Trial · NCT03772587

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

NCT03772587, Phase 2, Completed, Momenta Pharmaceuticals, Inc.; results first posted 2021-10-27

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis. Trials, record NCT03772587. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03772587

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
NCT number: NCT03772587
Status: Completed
Phases: Phase 2
Enrollment: 68 participants, actual
Lead sponsor: Momenta Pharmaceuticals, Inc.
Conditions: Generalized Myasthenia Gravis
Interventions: M281, Placebo
First posted: 2018-12-11
Last updated: 2023-06-27
Other registries' IDs: eudract:2018-002247-28
Results first posted: 2021-10-27
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	Up to Day 113	An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE are defined as any AE occurring during or after the initiation of the first infusion of study drug.
Primary	Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	Up to Day 113	An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Primary	Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)	Up to Day 113	An AE is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug. For this study, any common terminology criteria for adverse events (CTCAE) Grade 3 or higher event of severe infection or hypoalbuminemia was considered as AESI.
Primary	Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score	Baseline to Day 57	The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Secondary	Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57	Baseline and Day 57	Estimate of additional change from baseline in MG-ADL total score for every 10 percent (%) additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57. The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Secondary	Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57	Baseline and Day 57	Estimate of additional change from baseline in MG-ADL total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in MG-ADL total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The MG-ADL was used to assess participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). Total score is sum of eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Secondary	Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57	Baseline and Day 57	Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Secondary	Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57	Baseline and Day 57	Estimate of additional change from baseline in QMG total score for every 10% additional reduction in IgG based on a linear regression of change from baseline in QMG total score on percent reduction in IgG at Day 57 in anti-AChR positive participants. The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Secondary	Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57	Day 57	The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Secondary	Change From Baseline in Total QMG Score at Day 57	Baseline and Day 57	The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	Up to Day 113	The safety population included all participants who received any amount of nipocalimab or placebo.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	Up to Day 113	The safety population included all participants who received any amount of nipocalimab or placebo.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)	Up to Day 113	The safety population included all participants who received any amount of nipocalimab or placebo.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score	Baseline to Day 57	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).	score on a scale	MEAN
SECONDARY	Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57	Baseline and Day 57	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.	score on a scale per 10% IgG reduction	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total MG-ADL Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57	Baseline and Day 57	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.	score on a scale per 10% IgG reduction	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57	Baseline and Day 57	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.	score on a scale per 10% IgG reduction	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57	Baseline and Day 57	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.	score on a scale per 10% IgG reduction	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57	Day 57	Population analyzed included ITT participants for whom data was available at Day 57.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Total QMG Score at Day 57	Baseline and Day 57	ITT population included all randomized participants. Here 'N' (number of participants analyzed) included all participants who were evaluated for this OM.	score on a scale	MEAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group206

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	Placebo	11	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	Nipocalimab 5 Milligrams/Kilogram (mg/kg)	12	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	Nipocalimab 30 mg/kg	9	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	Nipocalimab 60 mg/kg	12	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability	Nipocalimab 60 mg/kg (Q2W)	12	Participants
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	Placebo	2	Participants
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	Nipocalimab 5 mg/kg	0	Participants
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	Nipocalimab 30 mg/kg	1	Participants
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	Nipocalimab 60 mg/kg	0	Participants
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)	Nipocalimab 60 mg/kg (Q2W)	0	Participants

1 to 10 of 206Source ClinicalTrials.gov

See all 206 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	14
Overall Study	STARTED	Nipocalimab (M281) 5 Milligrams/Kilogram (mg/kg)	14
Overall Study	STARTED	Nipocalimab 30 mg/kg	13
Overall Study	STARTED	Nipocalimab 60 mg/kg	13
Overall Study	STARTED	Nipocalimab 60 mg/kg (Q2W)	14
Overall Study	COMPLETED	Placebo	13
Overall Study	COMPLETED	Nipocalimab (M281) 5 Milligrams/Kilogram (mg/kg)	14
Overall Study	COMPLETED	Nipocalimab 30 mg/kg	12
Overall Study	COMPLETED	Nipocalimab 60 mg/kg	12
Overall Study	COMPLETED	Nipocalimab 60 mg/kg (Q2W)	14

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events525

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Iron Deficiency Anaemia	Blood and lymphatic system disorders	Placebo	1	14
other	Iron Deficiency Anaemia	Blood and lymphatic system disorders	Nipocalimab 5 Milligrams/Kilogram (mg/kg)	0	14
other	Iron Deficiency Anaemia	Blood and lymphatic system disorders	Nipocalimab 30 mg/kg	0	13
other	Iron Deficiency Anaemia	Blood and lymphatic system disorders	Nipocalimab 60 mg/kg	1	13
other	Iron Deficiency Anaemia	Blood and lymphatic system disorders	Nipocalimab 60 mg/kg (Q2W)	0	14
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	0	14
other	Thrombocytopenia	Blood and lymphatic system disorders	Nipocalimab 5 Milligrams/Kilogram (mg/kg)	0	14
other	Thrombocytopenia	Blood and lymphatic system disorders	Nipocalimab 30 mg/kg	0	13
other	Thrombocytopenia	Blood and lymphatic system disorders	Nipocalimab 60 mg/kg	0	13
other	Thrombocytopenia	Blood and lymphatic system disorders	Nipocalimab 60 mg/kg (Q2W)	1	14

1 to 10 of 525Source ClinicalTrials.gov

See all 525 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	14
Total, all-cause mortality	Nipocalimab 5 Milligrams/Kilogram (mg/kg)	0	14
Total, all-cause mortality	Nipocalimab 30 mg/kg	0	13
Total, all-cause mortality	Nipocalimab 60 mg/kg	0	13
Total, all-cause mortality	Nipocalimab 60 mg/kg (Q2W)	0	14
Total, other adverse events	Placebo	10	14
Total, other adverse events	Nipocalimab 5 Milligrams/Kilogram (mg/kg)	12	14
Total, other adverse events	Nipocalimab 30 mg/kg	8	13
Total, other adverse events	Nipocalimab 60 mg/kg	12	13
Total, other adverse events	Nipocalimab 60 mg/kg (Q2W)	12	14

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38165333	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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