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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772587
Recruitment Status : Completed
First Posted : December 11, 2018
Results First Posted : October 27, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Generalized Myasthenia Gravis
Interventions Drug: M281
Other: Placebo
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Nipocalimab (M281) 5 Milligrams/Kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57. 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. 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. 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. Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Period Title: Overall Study
Started 14 14 13 13 14
Completed 13 14 12 12 14
Not Completed 1 0 1 1 0
Reason Not Completed
COVID-19             0             0             1             1             0
Withdrawal by Subject             1             0             0             0             0
Arm/Group Title Placebo Nipocalimab 5 Milligrams/Kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W) Total
Hide Arm/Group Description Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57. 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. 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. 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. Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57. Total of all reporting groups
Overall Number of Baseline Participants 14 14 13 13 14 68
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 13 participants 13 participants 14 participants 68 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  57.1%
9
  64.3%
9
  69.2%
9
  69.2%
8
  57.1%
43
  63.2%
>=65 years
6
  42.9%
5
  35.7%
4
  30.8%
4
  30.8%
6
  42.9%
25
  36.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 13 participants 13 participants 14 participants 68 participants
57.7  (17.85) 54.8  (17.64) 49  (19.54) 53.1  (15.4) 59.9  (15.03) 55  (17.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 13 participants 13 participants 14 participants 68 participants
Female
8
  57.1%
6
  42.9%
9
  69.2%
9
  69.2%
5
  35.7%
37
  54.4%
Male
6
  42.9%
8
  57.1%
4
  30.8%
4
  30.8%
9
  64.3%
31
  45.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 14 participants 14 participants 13 participants 13 participants 14 participants 68 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   7.7%
0
   0.0%
0
   0.0%
1
   1.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
12
  85.7%
12
  85.7%
12
  92.3%
13
 100.0%
14
 100.0%
63
  92.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
2
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 14 participants 14 participants 13 participants 13 participants 14 participants 68 participants
Hispanic or Latino
4
  28.6%
1
   7.1%
3
  23.1%
1
   7.7%
0
   0.0%
9
  13.2%
Not Hispanic or Latino
10
  71.4%
13
  92.9%
10
  76.9%
11
  84.6%
14
 100.0%
58
  85.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.7%
0
   0.0%
1
   1.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 14 participants 14 participants 13 participants 13 participants 14 participants 68 participants
BELGIUM
1
   7.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.5%
CANADA
2
  14.3%
2
  14.3%
0
   0.0%
0
   0.0%
1
   7.1%
5
   7.4%
GERMANY
1
   7.1%
3
  21.4%
1
   7.7%
0
   0.0%
0
   0.0%
5
   7.4%
ITALY
2
  14.3%
2
  14.3%
1
   7.7%
0
   0.0%
0
   0.0%
5
   7.4%
POLAND
1
   7.1%
2
  14.3%
1
   7.7%
3
  23.1%
1
   7.1%
8
  11.8%
SPAIN
4
  28.6%
0
   0.0%
6
  46.2%
2
  15.4%
3
  21.4%
15
  22.1%
UNITED KINGDOM
0
   0.0%
0
   0.0%
0
   0.0%
3
  23.1%
1
   7.1%
4
   5.9%
UNITED STATES
3
  21.4%
5
  35.7%
4
  30.8%
5
  38.5%
8
  57.1%
25
  36.8%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
Hide Description An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE are defined as any AE occurring during or after the initiation of the first infusion of study drug.
Time Frame Up to Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of nipocalimab or placebo.
Arm/Group Title Placebo Nipocalimab 5 Milligrams/Kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57.
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.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 14 14 13 13 14
Measure Type: Count of Participants
Unit of Measure: Participants
11
  78.6%
12
  85.7%
9
  69.2%
12
  92.3%
12
  85.7%
2.Primary Outcome
Title Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Time Frame Up to Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of nipocalimab or placebo.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 14 14 13 13 14
Measure Type: Count of Participants
Unit of Measure: Participants
2
  14.3%
0
   0.0%
1
   7.7%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
Hide Description An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. For this study, any common terminology criteria for adverse events (CTCAE) Grade 3 or higher event of severe infection or hypoalbuminemia was considered as AESI.
Time Frame Up to Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of nipocalimab or placebo.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 14 14 13 13 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score
Hide Description The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Time Frame Baseline to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this outcome measure (OM).
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 11 14 12 13 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.8  (3.22) -2.5  (2.41) -3.9  (3.00) -1.5  (2.82) -3.9  (3.66)
5.Secondary Outcome
Title Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57
Hide Description Estimate of additional change from baseline in MG-ADL total score for every 10 percent (%) additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57. The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
All participants over all arms with both an MG-ADL score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates MG-ADL change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available.
Arm/Group Title Placebo/Nipocalimab (All Participants)
Hide Arm/Group Description:
All participants combined over all arms received IV infusion either of placebo or nipocalimab (5 mg/kg [once Q4W]/30 mg/kg[once Q4W]/60 mg/kg[once Q4W]/60 mg/kg [once Q2W]) starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 58
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale per 10% IgG reduction
-0.30  (0.136)
6.Secondary Outcome
Title 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
Hide Description Estimate of additional change from baseline in MG-ADL total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The MG-ADL was used to assess participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). Total score is sum of eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
All anti-AChR positive participants over all arms with both an MG-ADL score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates MG-ADL change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available.
Arm/Group Title Placebo/Nipocalimab (All Anti-AChR Positive Participants)
Hide Arm/Group Description:
All anti-AChR positive participants combined over all arms received IV infusion of either placebo or nipocalimab (5 mg/kg [once Q4W]/30 mg/kg[once Q4W]/60 mg/kg[once Q4W]/60 mg/kg [once Q2W]) starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 55
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale per 10% IgG reduction
-0.33  (0.144)
7.Secondary Outcome
Title Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57
Hide Description Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
All participants over all arms with both an QMG score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates QMG change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available.
Arm/Group Title Placebo/Nipocalimab (All Participants)
Hide Arm/Group Description:
All participants combined over all arms received IV infusion of either placebo or nipocalimab (5 mg/kg [once Q4W]/30 mg/kg[once Q4W]/60 mg/kg[once Q4W]/60 mg/kg [once Q2W]) starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 58
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale per 10% IgG reduction
-0.38  (0.174)
8.Secondary Outcome
Title 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
Hide Description Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
All anti-AChR positive participants over all arms with both an QMG score and an IgG result at both baseline and Day 57 are included in the analysis. Participants are combined over all groups because the analysis correlates QMG change with IgG change and arm was not included as a factor in the pre-specified analysis. Therefore, results by arm are not available.
Arm/Group Title Placebo/Nipocalimab (All Anti-AChR Positive Participants)
Hide Arm/Group Description:
All anti-AChR positive participants combined over all arms received IV infusion of either placebo or nipocalimab (5 mg/kg [once Q4W]/30 mg/kg[once Q4W]/60 mg/kg[once Q4W]/60 mg/kg [once Q2W]) starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 55
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale per 10% IgG reduction
-0.45  (0.181)
9.Secondary Outcome
Title 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
Hide Description The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included ITT participants for whom data was available at Day 57.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 11 14 12 13 14
Measure Type: Count of Participants
Unit of Measure: Participants
2-point Improved
7
  63.6%
9
  64.3%
10
  83.3%
7
  53.8%
12
  85.7%
3-point Improved
5
  45.5%
9
  64.3%
8
  66.7%
5
  38.5%
11
  78.6%
4-point Improved
1
   9.1%
5
  35.7%
5
  41.7%
3
  23.1%
7
  50.0%
5-point Improved
1
   9.1%
2
  14.3%
5
  41.7%
2
  15.4%
6
  42.9%
6-point Improved
1
   9.1%
1
   7.1%
3
  25.0%
1
   7.7%
3
  21.4%
7-point Improved
1
   9.1%
1
   7.1%
3
  25.0%
0
   0.0%
2
  14.3%
>=8-point Improved
1
   9.1%
0
   0.0%
1
   8.3%
0
   0.0%
2
  14.3%
10.Secondary Outcome
Title Change From Baseline in Total QMG Score at Day 57
Hide Description The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 11 13 10 11 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.7  (2.94) -3.5  (4.10) -4.1  (3.45) -1.5  (2.54) -5.9  (5.30)
11.Secondary Outcome
Title Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57
Hide Description The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed included ITT participants for whom data was available at Day 57.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 11 13 10 11 13
Measure Type: Count of Participants
Unit of Measure: Participants
3-point Improved
8
  72.7%
6
  46.2%
6
  60.0%
4
  36.4%
10
  76.9%
4-point Improved
5
  45.5%
5
  38.5%
6
  60.0%
3
  27.3%
10
  76.9%
5-point Improved
5
  45.5%
5
  38.5%
5
  50.0%
1
   9.1%
8
  61.5%
6-point Improved
2
  18.2%
5
  38.5%
4
  40.0%
1
   9.1%
5
  38.5%
7-point Improved
2
  18.2%
5
  38.5%
1
  10.0%
0
   0.0%
3
  23.1%
>= 8-point Improved
2
  18.2%
3
  23.1%
1
  10.0%
0
   0.0%
3
  23.1%
12.Secondary Outcome
Title Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57
Hide Description The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation.
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 11 14 12 13 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.0  (4.58) -1.7  (4.16) -6.8  (5.73) -1.2  (1.91) -3.7  (5.37)
13.Secondary Outcome
Title Change From Baseline in Total Serum IgG at Day 57
Hide Description Change from baseline in total serum IgG was reported. Blood samples were collected for analysis of total serum IgG.
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 12 13 10 11 13
Mean (Standard Deviation)
Unit of Measure: gram/liter (g/L)
-0.3  (1.82) -1.5  (1.01) -3.4  (1.01) -1.7  (1.23) -7.6  (2.27)
14.Secondary Outcome
Title Change From Baseline in Total MG-ADL Score at Day 85 and Day 113
Hide Description The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Time Frame Baseline, Day 85 and Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 12 14 12 13 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 85 Number Analyzed 11 participants 14 participants 11 participants 13 participants 14 participants
-2.2  (2.64) -2.1  (2.40) -3.7  (2.69) -1.9  (2.29) -3.6  (2.79)
Day 113 Number Analyzed 12 participants 14 participants 12 participants 12 participants 14 participants
-2.6  (3.09) -1.0  (2.25) -2.8  (2.33) -2.4  (2.78) -2.6  (3.30)
15.Secondary Outcome
Title Change From Baseline in Total QMG Score at Day 85 and Day 113
Hide Description The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Time Frame Baseline, Day 85 and Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints.
Arm/Group Title Placebo Nipocalimab 5 Milligram/Kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 10 14 10 9 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 85 Number Analyzed 10 participants 13 participants 9 participants 9 participants 13 participants
-4.0  (2.62) -3.6  (3.23) -4.8  (2.49) -2.0  (2.60) -5.1  (3.52)
Day 113 Number Analyzed 9 participants 14 participants 10 participants 9 participants 12 participants
-4.7  (3.04) -2.1  (2.40) -4.2  (3.08) -3.2  (2.28) -3.3  (5.69)
16.Secondary Outcome
Title Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113
Hide Description The MG-QoL15r was used to assess the participant's limitations related to living with MG. Each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation.
Time Frame Baseline, Day 85 and Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 12 14 12 13 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 85 Number Analyzed 11 participants 14 participants 11 participants 13 participants 13 participants
-2.5  (2.84) -2.9  (3.74) -6.5  (5.66) -0.7  (4.25) -3.5  (5.61)
Day 113 Number Analyzed 12 participants 14 participants 12 participants 12 participants 13 participants
-3.2  (3.90) -1.6  (4.20) -4.2  (4.32) -1.0  (2.92) -2.5  (6.09)
17.Secondary Outcome
Title Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57
Hide Description The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III).
Time Frame Baseline and Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 12 12 11 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Improved
6
  50.0%
3
  25.0%
7
  63.6%
4
  33.3%
7
  58.3%
Same
6
  50.0%
9
  75.0%
3
  27.3%
8
  66.7%
4
  33.3%
Worsened
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
1
   8.3%
18.Secondary Outcome
Title Number of Participants With Shift From Baseline in MGFA Classification to Day 113
Hide Description The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III).
Time Frame Baseline to Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 9 9 8 7 11
Measure Type: Count of Participants
Unit of Measure: Participants
Improved
3
  33.3%
2
  22.2%
3
  37.5%
2
  28.6%
3
  27.3%
Same
6
  66.7%
5
  55.6%
4
  50.0%
5
  71.4%
5
  45.5%
Worsened
0
   0.0%
2
  22.2%
1
  12.5%
0
   0.0%
3
  27.3%
19.Secondary Outcome
Title Change From Baseline in Total Serum IgG at Day 85 and Day 113
Hide Description Change from baseline in total serum IgG at Day 85 and Day 113 was analyzed. Blood samples were collected for analysis of total serum IgG.
Time Frame Baseline, Day 85 and Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM and 'n' (number analyzed) included the number of participants evaluated for specific timepoints.
Arm/Group Title Placebo Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of placebo matching to nipocalimab once Q2W starting Day 1 up to Day 57.
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 11 14 11 9 13
Mean (Standard Deviation)
Unit of Measure: g/L
Day 85 Number Analyzed 11 participants 13 participants 10 participants 9 participants 13 participants
-0.5  (1.02) -1.4  (1.93) -3.8  (1.28) -1.2  (1.02) -5.7  (2.30)
Day 113 Number Analyzed 10 participants 14 participants 11 participants 9 participants 12 participants
-0.6  (1.19) -0.7  (1.48) -1.2  (0.78) -0.7  (1.09) -2.2  (1.73)
20.Secondary Outcome
Title Serum Concentrations of Nipocalimab
Hide Description Serum concentrations of nipocalimab were reported. Concentrations below the lowest quantifiable concentration (< LLOQ) that is <0.15 microgram/milliliter (mcg/mL) was treated as zero in calculating the summary statistics.
Time Frame Baseline (Pre Infusion and Post Infusion), Day 15 (Pre Infusion), Day 29 (Pre Infusion), Day 43 (Pre Infusion), Day 57 (Pre Infusion and Post Infusion) and Day 85
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of nipocalimab or placebo. Here 'n' (number analyzed) included the number of participants evaluated for specific timepoints.
Arm/Group Title Nipocalimab 5 mg/kg Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description:
Participants received IV infusion of 5 mg/kg nipocalimab once Q4W starting Day 1 up to Day 57. To maintain blinding, participants received matching placebo on Days 15 and 43.
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.
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.
Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
Overall Number of Participants Analyzed 14 13 13 14
Mean (Standard Deviation)
Unit of Measure: micrograms/milliliter (mcg/mL)
Baseline (Pre Infusion) Number Analyzed 14 participants 12 participants 13 participants 14 participants
0.0  (0.0) 0.02  (0.066) 0.0  (0.0) 0.0  (0.0)
Baseline (Post Infusion) Number Analyzed 13 participants 12 participants 13 participants 14 participants
107.35  (39.826) 708.07  (95.185) 1739.93  (287.127) 1794.93  (1308.695)
Day 15 (Pre Infusion) Number Analyzed 13 participants 13 participants 13 participants 14 participants
0.0  (0.0) 0.0  (0.0) 22.56  (36.198) 25.38  (33.402)
Day 29 (Pre Infusion) Number Analyzed 14 participants 10 participants 11 participants 14 participants
0.0  (0.0) 0.02  (0.052) 0.0  (0.0) 58.34  (113.158)
Day 43 (Pre Infusion) Number Analyzed 14 participants 12 participants 11 participants 14 participants
0.0  (0.0) 0.0  (0.0) 0.0  (0.0) 61.28  (80.513)
Day 57 (Pre Infusion) Number Analyzed 13 participants 10 participants 11 participants 13 participants
0.0  (0.0) 0.02  (0.71) 0.0  (0.0) 35.95  (54.440)
Day 57 (Post Infusion) Number Analyzed 12 participants 9 participants 11 participants 13 participants
105.65  (43.331) 752.47  (154.608) 0.0  (0.0) 1568.92  (288.500)
Day 85 Number Analyzed 13 participants 10 participants 9 participants 13 participants
0.0  (0.0) 0.03  (0.08) 0.0  (0.0) 0.0  (0.0)
Time Frame Up to Day 113
Adverse Event Reporting Description The safety population included all participants who received any amount of nipocalimab or placebo.
 
Arm/Group Title Placebo Nipocalimab 5 Milligrams/Kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Hide Arm/Group Description Participants received intravenous (IV) infusion of placebo matching to nipocalimab once every 2 weeks (Q2W) starting Day 1 up to Day 57. 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. 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. 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. Participants received IV infusion of 60 mg/kg nipocalimab once Q2W starting Day 1 up to Day 57.
All-Cause Mortality
Placebo Nipocalimab 5 Milligrams/Kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/14 (0.00%) 
Hide Serious Adverse Events
Placebo Nipocalimab 5 Milligrams/Kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/14 (14.29%)   0/14 (0.00%)   1/13 (7.69%)   0/13 (0.00%)   0/14 (0.00%) 
Musculoskeletal and connective tissue disorders           
Musculoskeletal Pain * 1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Nervous system disorders           
Ischaemic Stroke * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Myasthenia Gravis * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Nipocalimab 5 Milligrams/Kilogram (mg/kg) Nipocalimab 30 mg/kg Nipocalimab 60 mg/kg Nipocalimab 60 mg/kg (Q2W)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/14 (71.43%)   12/14 (85.71%)   8/13 (61.54%)   12/13 (92.31%)   12/14 (85.71%) 
Blood and lymphatic system disorders           
Iron Deficiency Anaemia * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Thrombocytopenia * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Cardiac disorders           
Palpitations * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Ear and labyrinth disorders           
Tinnitus * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Endocrine disorders           
Hypothyroidism * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Eye disorders           
Blepharitis * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Eye Pain * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Eyelid Ptosis * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Vision Blurred * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders           
Abdominal Pain Upper * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/14 (7.14%) 
Constipation * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Diarrhoea * 1  1/14 (7.14%)  1/14 (7.14%)  1/13 (7.69%)  2/13 (15.38%)  2/14 (14.29%) 
Dysphagia * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Gastric Ulcer * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Gastrooesophageal Reflux Disease * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Nausea * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Salivary Hypersecretion * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Toothache * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Vomiting * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
General disorders           
Chest Pain * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Feeling Cold * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Feeling Hot * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Hernia * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Infusion Site Pain * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Malaise * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Oedema Peripheral * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  2/14 (14.29%) 
Peripheral Swelling * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Vessel Puncture Site Pruritus * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Vessel Puncture Site Swelling * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Infections and infestations           
Asymptomatic Bacteriuria * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Bronchitis * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Cellulitis * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Conjunctivitis * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Herpes Zoster * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Hordeolum * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Influenza * 1  0/14 (0.00%)  1/14 (7.14%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Lower Respiratory Tract Infection * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Nasopharyngitis * 1  0/14 (0.00%)  1/14 (7.14%)  1/13 (7.69%)  2/13 (15.38%)  2/14 (14.29%) 
Pharyngitis * 1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Pneumonia * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Sinusitis * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Upper Respiratory Tract Infection * 1  1/14 (7.14%)  1/14 (7.14%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Urinary Tract Infection * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  2/14 (14.29%) 
Viral Upper Respiratory Tract Infection * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Injury, poisoning and procedural complications           
Contusion * 1  0/14 (0.00%)  1/14 (7.14%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Fall * 1  0/14 (0.00%)  1/14 (7.14%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Limb Injury * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Muscle Rupture * 1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Muscle Strain * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Palate Injury * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Skin Laceration * 1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Spinal Compression Fracture * 1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Investigations           
Alanine Aminotransferase Increased * 1  1/14 (7.14%)  1/14 (7.14%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Aspartate Aminotransferase Increased * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Bacterial Test * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Blood Creatine Phosphokinase Increased * 1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Blood Pressure Increased * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Carbohydrate Antigen 19-9 Increased * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Helicobacter Test Positive * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Liver Function Test Increased * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Lymphocyte Count Decreased * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Neutrophil Count Increased * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Neutrophil Percentage Increased * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Urine Analysis Abnormal * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Weight Decreased * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Metabolism and nutrition disorders           
Glucose Tolerance Impaired * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Hyperglycaemia * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Hypophosphataemia * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  2/13 (15.38%)  0/14 (0.00%) 
Arthritis * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Back Pain * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  1/13 (7.69%)  1/14 (7.14%) 
Muscle Spasms * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Muscle Twitching * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  1/14 (7.14%) 
Musculoskeletal Chest Pain * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Musculoskeletal Pain * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  2/13 (15.38%)  0/14 (0.00%) 
Neck Pain * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Rotator Cuff Syndrome * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Spinal Pain * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Nervous system disorders           
Dizziness * 1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  2/13 (15.38%)  0/14 (0.00%) 
Dysgeusia * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Headache * 1  1/14 (7.14%)  2/14 (14.29%)  1/13 (7.69%)  2/13 (15.38%)  1/14 (7.14%) 
Hypoaesthesia * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  2/13 (15.38%)  0/14 (0.00%) 
Mononeuropathy * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Myasthenia Gravis * 1  1/14 (7.14%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Presyncope * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Tension Headache * 1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Reproductive system and breast disorders           
Dysmenorrhoea * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Catarrh * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Cough * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Dysphonia * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Dyspnoea * 1  0/14 (0.00%)  0/14 (0.00%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Oropharyngeal Pain * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis Allergic * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Erythema * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Pruritus * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Rash * 1  0/14 (0.00%)  1/14 (7.14%)  0/13 (0.00%)  0/13 (0.00%)  3/14 (21.43%) 
Rash Erythematous * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Skin Swelling * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Swelling Face * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
Vascular disorders           
Brachiocephalic Vein Thrombosis * 1  0/14 (0.00%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Hypertension * 1  0/14 (0.00%)  2/14 (14.29%)  1/13 (7.69%)  0/13 (0.00%)  0/14 (0.00%) 
Hypotension * 1  1/14 (7.14%)  0/14 (0.00%)  0/13 (0.00%)  0/13 (0.00%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Limitations to this study include the small sample sizes of each treatment arm and the study activity disruption due to the COVID-19 pandemic, especially the missed Quantitative Myasthenia Gravis (QMG) assessments which hampered the analysis of the endpoint.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: DIRECTOR CLINICAL RESEARCH
Organization: Momenta Pharmaceuticals, Inc.
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03772587    
Other Study ID Numbers: MOM-M281-004
2018-002247-28 ( EudraCT Number )
First Submitted: December 10, 2018
First Posted: December 11, 2018
Results First Submitted: June 22, 2021
Results First Posted: October 27, 2021
Last Update Posted: October 27, 2021