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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Generalized Myasthenia Gravis Drug: M281 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 10, 2019
Actual Primary Completion Date : May 6, 2020
Actual Study Completion Date : June 25, 2020

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group 1 Other: Placebo
Placebo administered as intravenous (IV) infusion
Experimental: Group 2 Drug: M281
M281 administered as IV infusion
Experimental: Group 3 Drug: M281
M281 administered as IV infusion
Experimental: Group 4 Drug: M281
M281 administered as IV infusion
Experimental: Group 5 Drug: M281
M281 administered as IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: Up to Day 113 ]
  2. Change From Baseline in the Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score at Day 57 [ Time Frame: Baseline; Day 57 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score at Day 57 [ Time Frame: Baseline; Day 57 ]
  5. Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score at Day 57 [ Time Frame: Baseline; Day 57 ]
  6. Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57 [ Time Frame: Baseline; Day 57 ]
  7. Change From Baseline in Total Serum IgG at Day 57 [ Time Frame: Baseline; Day 57 ]
  8. Change in Total MG-ADL Score Over Time After the Last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]
  9. Change in Total QMG Score Over Time After the Last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]
  10. Change in Total MG-QoL15r Score Over time After the last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]
  11. 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 ]
  12. Shift in MGFA Classification Over Time After the Last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]
  13. Change in Total Serum IgG Over Time After the Last Dose [ Time Frame: Last dose (Day 57) to Day 113 ]

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, 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.

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): NCT03772587


Locations
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Sponsors and Collaborators
Momenta Pharmaceuticals, Inc.
Investigators
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Study Director: Momenta General Queries Momenta Pharmaceuticals, Inc.
More Information
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Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03772587    
Other Study ID Numbers: MOM-M281-004
2018-002247-28 ( EudraCT Number )
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 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
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases