Clinical trial NCT03772587: A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Myasthenia Gravis
Keywords: M281
Generalized Myasthenia Gravis
Lead sponsor: Momenta Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
timeFrame: Up to Day 113
measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to Day 113
measure: Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
timeFrame: Up to Day 113
measure: Change From Baseline to Day 57 in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score
timeFrame: Baseline to Day 57
Secondary outcomes:
measure: Change From Baseline in Total MG-ADL Score as a Function of Total Serum Immunoglobulin G (IgG) at Day 57
timeFrame: Baseline and Day 57
measure: 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
timeFrame: Baseline and Day 57
measure: Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score as a Function of Total Serum IgG at Day 57
timeFrame: Baseline and Day 57
measure: Change From Baseline in Total QMG Score as a Response to Percent Change in Total Serum IgG, for Participants Positive for Anti-acetylcholine Receptor (Anti-AChR) Antibodies, at Day 57
timeFrame: Baseline and Day 57
measure: Number of Participants With a 2-, 3-, 4-, 5-, 6-, 7-, or Greater Than or Equal to (>=) 8-point Improvement in Total MG-ADL Score at Day 57
timeFrame: Day 57
measure: Change From Baseline in Total QMG Score at Day 57
timeFrame: Baseline and Day 57
measure: Number of Participants With a 3-, 4-, 5-, 6-, 7-, or >= 8-point Improvement in Total QMG Score at Day 57
timeFrame: Day 57
measure: Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 (MG-QoL-15r) Scale Score at Day 57
timeFrame: Baseline and Day 57
measure: Change From Baseline in Total Serum IgG at Day 57
timeFrame: Baseline and Day 57
measure: Change From Baseline in Total MG-ADL Score at Day 85 and Day 113
timeFrame: Baseline, Day 85 and Day 113
measure: Change From Baseline in Total QMG Score at Day 85 and Day 113
timeFrame: Baseline, Day 85 and Day 113
measure: Change From Baseline in Total MG-QoL15r Score at Day 85 and Day 113
timeFrame: Baseline, Day 85 and Day 113
measure: Number of Participants With Shift From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification at Day 57
timeFrame: Baseline and Day 57
measure: Number of Participants With Shift From Baseline in MGFA Classification to Day 113
timeFrame: Baseline to Day 113
measure: Change From Baseline in Total Serum IgG at Day 85 and Day 113
timeFrame: Baseline, Day 85 and Day 113
measure: Serum Concentrations of Nipocalimab
timeFrame: Baseline (Pre Infusion and Post Infusion), Day 15 (Pre Infusion), Day 29 (Pre Infusion), Day 43 (Pre Infusion), Day 57 (Pre Infusion and Post Infusion) and Day 85
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Momenta Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Momenta Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: Momenta Investigational Site
state: California
city: Orange
country: United States
facility: Momenta Investigational Site
state: California
city: Stanford
country: United States
facility: Momenta Investigational Site
state: California
city: Aurora
country: United States
facility: Momenta Investigational Site
state: Colorado
city: New Haven
country: United States
facility: Momenta Investigational Site
state: Connecticut
city: Boca Raton
country: United States
facility: Momenta Investigational Site
state: Florida
city: Maitland
country: United States
facility: Momenta Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: Momenta Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Momenta Investigational Site
state: Florida
city: Augusta
country: United States
facility: Momenta Investigational Site
state: Georgia
city: Meridian
country: United States
facility: Momenta Investigational Site
state: Idaho
city: Lake Barrington
country: United States
facility: Momenta Investigational Site
state: Illinois
city: Fairway
country: United States
facility: Momenta Investigational Site
state: Kansas
city: Boston
country: United States
facility: Momenta Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Momenta Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Momenta Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Momenta Investigational Site
state: Michigan
city: East Lansing
country: United States
facility: Momenta Investigational Site
state: Michigan
city: Columbia
country: United States
facility: Momenta Investigational Site
state: Missouri
city: New Brunswick
country: United States
facility: Momenta Investigational Site
state: New Jersey
city: New York
country: United States
facility: Momenta Investigational Site
state: New York
city: Charlotte
country: United States
facility: Momenta Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Momenta Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Momenta Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Momenta Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Momenta Investigational Site
state: Ohio
city: Cordova
country: United States
facility: Momenta Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Momenta Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Momenta Investigational Site
state: Texas
city: Leuven
country: Belgium
facility: Momenta Investigational Site
state: Vlaams Brabant
city: Antwerp
country: Belgium
facility: Momenta Investigational Site
city: Bruxelles
country: Belgium
facility: Momenta Investigational Site
city: Edmonton
country: Canada
facility: Momenta Investigational Site
state: Alberta
city: London
country: Canada
facility: Momenta Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Momenta Investigational Site
state: Ontario
city: Quebec City
country: Canada
facility: Momenta Investigational Site
state: Quebec
city: Gottingen
country: Germany
facility: Momenta Investigational Site
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Momenta Investigational Site
city: Gummersbach
country: Germany
facility: Momenta Investigational Site
city: Munster
country: Germany
facility: Momenta Investigational Site
city: Cefalu
country: Italy
facility: Momenta Investigational Site
city: Messina
country: Italy
facility: Momenta Investigational Site
city: Milano
country: Italy
facility: Momenta Investigational Site
city: Krakow
country: Poland
facility: Momenta Investigational Site
city: Lodz
country: Poland
facility: Momenta Investigational Site
city: Warsaw
country: Poland
facility: Momenta Investigational Site
city: Warsaw
country: Poland
facility: Momenta Investigational Site
city: Barcelona
country: Spain
facility: Momenta Investigational Site
state: Catalan
city: Barcelona
country: Spain
facility: Momenta Investigational Site
state: Catalan
city: Badalona
country: Spain
facility: Momenta Investigational Site
state: Cataluna
city: L'hospitalet De Llobregat
country: Spain
facility: Momenta Investigational Site
state: Cataluna
city: San Sebastian
country: Spain
facility: Momenta Investigational Site
state: Gipuzkoa
city: Madrid
country: Spain
facility: Momenta Investigational Site
city: Madrid
country: Spain
facility: Momenta Investigational Site
city: Sevilla
country: Spain
facility: Momenta Investigational Site
city: Valencia
country: Spain
facility: Momenta Investigational Site
city: Birmingham
country: United Kingdom
facility: Momenta Investigational Site
city: Sheffield
country: United Kingdom
facility: Momenta Investigational Site
city: Southampton
country: United Kingdom
facility: Momenta Investigational Site
Study officials:
affiliation: Momenta Pharmaceuticals, Inc.
name: Momenta General Queries
role: STUDY_DIRECTOR
References: