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An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896295
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: M281 Drug: M281
M281 injection administered as intravenous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Up to approximately 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
  4. 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 ]
  5. Change From Baseline in Clinical Global Impression of Severity (CGI-S) Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
  6. Change From Baseline in Clinical Global Impression of Change (CGI-C) Ratings [ Time Frame: Baseline (Day 1) to approximately 1 year ]
  7. Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
  8. Number of participants with Anti-Drug Antibody (ADA) and Neutralizing ADA (nADA) Seroconversion Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]
  9. Change From Baseline in Total Serum Immunoglobulin (Ig)G Concentrations Over Time [ Time Frame: Baseline (Day 1) to approximately 1 year ]

Eligibility Criteria
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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.

Contacts and Locations
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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


Contacts
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Contact: Momenta General Queries +1 617-491-9700 ClinicalTrialInfo@momentapharma.com

Locations
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Sponsors and Collaborators
Momenta Pharmaceuticals, Inc.
More Information
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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: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Momenta Pharmaceuticals, Inc.:
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
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases