Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772587
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE April 10, 2019
Actual Primary Completion Date May 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • 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 ]
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 A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Generalized Myasthenia Gravis
Intervention  ICMJE
  • Drug: M281
    M281 administered as IV infusion
  • Other: Placebo
    Placebo administered as intravenous (IV) infusion
Study Arms  ICMJE
  • Placebo Comparator: Group 1
    Intervention: Other: Placebo
  • Experimental: Group 2
    Intervention: Drug: M281
  • Experimental: Group 3
    Intervention: Drug: M281
  • Experimental: Group 4
    Intervention: Drug: M281
  • Experimental: Group 5
    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 Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2020)
69
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)
60
Actual Study Completion Date  ICMJE June 25, 2020
Actual Primary Completion Date May 6, 2020   (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, 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.

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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03772587
Other Study ID Numbers  ICMJE MOM-M281-004
2018-002247-28 ( 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
Study Director: Momenta General Queries Momenta Pharmaceuticals, Inc.
PRS Account Momenta Pharmaceuticals, Inc.
Verification Date September 2020

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