A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
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ClinicalTrials.gov Identifier: NCT03772587 |
Recruitment Status :
Completed
First Posted : December 11, 2018
Results First Posted : October 27, 2021
Last Update Posted : October 27, 2021
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Sponsor:
Momenta Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.
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Study Type | Interventional |
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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 |
Participant Flow
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) |
---|---|---|---|---|---|
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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 |
Baseline Characteristics
Arm/Group Title | Placebo | Nipocalimab 5 Milligrams/Kilogram (mg/kg) | Nipocalimab 30 mg/kg | Nipocalimab 60 mg/kg | Nipocalimab 60 mg/kg (Q2W) | Total | |
---|---|---|---|---|---|---|---|
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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 | |
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Intent-to-treat (ITT) population included all randomized participants.
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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%
|
Outcome Measures
Adverse Events
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.
More Information
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
Name/Title: | DIRECTOR CLINICAL RESEARCH |
Organization: | Momenta Pharmaceuticals, Inc. |
Phone: | 844-434-4210 |
EMail: | ClinicalTrialDisclosure@its.jnj.com |
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 |