An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
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| ClinicalTrials.gov Identifier: NCT03896295 |
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Recruitment Status :
Terminated
(Study was originally halted due to the COVID-19 pandemic. The study was later terminated prematurely as the participants will have the option to enter into an open-label extension portion of a planned future study. It was not due to safety concerns.)
First Posted : March 29, 2019
Last Update Posted : March 1, 2021
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Sponsor:
Momenta Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.
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Brief Summary:
The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Generalized Myasthenia Gravis | Drug: M281 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis |
| Actual Study Start Date : | August 6, 2019 |
| Actual Primary Completion Date : | June 22, 2020 |
| Actual Study Completion Date : | June 22, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Myasthenia gravis
MedlinePlus related topics:
Myasthenia Gravis
| Arm | Intervention/treatment |
|---|---|
| Experimental: M281 |
Drug: M281
M281 injection administered as intravenous infusion |
Primary Outcome Measures :
- Number of Participants With Adverse Events [ Time Frame: Up to approximately 1 year ]
Secondary Outcome Measures :
- Change From Baseline in the Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
- Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or ≥8-Point Improvement in Total MG-ADL Score Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
- Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
- Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
- Change From Baseline in Clinical Global Impression of Change (CGI-C) Ratings [ Time Frame: Baseline (Day 1) to approximately 1 year ]
- Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
- Number of participants with Anti-Drug Antibody (ADA) and Neutralizing ADA (nADA) Seroconversion Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
- Change From Baseline in Total Serum Immunoglobulin (Ig)G Concentrations Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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, previously participated in the MOM-281-004 study, had no major eligibility deviations or other major protocol deviations or not met any of the stopping criteria or discontinued study drug in the MOM-M281-004 study for any reason other than the need for rescue therapy as specified in the MOM-M281-004 study.
Additional, more specific criteria are defined in the protocol.
Information from the National Library of Medicine
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): NCT03896295
Locations
Show 54 study locations
Sponsors and Collaborators
Momenta Pharmaceuticals, Inc.
| Responsible Party: | Momenta Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT03896295 |
| Other Study ID Numbers: |
MOM-M281-005 2018-003618-41 ( EudraCT Number ) |
| First Posted: | March 29, 2019 Key Record Dates |
| Last Update Posted: | March 1, 2021 |
| Last Verified: | February 2021 |
| 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 |
Keywords provided by Momenta Pharmaceuticals, Inc.:
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M281 Generalized Myasthenia Gravis |
Additional relevant MeSH terms:
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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 |