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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

NCT ID: NCT03896295

Last Updated: 2023-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-06

Study Completion Date

2020-12-09

Brief Summary

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The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG)

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Detailed Description

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Conditions

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Generalized Myasthenia Gravis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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M281

Group Type EXPERIMENTAL

M281

Intervention Type DRUG

M281 injection administered as intravenous infusion

Interventions

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M281

M281 injection administered as intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Momenta Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Momenta Investigational Site

Phoenix, Arizona, United States

Site Status

Momenta Investigational Site

Los Angeles, California, United States

Site Status

Momenta Investigational Site

Orange, California, United States

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Momenta Investigational Site

Stanford, California, United States

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Momenta Investigational Site

Aurora, Colorado, United States

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Momenta Investigational Site

New Haven, Connecticut, United States

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Momenta Investigational Site

Boca Raton, Florida, United States

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Momenta Investigational Site

Maitland, Florida, United States

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Momenta Investigational Site

Port Charlotte, Florida, United States

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Momenta Investigational Site

St. Petersburg, Florida, United States

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Momenta Investigational Site

Augusta, Georgia, United States

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Momenta Investigational Site

Fairway, Kansas, United States

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Momenta Investigational Site

Boston, Massachusetts, United States

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Momenta Investigational Site

Boston, Massachusetts, United States

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Momenta Investigational Site

Boston, Massachusetts, United States

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Momenta Investigational Site

New Brunswick, New Jersey, United States

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Momenta Investigational Site

New York, New York, United States

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Momenta Investigational Site

Charlotte, North Carolina, United States

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Momenta Investigational Site

Durham, North Carolina, United States

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Momenta Investigational Site

Raleigh, North Carolina, United States

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Momenta Investigational Site

Cincinnati, Ohio, United States

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Momenta Investigational Site

Columbus, Ohio, United States

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Momenta Investigational Site

Cordova, Tennessee, United States

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Momenta Investigational Site

Austin, Texas, United States

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Momenta Investigational Site

Round Rock, Texas, United States

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Momenta Investigational Site

Leuven, Vlaams Brabant, Belgium

Site Status

Momenta Investigational Site

Antwerp, , Belgium

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Momenta Investigational Site

Brussels, , Belgium

Site Status

Momenta Investigational Site

Edmonton, Alberta, Canada

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Momenta Investigational Site

London, Ontario, Canada

Site Status

Momenta Investigational Site

Toronto, Ontario, Canada

Site Status

Momenta Investigational Site

Québec, Quebec, Canada

Site Status

Momenta Investigational Site

Göttingen, Lower Saxony, Germany

Site Status

Momenta Investigational Site

Düsseldorf, , Germany

Site Status

Momenta Investigational Site

Gummersbach, , Germany

Site Status

Momenta Investigational Site

Münster, , Germany

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Momenta Investigational Site

Cefalù, , Italy

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Momenta Investigational Site

Messina, , Italy

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Momenta Investigational Site

Milan, , Italy

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Momenta Investigational Site

Krakow, , Poland

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Momenta Investigational Site

Lodz, , Poland

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Momenta Investigational Site

Warsaw, , Poland

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Momenta Investigational Site

Warsaw, , Poland

Site Status

Momenta Investigational Site

Barcelona, Catalan, Spain

Site Status

Momenta Investigational Site

Barcelona, Catalan, Spain

Site Status

Momenta Investigational Site

Barcelona, Catalonia, Spain

Site Status

Momenta Investigational Site

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status

Momenta Investigational Site

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status

Momenta Investigational Site

Madrid, , Spain

Site Status

Momenta Investigational Site

Madrid, , Spain

Site Status

Momenta Investigational Site

Seville, , Spain

Site Status

Momenta Investigational Site

Valencia, , Spain

Site Status

Momenta Investigational Site

Birmingham, , United Kingdom

Site Status

Momenta Investigational Site

Sheffield, , United Kingdom

Site Status

Countries

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United States Belgium Canada Germany Italy Poland Spain United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-003618-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MOM-M281-005

Identifier Type: -

Identifier Source: org_study_id

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