hematology Laboratory Parameter: Hemoglobin	5.8 g/L Standard Deviation 4.65	0.6 g/L Standard Deviation 7.29	1.7 g/L Standard Deviation 7.06

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in pH (urinalysis laboratory parameter) was reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=17 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=21 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Urinalysis Laboratory Parameter: pH	-0.8 pH Standard Deviation 0.96	0.0 pH Standard Deviation 1.06	-0.1 pH Standard Deviation 1.06

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in specific gravity (urinalysis laboratory parameter) was reported.

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=17 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=21 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity	-0.0003 ratio Standard Deviation 0.00660	-0.0030 ratio Standard Deviation 0.00973	-0.0025 ratio Standard Deviation 0.00914

PRIMARY outcome

Timeframe: Up to 257 days post-baseline

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with treatment-emergent abnormal ECG values for variables including mean heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute [bpm], abnormally high refers greater than or equal to [>=] 120 bpm), PR interval (abnormally low refers to < 120 and abnormally high refers to >200 milliseconds [msec]), RR interval (abnormally low refers to <600 msec and abnormally high refers to >1200 msec) and QRS duration (abnormally > 120) were reported.

Outcome measures

Measure	Placebo-Nipocalimab n=7 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=29 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=36 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values ECG Mean Heart Rate (<= 50)	0 Participants	5 Participants	5 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values ECG Mean Heart Rate (>=120)	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values PR Interval (<120)	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values PR Interval (> 200)	0 Participants	5 Participants	5 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values RR Interval (<600)	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values RR Interval (>=1200)	0 Participants	4 Participants	4 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values QRS Duration (>120)	1 Participants	3 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to 257 days post-baseline

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with C-SSRS scores were reported. C-SSRS is a clinician-administered questionnaire designed to solicit occurrence, severity, and frequency of suicide-related ideation and behaviors. Total score ranges from 1 to 10, score of 0 was assigned (0="no event that can be assessed based on C-SSRS"). Higher total scores indicate greater severity. Maximum score assigned for each participant was summarized into one of 3 categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5): higher score indicates more suicidal ideation, suicidal behavior (6 to 10): higher score indicates more suicidal behavior. Suicidal ideation includes participants who did not have suicidal ideation or behavior at baseline and had suicidal ideation without behavior at some time point post-baseline. Suicidal behavior includes participants who did not have suicidal ideation or behavior at baseline and had suicidal behavior at some time point post-baseline (baseline=Day 1).

Outcome measures

Measure	Placebo-Nipocalimab n=6 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=36 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Scores No Suicidal Ideation/Behavior	5 Participants	30 Participants	35 Participants
Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Scores Suicidal Ideation	1 Participants	0 Participants	1 Participants
Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Scores Suicidal Behavior	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 257 days post-baseline

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with at least one value above upper limit of normal (>ULN) or below the lower limit of normal (< LLN) value of coagulation parameters (activated partial thromboplastin time [APTT] and prothrombin time [PT]) were reported. The lab reference range for APTT is 25.1 to 36.5 seconds. The lab reference range for PT is 9.4 to 12.5 seconds.

Outcome measures

Measure	Placebo-Nipocalimab n=7 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=28 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=35 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Below/Above Normal Values of Coagulation Laboratory Parameter APTT (>ULN)	2 Participants	15 Participants	17 Participants
Number of Participants With Below/Above Normal Values of Coagulation Laboratory Parameter APTT (<LLN)	0 Participants	3 Participants	3 Participants
Number of Participants With Below/Above Normal Values of Coagulation Laboratory Parameter PT (>ULN)	1 Participants	8 Participants	9 Participants
Number of Participants With Below/Above Normal Values of Coagulation Laboratory Parameter PT (<ULN)	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Weeks 4, 8, 12, 24, End of treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

Population: The full analysis set (FAS) included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

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.

Outcome measures

Measure	Placebo-Nipocalimab n=5 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=26 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=31 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time Week 4	0.6 score on a scale Standard Deviation 1.34	-0.6 score on a scale Standard Deviation 2.42	-0.4 score on a scale Standard Deviation 2.30
Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time Week 8	-0.8 score on a scale Standard Deviation 3.70	-0.9 score on a scale Standard Deviation 2.63	-0.9 score on a scale Standard Deviation 2.80
Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time Week 12	-0.3 score on a scale Standard Deviation 4.35	-1.2 score on a scale Standard Deviation 2.49	-1.0 score on a scale Standard Deviation 2.82
Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time Week 24	-1.0 score on a scale Standard Deviation NA Here, NA indicates that standard deviation could not be calculated for 1 participant.	-1.2 score on a scale Standard Deviation 1.92	-1.2 score on a scale Standard Deviation 1.72
Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time EoT (up to 253 days post-baseline)	—	-2.4 score on a scale Standard Deviation 2.55	-2.4 score on a scale Standard Deviation 2.55
Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time Follow-up (up to 257 days post-baseline)	-0.6 score on a scale Standard Deviation 1.14	1.2 score on a scale Standard Deviation 3.08	0.9 score on a scale Standard Deviation 2.91

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, End of treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

Population: The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

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 over time were reported. 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.

Outcome measures

Measure	Placebo-Nipocalimab n=7 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=37 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding 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 Over Time Week 4 (2 Point Improvement)	—	2 Participants	2 Participants
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 Over Time Week 4 (3 Point Improvement)	—	1 Participants	1 Participants
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 Over Time Week 4 (4 Point Improvement)	—	0 Participants	0 Participants
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 Over Time Week 4 (5 Point Improvement)	—	1 Participants	1 Participants
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 Over Time Week 4 (6 Point Improvement)	—	2 Participants	2 Participants
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 Over Time Week 4 (7 Point Improvement)	—	0 Participants	0 Participants
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 Over Time Week 4 (>= 8 Point Improvement)	—	0 Participants	0 Participants
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 Over Time Week 8 (2 Point Improvement)	1 Participants	2 Participants	3 Participants
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 Over Time Week 8 (3 Point Improvement)	0 Participants	4 Participants	4 Participants
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 Over Time Week 8 (4 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Week 8 (5 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Week 8 (6 Point Improvement)	1 Participants	0 Participants	1 Participants
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 Over Time Week 8 (7 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Week 8 (>= 8 Point Improvement)	0 Participants	1 Participants	1 Participants
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 Over Time Week 12 (2 Point Improvement)	0 Participants	2 Participants	2 Participants
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 Over Time Week 12 (3 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Week 12 (4 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Week 12 (5 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Week 12 (6 Point Improvement)	1 Participants	3 Participants	4 Participants
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 Over Time Week 12 (7 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Week 12 (>= 8 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Week 24 (2 Point Improvement)	—	1 Participants	1 Participants
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 Over Time Week 24 (3 Point Improvement)	—	0 Participants	0 Participants
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 Over Time Week 24 (4 Point Improvement)	—	1 Participants	1 Participants
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 Over Time Week 24 (5 Point Improvement)	—	0 Participants	0 Participants
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 Over Time Week 24 (6 Point Improvement)	—	0 Participants	0 Participants
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 Over Time Week 24 (7 Point Improvement)	—	0 Participants	0 Participants
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 Over Time Week 24 (>= 8 Point Improvement)	—	0 Participants	0 Participants
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 Over Time EoT (up to 253 days post-baseline) (2 Point Improvement)	—	2 Participants	2 Participants
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 Over Time EoT (up to 253 days post-baseline) (3 Point Improvement)	—	2 Participants	2 Participants
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 Over Time EoT (up to 253 days post-baseline) (4 Point Improvement)	—	0 Participants	0 Participants
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 Over Time EoT (up to 253 days post-baseline) (5 Point Improvement)	—	1 Participants	1 Participants
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 Over Time EoT (up to 253 days post-baseline) (6 Point Improvement)	—	1 Participants	1 Participants
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 Over Time EoT (up to 253 days post-baseline) (7 Point Improvement)	—	2 Participants	2 Participants
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 Over Time EoT (up to 253 days post-baseline) (>= 8 Point Improvement)	—	0 Participants	0 Participants
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 Over Time Follow-up (up to 257 days post-baseline) (2 Point Improvement)	1 Participants	3 Participants	4 Participants
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 Over Time Follow-up (up to 257 days post-baseline) (3 Point Improvement)	0 Participants	1 Participants	1 Participants
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 Over Time Follow-up (up to 257 days post-baseline) (4 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Follow-up (up to 257 days post-baseline) (5 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Follow-up (up to 257 days post-baseline) (6 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Follow-up (up to 257 days post-baseline) (7 Point Improvement)	0 Participants	0 Participants	0 Participants
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 Over Time Follow-up (up to 257 days post-baseline) (>= 8 Point Improvement)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

Population: The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

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.

Outcome measures

Measure	Placebo-Nipocalimab n=2 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=9 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=11 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time Week 8	-3.0 score on a scale Standard Deviation 5.66	1.0 score on a scale Standard Deviation 1.53	0.1 score on a scale Standard Deviation 2.98
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time Week 12	-0.5 score on a scale Standard Deviation 3.54	-1.2 score on a scale Standard Deviation 2.23	-1.0 score on a scale Standard Deviation 2.33
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time Week 4	1.5 score on a scale Standard Deviation 6.36	-1.3 score on a scale Standard Deviation 2.60	-0.8 score on a scale Standard Deviation 3.28
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time Week 24	—	-2.7 score on a scale Standard Deviation 1.53	-2.7 score on a scale Standard Deviation 1.53
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time EoT (up to 253 days post-baseline)	—	-2.4 score on a scale Standard Deviation 4.12	-2.4 score on a scale Standard Deviation 4.12
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time Follow-up (up to 257 days post-baseline)	-3.0 score on a scale Standard Deviation NA Here, NA indicates that standard deviation could not be calculated for 1 participant.	-1.6 score on a scale Standard Deviation 2.07	-1.8 score on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: Baseline up to Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

Population: The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

The MG-QoL15r was used to assess the participant's limitations related to living with MG. It consists of 15 questions and 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.

Outcome measures

Measure	Placebo-Nipocalimab n=7 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=37 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time Week 4	1.4 score on a scale Standard Deviation 3.85	-2.2 score on a scale Standard Deviation 4.53	-1.6 score on a scale Standard Deviation 4.57
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time Week 8	-0.4 score on a scale Standard Deviation 3.97	-1.9 score on a scale Standard Deviation 4.34	-1.6 score on a scale Standard Deviation 4.23
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time Week 12	-1.0 score on a scale Standard Deviation 6.27	-3.4 score on a scale Standard Deviation 4.70	-2.9 score on a scale Standard Deviation 4.95
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time Week 24	-3.0 score on a scale Standard Deviation NA Here, NA indicates that standard deviation could not be calculated for 1 participant.	-1.4 score on a scale Standard Deviation 1.52	-1.7 score on a scale Standard Deviation 1.51
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time EoT (up to 253 days post-baseline)	—	-3.7 score on a scale Standard Deviation 5.28	-3.7 score on a scale Standard Deviation 5.28
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time Follow-up (up to 257 days post-baseline)	-1.3 score on a scale Standard Deviation 5.72	0.1 score on a scale Standard Deviation 3.11	-0.2 score on a scale Standard Deviation 3.69

SECONDARY outcome

Timeframe: Baseline up to Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

Population: The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

The CGI-S scale is the clinician/physician's global assessment of participants illness severity of MG and is rated by answering on 8-point scale. Considering total clinical experience, participant is assessed on severity of illness according to: 0=not performed; 1=normal, not at all ill; 2=borderline illness; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. Higher scores indicated more severity of illness. Values of 0 (not assessed) were excluded from analysis. CGI-S permits global evaluation of participant's condition at given time.

Outcome measures

Measure	Placebo-Nipocalimab n=5 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=26 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=31 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over Time Week 4	-0.2 score on a scale Standard Deviation 0.84	-0.3 score on a scale Standard Deviation 0.60	-0.3 score on a scale Standard Deviation 0.63
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over Time Week 8	-1.0 score on a scale Standard Deviation 0.71	-0.6 score on a scale Standard Deviation 0.90	-0.7 score on a scale Standard Deviation 0.86
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over Time Week 12	-0.5 score on a scale Standard Deviation 1.00	-0.5 score on a scale Standard Deviation 0.80	-0.5 score on a scale Standard Deviation 0.81
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over Time Week 24	0.0 score on a scale Standard Deviation NA Here, NA indicates that standard deviation could not be calculated for 1 participant.	-0.6 score on a scale Standard Deviation 0.89	-0.5 score on a scale Standard Deviation 0.84
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over Time EoT (up to 253 days post-baseline)	—	-0.7 score on a scale Standard Deviation 0.95	-0.7 score on a scale Standard Deviation 0.95
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over Time Follow-up (up to 257 days post-baseline)	-1.0 score on a scale Standard Deviation 1.22	-0.1 score on a scale Standard Deviation 0.73	-0.3 score on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)

Population: The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with improvement of illness based on CGI-I scale score over time were reported. The CGI-I scale is the clinician/physician's global assessment of the change in severity of the patient's generalized myasthenia gravis (gMG) since starting this study. The rating is given on a 7-point scale with lower scores indicating greater improvement (1= Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 =Minimally worse; 6 = Much worse; 7 = Very much worse. Values of 0 (not assessed) were excluded from analysis. Higher score indicates more severity.

Outcome measures

Measure	Placebo-Nipocalimab n=5 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=26 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=31 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 8 (Very much improved)	1 Participants	0 Participants	1 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 12 (Very much worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 12 (Much worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 24 (Much improved)	0 Participants	4 Participants	4 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Follow-up (up to 257 days post-baseline) (Very Much worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Follow-up (up to 257 days post-baseline) (Much worse)	1 Participants	2 Participants	3 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score EoT (up to 253 days post-baseline)(Much improved)	—	7 Participants	7 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score EoT (up to 253 days post-baseline)(Very much improved)	—	1 Participants	1 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 24 (Very Much worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 24 (Much worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 24 (Minimally worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 24 (No change)	1 Participants	0 Participants	1 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 24 (Minimally improved)	0 Participants	1 Participants	1 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 24 (Very Much improved)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score EoT (up to 253 days post-baseline)(Very Much worse)	—	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score EoT (up to 253 days post-baseline)(Much worse)	—	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score EoT (up to 253 days post-baseline) (Minimally worse)	—	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score EoT (up to 253 days post-baseline) (No change)	—	1 Participants	1 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score EoT (up to 253 days post-baseline)(Minimally improved)	—	7 Participants	7 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Follow-up (up to 257 days post-baseline) (Minimally worse)	0 Participants	3 Participants	3 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Follow-up (up to 257 days post-baseline) (No change)	0 Participants	5 Participants	5 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Follow-up (up to 257 days post-baseline) (Minimally improved)	0 Participants	8 Participants	8 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Follow-up (up to 257 days post-baseline) (Much improved)	3 Participants	2 Participants	5 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Follow-up (up to 257 days post-baseline) (Very much improved)	1 Participants	1 Participants	2 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 4 (Very much worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 4 (Much worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 4 (Minimally worse)	1 Participants	2 Participants	3 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 4 (No change)	1 Participants	7 Participants	8 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 4 (Minimally improved)	2 Participants	12 Participants	14 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 4 (Much improved)	0 Participants	5 Participants	5 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 4 (Very much improved)	1 Participants	0 Participants	1 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 8 (Very much worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 8 (Much worse)	0 Participants	0 Participants	0 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 8 (Minimally worse)	0 Participants	2 Participants	2 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 8 (No change)	0 Participants	3 Participants	3 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 8 (Minimally improved)	2 Participants	6 Participants	8 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 8 (Much improved)	2 Participants	8 Participants	10 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 12 (Minimally worse)	0 Participants	2 Participants	2 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 12 (No change)	2 Participants	1 Participants	3 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 12 (Minimally improved)	1 Participants	3 Participants	4 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 12 (Much improved)	1 Participants	10 Participants	11 Participants
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score Week 12 (Very much improved)	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Weeks 8, 24 and End of Treatment (EoT) (up to 253 days post-baseline)

Population: The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with change from baseline in MGFA classification score over time were reported. 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).

Outcome measures

Measure	Placebo-Nipocalimab n=4 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=9 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=13 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time Week 8 (Improved)	1 Participants	5 Participants	6 Participants
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time Week 8 (Same)	3 Participants	3 Participants	6 Participants
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time Week 8 (Worsened)	0 Participants	1 Participants	1 Participants
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time Week 24 (Improved)	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time Week 24 (Same)	1 Participants	1 Participants	2 Participants
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time Week 24 (Worsened)	0 Participants	0 Participants	0 Participants
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time EoT (up to 253 days post-baseline)(Improved)	—	4 Participants	4 Participants
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time EoT (up to 253 days post-baseline)(Same)	—	3 Participants	3 Participants
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time EoT (up to 253 days post-baseline)(Worsened)	—	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 257 days post-baseline

Population: The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Number of participants with ADA to nipocalimab were reported. The presence of ADA to nipocalimab in serum was determined by a sensitive and drug-tolerant electrochemiluminescence immunoassay (ECLIA) method.

Outcome measures

Measure	Placebo-Nipocalimab n=6 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=29 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=35 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Anti-drug Antibodies (ADA) to Nipocalimab	1 Participants	16 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to 257 days post-baseline

Population: FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were positive for antibodies to nipocalimab. Per planned analysis, both individual arms and an arm for all (total) participants is presented.

Number of participants with NAbs were reported. Neutralizing antibodies to nipocalimab were assessed using a non-cell based competitive ligand binding ECLIA assay.

Outcome measures

Measure	Placebo-Nipocalimab n=1 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=16 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=17 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Number of Participants With Neutralizing Antibodies (NAbs) to Nipocalimab	0 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline to Weeks 2, 4, 8, 12, 24, up to 253 days post-baseline, up to 257 days post-baseline

Population: The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' included the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both.

Change from baseline in serum immunoglobulin (Ig)G concentration over time was reported.

Outcome measures

Measure	Placebo-Nipocalimab n=5 Participants Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=27 Participants Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.	Nipocalimab (All Participants) n=32 Participants Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time Week 2	-6.888 g/L Standard Deviation 0.6104	-5.457 g/L Standard Deviation 1.2510	-5.681 g/L Standard Deviation 1.2804
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time Week 4	-3.234 g/L Standard Deviation 1.1858	-2.796 g/L Standard Deviation 0.9728	-2.866 g/L Standard Deviation 1.0014
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time Week 8	-2.996 g/L Standard Deviation 1.3773	-3.122 g/L Standard Deviation 1.3466	-3.095 g/L Standard Deviation 1.3235
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time Week 12	-3.243 g/L Standard Deviation 1.6378	-3.639 g/L Standard Deviation 2.2627	-3.563 g/L Standard Deviation 2.1269
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time Week 24	-3.870 g/L Standard Deviation NA Here, NA indicates that standard deviation could not be calculated for 1 participant.	-4.072 g/L Standard Deviation 1.2826	-4.038 g/L Standard Deviation 1.1502
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time 253 days post-baseline	—	-3.494 g/L Standard Deviation 1.9208	-3.494 g/L Standard Deviation 1.9208
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time 257 days post-baseline	-1.150 g/L Standard Deviation 0.5687	-0.020 g/L Standard Deviation 1.6162	-0.289 g/L Standard Deviation 1.5056

Adverse Events

Placebo-Nipocalimab

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Nipocalimab-Nipocalimab

Serious events: 4 serious events

Other events: 17 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo-Nipocalimab n=7 participants at risk Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 participants at risk Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Infections and infestations Coronavirus Infection	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Infections and infestations Covid-19 Pneumonia	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	0.00% 0/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gliosarcoma	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Nervous system disorders Myasthenia Gravis	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	6.7% 2/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.

Other adverse events

Measure	Placebo-Nipocalimab n=7 participants at risk Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W).	Nipocalimab-Nipocalimab n=30 participants at risk Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Ear and labyrinth disorders Vertigo Positional	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	0.00% 0/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Eye disorders Conjunctival Haemorrhage	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Eye disorders Conjunctival Hyperaemia	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	6.7% 2/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Gastrointestinal disorders Nausea	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	6.7% 2/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Gastrointestinal disorders Toothache	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	0.00% 0/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
General disorders Asthenia	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
General disorders Feeling Hot	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
General disorders Oedema Peripheral	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	10.0% 3/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
General disorders Peripheral Swelling	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
General disorders Pyrexia	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Infections and infestations Herpes Zoster	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Infections and infestations Nasopharyngitis	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Infections and infestations Oral Herpes	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Infections and infestations Otitis Media	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Infections and infestations Pharyngitis	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Infections and infestations Sinusitis	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	6.7% 2/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Injury, poisoning and procedural complications Contusion	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Injury, poisoning and procedural complications Foreign Body	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Injury, poisoning and procedural complications Wound	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Investigations Blood Immunoglobulin G Decreased	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	13.3% 4/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Investigations Blood Potassium Decreased	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Investigations Hepatic Enzyme Increased	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	0.00% 0/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Investigations Lymphocyte Count Decreased	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	6.7% 2/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Investigations Neutrophil Count Increased	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	6.7% 2/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Investigations Platelet Count Decreased	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Investigations White Blood Cell Count Increased	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Metabolism and nutrition disorders Vitamin B6 Deficiency	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Nervous system disorders Headache	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	6.7% 2/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Nervous system disorders Myasthenia Gravis	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	0.00% 0/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Nervous system disorders Neuropathy Peripheral	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Nervous system disorders Paraesthesia	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Psychiatric disorders Depressed Mood	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	0.00% 0/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Reproductive system and breast disorders Adenomyosis	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Reproductive system and breast disorders Menorrhagia	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Respiratory, thoracic and mediastinal disorders Aphonia	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Respiratory, thoracic and mediastinal disorders Increased Viscosity of Upper Respiratory Secretion	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	3.3% 1/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	14.3% 1/7 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.	0.00% 0/30 • Up to 257 days post-baseline (Day 1) The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab.

Additional Information

DIRECTOR CLINICAL RESEARCH

Momenta Pharmaceuticals, Inc.

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER