Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis (NCT NCT03772587)

NCT ID: NCT03772587

Last Updated: 2023-06-27

Results Overview

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE are defined as any AE occurring during or after the initiation of the first infusion of study drug.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 68 participants
• Primary outcome timeframe: Up to Day 113
• Results posted on: 2023-06-27

Participant Flow

Participant milestones

Measure	Placebo Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab (M281) 5 Milligrams/Kilogram (mg/kg) Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Study STARTED	14	14	13	13	14
Overall Study COMPLETED	13	14	12	12	14
Overall Study NOT COMPLETED	1	0	1	1	0

Reasons for withdrawal

Measure	Placebo Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab (M281) 5 Milligrams/Kilogram (mg/kg) Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Study COVID-19	0	0	1	1	0
Overall Study Withdrawal by Subject	1	0	0	0	0

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis

Baseline characteristics by cohort

Measure	Placebo n=14 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=13 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	8 Participants n=21 Participants	43 Participants n=8 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	25 Participants n=8 Participants
Age, Continuous	57.7 years STANDARD_DEVIATION 17.85 • n=5 Participants	54.8 years STANDARD_DEVIATION 17.64 • n=7 Participants	49 years STANDARD_DEVIATION 19.54 • n=5 Participants	53.1 years STANDARD_DEVIATION 15.4 • n=4 Participants	59.9 years STANDARD_DEVIATION 15.03 • n=21 Participants	55 years STANDARD_DEVIATION 17.07 • n=8 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	5 Participants n=21 Participants	37 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants	31 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	14 Participants n=21 Participants	63 Participants n=8 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	9 Participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	10 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	14 Participants n=21 Participants	58 Participants n=8 Participants
Region of Enrollment BELGIUM	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Region of Enrollment CANADA	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants
Region of Enrollment GERMANY	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants
Region of Enrollment ITALY	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants
Region of Enrollment POLAND	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=8 Participants
Region of Enrollment SPAIN	4 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	15 Participants n=8 Participants
Region of Enrollment UNITED KINGDOM	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Region of Enrollment UNITED STATES	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants	25 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to Day 113

Population: The safety population included all participants who received any amount of nipocalimab or placebo.

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE are defined as any AE occurring during or after the initiation of the first infusion of study drug.

Outcome measures

Measure	Placebo n=14 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=13 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	11 Participants	12 Participants	9 Participants	12 Participants	12 Participants

PRIMARY outcome

Timeframe: Up to Day 113

Population: The safety population included all participants who received any amount of nipocalimab or placebo.

An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.

Outcome measures

Measure	Placebo n=14 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=13 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 113

Population: The safety population included all participants who received any amount of nipocalimab or placebo.

An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. For this study, any common terminology criteria for adverse events (CTCAE) Grade 3 or higher event of severe infection or hypoalbuminemia was considered as AESI.

Outcome measures

Measure	Placebo n=14 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=13 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline to Day 57

Population: Intent-to-Treat (ITT) population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this outcome measure (OM).

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 n=11 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=12 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score	-1.8 score on a scale Standard Deviation 3.22	-2.5 score on a scale Standard Deviation 2.41	-3.9 score on a scale Standard Deviation 3.00	-1.5 score on a scale Standard Deviation 2.82	-3.9 score on a scale Standard Deviation 3.66

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: All participants over all arms with both an MG-ADL score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates MG-ADL change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available.

Estimate of additional change from baseline in MG-ADL total score for every 10 percent (%) additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57. The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.

Outcome measures

Measure	Placebo n=58 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57	-0.30 score on a scale per 10% IgG reduction Standard Error 0.136	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: All anti-AChR positive participants over all arms with both an MG-ADL score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates MG-ADL change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available.

Estimate of additional change from baseline in MG-ADL total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The MG-ADL was used to assess participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). Total score is sum of eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.

Outcome measures

Measure	Placebo n=55 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57	-0.33 score on a scale per 10% IgG reduction Standard Error 0.144	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: All participants over all arms with both an QMG score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates QMG change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available.

Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.

Outcome measures

Measure	Placebo n=58 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57	-0.38 score on a scale per 10% IgG reduction Standard Error 0.174	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: All anti-AChR positive participants over all arms with both an QMG score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates QMG change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available.

Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.

Outcome measures

Measure	Placebo n=55 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57	-0.45 score on a scale per 10% IgG reduction Standard Error 0.181	—	—	—	—

SECONDARY outcome

Timeframe: Day 57

Population: Population analyzed included ITT participants for whom data was available at Day 57.

The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.

Outcome measures

Measure	Placebo n=11 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=12 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57 3-point Improved	5 Participants	9 Participants	8 Participants	5 Participants	11 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 at Day 57 4-point Improved	1 Participants	5 Participants	5 Participants	3 Participants	7 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 at Day 57 5-point Improved	1 Participants	2 Participants	5 Participants	2 Participants	6 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 at Day 57 7-point Improved	1 Participants	1 Participants	3 Participants	0 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 at Day 57 >=8-point Improved	1 Participants	0 Participants	1 Participants	0 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 at Day 57 2-point Improved	7 Participants	9 Participants	10 Participants	7 Participants	12 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 at Day 57 6-point Improved	1 Participants	1 Participants	3 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.

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 n=11 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=13 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=10 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=11 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total QMG Score at Day 57	-3.7 score on a scale Standard Deviation 2.94	-3.5 score on a scale Standard Deviation 4.10	-4.1 score on a scale Standard Deviation 3.45	-1.5 score on a scale Standard Deviation 2.54	-5.9 score on a scale Standard Deviation 5.30

SECONDARY outcome

Timeframe: Day 57

Population: Population analyzed included ITT participants for whom data was available at Day 57.

The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.

Outcome measures

Measure	Placebo n=11 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=13 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=10 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=11 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 3-point Improved	8 Participants	6 Participants	6 Participants	4 Participants	10 Participants
Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 4-point Improved	5 Participants	5 Participants	6 Participants	3 Participants	10 Participants
Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 5-point Improved	5 Participants	5 Participants	5 Participants	1 Participants	8 Participants
Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 6-point Improved	2 Participants	5 Participants	4 Participants	1 Participants	5 Participants
Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 7-point Improved	2 Participants	5 Participants	1 Participants	0 Participants	3 Participants
Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57 >= 8-point Improved	2 Participants	3 Participants	1 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.

The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation.

Outcome measures

Measure	Placebo n=11 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=12 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57	-2.0 score on a scale Standard Deviation 4.58	-1.7 score on a scale Standard Deviation 4.16	-6.8 score on a scale Standard Deviation 5.73	-1.2 score on a scale Standard Deviation 1.91	-3.7 score on a scale Standard Deviation 5.37

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.

Change from baseline in total serum IgG was reported. Blood samples were collected for analysis of total serum IgG.

Outcome measures

Measure	Placebo n=12 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=13 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=10 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=11 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total Serum IgG at Day 57	-0.3 gram/liter (g/L) Standard Deviation 1.82	-1.5 gram/liter (g/L) Standard Deviation 1.01	-3.4 gram/liter (g/L) Standard Deviation 1.01	-1.7 gram/liter (g/L) Standard Deviation 1.23	-7.6 gram/liter (g/L) Standard Deviation 2.27

SECONDARY outcome

Timeframe: Baseline, Day 85 and Day 113

Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints.

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 n=12 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=12 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 Day 113	-2.6 score on a scale Standard Deviation 3.09	-1.0 score on a scale Standard Deviation 2.25	-2.8 score on a scale Standard Deviation 2.33	-2.4 score on a scale Standard Deviation 2.78	-2.6 score on a scale Standard Deviation 3.30
Change From Baseline in Total MG-ADL Score at Day 85 and Day 113 Day 85	-2.2 score on a scale Standard Deviation 2.64	-2.1 score on a scale Standard Deviation 2.40	-3.7 score on a scale Standard Deviation 2.69	-1.9 score on a scale Standard Deviation 2.29	-3.6 score on a scale Standard Deviation 2.79

SECONDARY outcome

Timeframe: Baseline, Day 85 and Day 113

Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints.

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 n=10 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=10 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=9 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total QMG Score at Day 85 and Day 113 Day 85	-4.0 score on a scale Standard Deviation 2.62	-3.6 score on a scale Standard Deviation 3.23	-4.8 score on a scale Standard Deviation 2.49	-2.0 score on a scale Standard Deviation 2.60	-5.1 score on a scale Standard Deviation 3.52
Change From Baseline in Total QMG Score at Day 85 and Day 113 Day 113	-4.7 score on a scale Standard Deviation 3.04	-2.1 score on a scale Standard Deviation 2.40	-4.2 score on a scale Standard Deviation 3.08	-3.2 score on a scale Standard Deviation 2.28	-3.3 score on a scale Standard Deviation 5.69

SECONDARY outcome

Timeframe: Baseline, Day 85 and Day 113

Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints.

The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation.

Outcome measures

Measure	Placebo n=12 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=12 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 Day 85	-2.5 score on a scale Standard Deviation 2.84	-2.9 score on a scale Standard Deviation 3.74	-6.5 score on a scale Standard Deviation 5.66	-0.7 score on a scale Standard Deviation 4.25	-3.5 score on a scale Standard Deviation 5.61
Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113 Day 113	-3.2 score on a scale Standard Deviation 3.90	-1.6 score on a scale Standard Deviation 4.20	-4.2 score on a scale Standard Deviation 4.32	-1.0 score on a scale Standard Deviation 2.92	-2.5 score on a scale Standard Deviation 6.09

SECONDARY outcome

Timeframe: Baseline and Day 57

Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.

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 n=12 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=12 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=11 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=12 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=12 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 Improved	6 Participants	3 Participants	7 Participants	4 Participants	7 Participants
Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 Same	6 Participants	9 Participants	3 Participants	8 Participants	4 Participants
Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 Worsened	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to Day 113

Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.

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 n=9 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=9 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=8 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=7 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=11 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Number of Participants With Shift From Baseline in MGFA Classification to Day 113 Improved	3 Participants	2 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Shift From Baseline in MGFA Classification to Day 113 Same	6 Participants	5 Participants	4 Participants	5 Participants	5 Participants
Number of Participants With Shift From Baseline in MGFA Classification to Day 113 Worsened	0 Participants	2 Participants	1 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, Day 85 and Day 113

Population: ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints.

Change from baseline in total serum IgG at Day 85 and Day 113 was analyzed. Blood samples were collected for analysis of total serum IgG.

Outcome measures

Measure	Placebo n=11 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=11 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=9 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=13 Participants Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Change From Baseline in Total Serum IgG at Day 85 and Day 113 Day 85	-0.5 g/L Standard Deviation 1.02	-1.4 g/L Standard Deviation 1.93	-3.8 g/L Standard Deviation 1.28	-1.2 g/L Standard Deviation 1.02	-5.7 g/L Standard Deviation 2.30
Change From Baseline in Total Serum IgG at Day 85 and Day 113 Day 113	-0.6 g/L Standard Deviation 1.19	-0.7 g/L Standard Deviation 1.48	-1.2 g/L Standard Deviation 0.78	-0.7 g/L Standard Deviation 1.09	-2.2 g/L Standard Deviation 1.73

SECONDARY outcome

Timeframe: Baseline (Pre Infusion and Post Infusion), Day 15 (Pre Infusion), Day 29 (Pre Infusion), Day 43 (Pre Infusion), Day 57 (Pre Infusion and Post Infusion) and Day 85

Population: The safety population included all participants who received any amount of nipocalimab or placebo. Here 'n' (number analyzed) included the number of participants evaluated for specific timepoints.

Serum concentrations of nipocalimab were reported. Concentrations below the lowest quantifiable concentration (< LLOQ) that is <0.15 microgram/milliliter (mcg/mL) was treated as zero in calculating the summary statistics.

Outcome measures

Measure	Placebo n=14 Participants Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=13 Participants Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=13 Participants Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=14 Participants Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Serum Concentrations of Nipocalimab Baseline (Pre Infusion)	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.005	0.00 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	—
Serum Concentrations of Nipocalimab Baseline (Post Infusion)	117.75 micrograms/milliliter (mcg/mL) Standard Deviation 84.835	746.80 micrograms/milliliter (mcg/mL) Standard Deviation 47.214	1847.50 micrograms/milliliter (mcg/mL) Standard Deviation 153.270	1325.00 micrograms/milliliter (mcg/mL) Standard Deviation 616.443	—
Serum Concentrations of Nipocalimab Day 15 (Pre Infusion)	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.006	0.01 micrograms/milliliter (mcg/mL) Standard Deviation 0.010	27.61 micrograms/milliliter (mcg/mL) Standard Deviation 42.167	29.30 micrograms/milliliter (mcg/mL) Standard Deviation 36.631	—
Serum Concentrations of Nipocalimab Day 29 (Pre Infusion)	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.004	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	72.69 micrograms/milliliter (mcg/mL) Standard Deviation 152.058	—
Serum Concentrations of Nipocalimab Day 43 (Pre Infusion)	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.004	0.01 micrograms/milliliter (mcg/mL) Standard Deviation 0.013	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	66.72 micrograms/milliliter (mcg/mL) Standard Deviation 85.919	—
Serum Concentrations of Nipocalimab Day 57 (Pre Infusion)	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.006	95.40 micrograms/milliliter (mcg/mL) Standard Deviation 301.681	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	44.80 micrograms/milliliter (mcg/mL) Standard Deviation 68.560	—
Serum Concentrations of Nipocalimab Day 57 (Post Infusion)	49.15 micrograms/milliliter (mcg/mL) Standard Deviation 41.507	746.50 micrograms/milliliter (mcg/mL) Standard Deviation 96.874	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	1827.50 micrograms/milliliter (mcg/mL) Standard Deviation 741.052	—
Serum Concentrations of Nipocalimab Day 85	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.007	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.0	0.0 micrograms/milliliter (mcg/mL) Standard Deviation 0.004	—

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Nipocalimab 5 Milligrams/Kilogram (mg/kg)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Nipocalimab 30 mg/kg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Nipocalimab 60 mg/kg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Nipocalimab 60 mg/kg (Q2W)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=14 participants at risk Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 participants at risk Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=13 participants at risk Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 participants at risk Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 participants at risk Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Ischaemic Stroke	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Myasthenia Gravis	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.

Other adverse events

Measure	Placebo n=14 participants at risk Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.	Nipocalimab 5 Milligrams/Kilogram (mg/kg) n=14 participants at risk Participants received IV infusion of 5 mg/kg nipocalimab once every 4 weeks (Q4W) starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 30 mg/kg n=13 participants at risk Participants received IV infusion of 30 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.	Nipocalimab 60 mg/kg n=13 participants at risk Participants received IV infusion of 60 mg/kg nipocalimab single dose on Day 1. To maintain blinding, participants received matching placebo on Days 15, 29, 43 and 57.	Nipocalimab 60 mg/kg (Q2W) n=14 participants at risk Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Gastrointestinal disorders Vomiting	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Chest Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Feeling Cold	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Feeling Hot	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Hernia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Infusion Site Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Malaise	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Oedema Peripheral	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	14.3% 2/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Peripheral Swelling	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Vessel Puncture Site Pruritus	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
General disorders Vessel Puncture Site Swelling	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Asymptomatic Bacteriuria	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Blood and lymphatic system disorders Iron Deficiency Anaemia	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Cardiac disorders Palpitations	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Ear and labyrinth disorders Tinnitus	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Endocrine disorders Hypothyroidism	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Eye disorders Blepharitis	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Eye disorders Eye Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Eye disorders Eyelid Ptosis	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Eye disorders Vision Blurred	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Gastrointestinal disorders Constipation	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Gastrointestinal disorders Diarrhoea	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	15.4% 2/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	14.3% 2/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Gastrointestinal disorders Dysphagia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Gastrointestinal disorders Nausea	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Gastrointestinal disorders Salivary Hypersecretion	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Gastrointestinal disorders Toothache	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Bronchitis	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Cellulitis	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Conjunctivitis	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Herpes Zoster	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Hordeolum	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Influenza	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Nasopharyngitis	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	15.4% 2/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	14.3% 2/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Pharyngitis	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Pneumonia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Sinusitis	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Upper Respiratory Tract Infection	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Urinary Tract Infection	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	14.3% 2/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Injury, poisoning and procedural complications Contusion	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Injury, poisoning and procedural complications Fall	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Injury, poisoning and procedural complications Limb Injury	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Injury, poisoning and procedural complications Muscle Rupture	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Injury, poisoning and procedural complications Palate Injury	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Alanine Aminotransferase Increased	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Aspartate Aminotransferase Increased	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Bacterial Test	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Blood Pressure Increased	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Carbohydrate Antigen 19-9 Increased	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Helicobacter Test Positive	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Liver Function Test Increased	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Lymphocyte Count Decreased	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Neutrophil Count Increased	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Neutrophil Percentage Increased	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Urine Analysis Abnormal	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Investigations Weight Decreased	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Metabolism and nutrition disorders Glucose Tolerance Impaired	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	15.4% 2/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Muscle Spasms	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Muscle Twitching	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	15.4% 2/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Musculoskeletal and connective tissue disorders Spinal Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Dizziness	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	15.4% 2/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Dysgeusia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Headache	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	14.3% 2/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	15.4% 2/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Hypoaesthesia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	15.4% 2/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Mononeuropathy	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Myasthenia Gravis	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Presyncope	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Nervous system disorders Tension Headache	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Respiratory, thoracic and mediastinal disorders Catarrh	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Skin and subcutaneous tissue disorders Rash	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	21.4% 3/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Skin and subcutaneous tissue disorders Rash Erythematous	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Skin and subcutaneous tissue disorders Skin Swelling	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Skin and subcutaneous tissue disorders Swelling Face	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Vascular disorders Brachiocephalic Vein Thrombosis	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Vascular disorders Hypertension	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	14.3% 2/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	7.7% 1/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.
Vascular disorders Hypotension	7.1% 1/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/13 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.	0.00% 0/14 • Up to Day 113 The safety population included all participants who received any amount of nipocalimab or placebo.

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