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
Last Update Posted : September 9, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Generalized Myasthenia Gravis | Drug: M281 Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis |
Actual Study Start Date : | April 10, 2019 |
Actual Primary Completion Date : | May 6, 2020 |
Actual Study Completion Date : | June 25, 2020 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Group 1 |
Other: Placebo
Placebo administered as intravenous (IV) infusion |
Experimental: Group 2 |
Drug: M281
M281 administered as IV infusion |
Experimental: Group 3 |
Drug: M281
M281 administered as IV infusion |
Experimental: Group 4 |
Drug: M281
M281 administered as IV infusion |
Experimental: Group 5 |
Drug: M281
M281 administered as IV infusion |
- Number of Participants With Adverse Events [ Time Frame: Up to Day 113 ]
- Change From Baseline in the Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score at Day 57 [ Time Frame: Baseline; Day 57 ]
- Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57 [ Time Frame: Baseline; 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 [ Time Frame: Baseline; Day 57 ]
- Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or ≥8-point Improvement in Total MG-ADL Score [ Time Frame: Baseline to Day 57 ]
- Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score at Day 57 [ Time Frame: Baseline; Day 57 ]
- Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score at Day 57 [ Time Frame: Baseline; Day 57 ]
- Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 [ Time Frame: Baseline; Day 57 ]
- Change From Baseline in Total Serum IgG at Day 57 [ Time Frame: Baseline; Day 57 ]
- Change in Total MG-ADL Score Over Time After the Last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]
- Change in Total QMG Score Over Time After the Last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]
- Change in Total MG-QoL15r Score Over time After the last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]
- Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or ≥8-point Improvement in Total QMG Score Over Time After the Last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]
- Shift in MGFA Classification Over Time After the Last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]
- Change in Total Serum IgG Over Time After the Last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Participants must be ≥18 years of age with a documented history of Generalized Myasthenia Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, and no history of any neurologic disorder other than MG that might interfere with the accuracy of study assessments.
Additional, more specific criteria are defined in the protocol.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772587

Study Director: | Momenta General Queries | Momenta Pharmaceuticals, Inc. |
Responsible Party: | Momenta Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT03772587 |
Other Study ID Numbers: |
MOM-M281-004 2018-002247-28 ( EudraCT Number ) |
First Posted: | December 11, 2018 Key Record Dates |
Last Update Posted: | September 9, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
M281 Generalized Myasthenia Gravis |
Muscle Weakness Myasthenia Gravis Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases |
Pathologic Processes Autoimmune Diseases of the Nervous System Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases |