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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.

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE August 6, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Number of Participants With Adverse Events [ Time Frame: Up to approximately 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03896295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
Official Title  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Generalized Myasthenia Gravis
Intervention  ICMJE Drug: M281
M281 injection administered as intravenous infusion
Study Arms  ICMJE Experimental: M281
Intervention: Drug: M281
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Momenta General Queries +1 617-491-9700 ClinicalTrialInfo@momentapharma.com
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896295
Other Study ID Numbers  ICMJE MOM-M281-005
2018-003618-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Momenta Pharmaceuticals, Inc.
Study Sponsor  ICMJE Momenta Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Momenta Pharmaceuticals, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP