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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

Primary Purpose

Generalized Myasthenia Gravis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
M281
Sponsored by
Momenta Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Myasthenia Gravis focused on measuring M281, Generalized Myasthenia Gravis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site
  • Momenta Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

M281

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug in this study.
Number of Participants With Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)
Number of participants with treatment-emergent AESIs were reported. Severe infections and hypoalbuminemia (Grade 3 or higher according to the Common Terminology Criteria for Adverse Events [CTCAE] v5.0) were considered as AESIs.
Number of Participants With Treatment-emergent Abnormal Vital Signs
Number of participants with treatment-emergent abnormal vital signs including pulse rate (less than or equal to [<=] 50 beats per minutes [bpm] with greater than or equal to [>=] 15 bpm decrease from baseline, >= 120 bpm with >=15 bpm increase from baseline), systolic blood pressure (SBP) (<= 90 millimeters of mercury [mmHg] with >= 20 mmHg decrease from baseline, >= 160 mmHg with >= 20 mmHg increase from baseline) and diastolic blood pressure (DBP) (<= 50 mmHg with >=15 mmHg decrease from baseline, >=100 mmHg with >=15 mmHg decrease from baseline) were reported.
Number of Participants With Abnormalities in Physical Examinations
Number of participants with abnormalities in physical examinations (abdomen, head, ears, eyes, nose, throat, and sinuses, lungs, neurological, skin, blood and lymphatic system, cardiovascular, chest, gastrointestinal, general appearance and musculoskeletal) were reported.
Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein
Change from baseline in chemistry laboratory parameters: albumin and protein were reported.
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen
Change from baseline in chemistry laboratory parameters: bicarbonate, calcium, chloride, cholesterol, glucose, phosphate, potassium, sodium, triglycerides, urate and urea nitrogen were reported.
Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase
Change from baseline in chemistry laboratory parameters alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.
Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin
Change from baseline in chemistry laboratory parameters: bilirubin, creatinine and direct bilirubin were reported.
Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell)
Change from baseline in erythrocytes (red blood cells) (hematology laboratory parameter) was reported.
Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Change from baseline in hematology laboratory parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes were reported.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Change from baseline in erythrocytes mean corpuscular hemoglobin (HGB) concentration (hematology laboratory parameter) were reported.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB)
Change from baseline in erythrocytes mean corpuscular HGB (hematology laboratory parameter) was reported.
Change From Baseline in Hematology Laboratory Parameter: Erythrocytes Mean Corpuscular Volume
Change from baseline in erythrocytes mean corpuscular volume (hematology laboratory parameter) was reported.
Change From Baseline in Hematology Laboratory Parameter: Hematocrit
Change from baseline in hematocrit (hematology laboratory parameter) was reported.
Change From Baseline in Hematology Laboratory Parameter: Hemoglobin
Change from baseline in hemoglobin (hematology laboratory parameter) was reported.
Change From Baseline in Urinalysis Laboratory Parameter: pH
Change from baseline in pH (urinalysis laboratory parameter) was reported.
Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity
Change from baseline in specific gravity (urinalysis laboratory parameter) was reported.
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values
Number of participants with treatment-emergent abnormal ECG values for variables including mean heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute [bpm], abnormally high refers greater than or equal to [>=] 120 bpm), PR interval (abnormally low refers to < 120 and abnormally high refers to >200 milliseconds [msec]), RR interval (abnormally low refers to <600 msec and abnormally high refers to >1200 msec) and QRS duration (abnormally > 120) were reported.
Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Number of participants with C-SSRS scores were reported. C-SSRS is a clinician-administered questionnaire designed to solicit occurrence, severity, and frequency of suicide-related ideation and behaviors. Total score ranges from 1 to 10, score of 0 was assigned (0="no event that can be assessed based on C-SSRS"). Higher total scores indicate greater severity. Maximum score assigned for each participant was summarized into one of 3 categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5): higher score indicates more suicidal ideation, suicidal behavior (6 to 10): higher score indicates more suicidal behavior. Suicidal ideation includes participants who did not have suicidal ideation or behavior at baseline and had suicidal ideation without behavior at some time point post-baseline. Suicidal behavior includes participants who did not have suicidal ideation or behavior at baseline and had suicidal behavior at some time point post-baseline (baseline=Day 1).
Number of Participants With Below/Above Normal Values of Coagulation Laboratory Parameter
Number of participants with at least one value above upper limit of normal (>ULN) or below the lower limit of normal (< LLN) value of coagulation parameters (activated partial thromboplastin time [APTT] and prothrombin time [PT]) were reported. The lab reference range for APTT is 25.1 to 36.5 seconds. The lab reference range for PT is 9.4 to 12.5 seconds.

Secondary Outcome Measures

Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time
The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
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 Over Time
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 over time were reported. MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time
The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time
The MG-QoL15r was used to assess the participant's limitations related to living with MG. It consists of 15 questions and each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over Time
The CGI-S scale is the clinician/physician's global assessment of participants illness severity of MG and is rated by answering on 8-point scale. Considering total clinical experience, participant is assessed on severity of illness according to: 0=not performed; 1=normal, not at all ill; 2=borderline illness; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. Higher scores indicated more severity of illness. Values of 0 (not assessed) were excluded from analysis. CGI-S permits global evaluation of participant's condition at given time.
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score
Number of participants with improvement of illness based on CGI-I scale score over time were reported. The CGI-I scale is the clinician/physician's global assessment of the change in severity of the patient's generalized myasthenia gravis (gMG) since starting this study. The rating is given on a 7-point scale with lower scores indicating greater improvement (1= Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 =Minimally worse; 6 = Much worse; 7 = Very much worse. Values of 0 (not assessed) were excluded from analysis. Higher score indicates more severity.
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time
Number of participants with change from baseline in MGFA classification score over time were reported. The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III).
Number of Participants With Anti-drug Antibodies (ADA) to Nipocalimab
Number of participants with ADA to nipocalimab were reported. The presence of ADA to nipocalimab in serum was determined by a sensitive and drug-tolerant electrochemiluminescence immunoassay (ECLIA) method.
Number of Participants With Neutralizing Antibodies (NAbs) to Nipocalimab
Number of participants with NAbs were reported. Neutralizing antibodies to nipocalimab were assessed using a non-cell based competitive ligand binding ECLIA assay.
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time
Change from baseline in serum immunoglobulin (Ig)G concentration over time was reported.

Full Information

First Posted
March 28, 2019
Last Updated
June 7, 2023
Sponsor
Momenta Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03896295
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was originally halted due to the COVID-19 pandemic. The study was later terminated prematurely as the participants will have the option to enter into an open-label extension portion of a planned future study. It was not due to safety concerns.
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
December 9, 2020 (Actual)
Study Completion Date
December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Momenta Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis
Keywords
M281, Generalized Myasthenia Gravis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M281
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
M281
Intervention Description
M281 injection administered as intravenous infusion
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
Number of participants with TEAEs were reported. An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as any AE occurring during or after the initiation of the first infusion of study drug in this study.
Time Frame
Up to 257 days post-baseline (Baseline is Day 1)
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Time Frame
Up to 257 days post-baseline
Title
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs)
Description
Number of participants with treatment-emergent AESIs were reported. Severe infections and hypoalbuminemia (Grade 3 or higher according to the Common Terminology Criteria for Adverse Events [CTCAE] v5.0) were considered as AESIs.
Time Frame
Up to 257 days post-baseline
Title
Number of Participants With Treatment-emergent Abnormal Vital Signs
Description
Number of participants with treatment-emergent abnormal vital signs including pulse rate (less than or equal to [<=] 50 beats per minutes [bpm] with greater than or equal to [>=] 15 bpm decrease from baseline, >= 120 bpm with >=15 bpm increase from baseline), systolic blood pressure (SBP) (<= 90 millimeters of mercury [mmHg] with >= 20 mmHg decrease from baseline, >= 160 mmHg with >= 20 mmHg increase from baseline) and diastolic blood pressure (DBP) (<= 50 mmHg with >=15 mmHg decrease from baseline, >=100 mmHg with >=15 mmHg decrease from baseline) were reported.
Time Frame
Up to 257 days post-baseline
Title
Number of Participants With Abnormalities in Physical Examinations
Description
Number of participants with abnormalities in physical examinations (abdomen, head, ears, eyes, nose, throat, and sinuses, lungs, neurological, skin, blood and lymphatic system, cardiovascular, chest, gastrointestinal, general appearance and musculoskeletal) were reported.
Time Frame
Week 12
Title
Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein
Description
Change from baseline in chemistry laboratory parameters: albumin and protein were reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen
Description
Change from baseline in chemistry laboratory parameters: bicarbonate, calcium, chloride, cholesterol, glucose, phosphate, potassium, sodium, triglycerides, urate and urea nitrogen were reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase
Description
Change from baseline in chemistry laboratory parameters alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), creatine kinase, gamma glutamyl transferase, lactate dehydrogenase were reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin
Description
Change from baseline in chemistry laboratory parameters: bilirubin, creatinine and direct bilirubin were reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell)
Description
Change from baseline in erythrocytes (red blood cells) (hematology laboratory parameter) was reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Description
Change from baseline in hematology laboratory parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes were reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
Description
Change from baseline in erythrocytes mean corpuscular hemoglobin (HGB) concentration (hematology laboratory parameter) were reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB)
Description
Change from baseline in erythrocytes mean corpuscular HGB (hematology laboratory parameter) was reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Hematology Laboratory Parameter: Erythrocytes Mean Corpuscular Volume
Description
Change from baseline in erythrocytes mean corpuscular volume (hematology laboratory parameter) was reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Hematology Laboratory Parameter: Hematocrit
Description
Change from baseline in hematocrit (hematology laboratory parameter) was reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Hematology Laboratory Parameter: Hemoglobin
Description
Change from baseline in hemoglobin (hematology laboratory parameter) was reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Urinalysis Laboratory Parameter: pH
Description
Change from baseline in pH (urinalysis laboratory parameter) was reported.
Time Frame
Baseline up to Week 12
Title
Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity
Description
Change from baseline in specific gravity (urinalysis laboratory parameter) was reported.
Time Frame
Baseline up to Week 12
Title
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values
Description
Number of participants with treatment-emergent abnormal ECG values for variables including mean heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute [bpm], abnormally high refers greater than or equal to [>=] 120 bpm), PR interval (abnormally low refers to < 120 and abnormally high refers to >200 milliseconds [msec]), RR interval (abnormally low refers to <600 msec and abnormally high refers to >1200 msec) and QRS duration (abnormally > 120) were reported.
Time Frame
Up to 257 days post-baseline
Title
Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Scores
Description
Number of participants with C-SSRS scores were reported. C-SSRS is a clinician-administered questionnaire designed to solicit occurrence, severity, and frequency of suicide-related ideation and behaviors. Total score ranges from 1 to 10, score of 0 was assigned (0="no event that can be assessed based on C-SSRS"). Higher total scores indicate greater severity. Maximum score assigned for each participant was summarized into one of 3 categories: no suicidal ideation or behavior (0), suicidal ideation (1 to 5): higher score indicates more suicidal ideation, suicidal behavior (6 to 10): higher score indicates more suicidal behavior. Suicidal ideation includes participants who did not have suicidal ideation or behavior at baseline and had suicidal ideation without behavior at some time point post-baseline. Suicidal behavior includes participants who did not have suicidal ideation or behavior at baseline and had suicidal behavior at some time point post-baseline (baseline=Day 1).
Time Frame
Up to 257 days post-baseline
Title
Number of Participants With Below/Above Normal Values of Coagulation Laboratory Parameter
Description
Number of participants with at least one value above upper limit of normal (>ULN) or below the lower limit of normal (< LLN) value of coagulation parameters (activated partial thromboplastin time [APTT] and prothrombin time [PT]) were reported. The lab reference range for APTT is 25.1 to 36.5 seconds. The lab reference range for PT is 9.4 to 12.5 seconds.
Time Frame
Up to 257 days post-baseline
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time
Description
The MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Time Frame
Baseline up to Weeks 4, 8, 12, 24, End of treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)
Title
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 Over Time
Description
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 over time were reported. MG-ADL was used to assess the participant's MG symptom severity. It assesses eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, and eyelid droop) which were rated on a 4-point scale: 0 (no impairment) to 3 (severe impairment). The total score is the sum of the eight function scores and ranges from 0 to 24. Higher scores indicated greater symptom severity/difficulty in performing daily living activities.
Time Frame
Weeks 4, 8, 12, 24, End of treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)
Title
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over Time
Description
The QMG test was used to assess the participant's strength. The quantitative results of each of the 13 strength components were mapped to a 4-point scale where 0 equals to (=) none, 1= mild, 2= moderate and 3= severe. The total score is the sum of the 13 scale scores and ranges from 0 to 39. Higher scores indicated more severe impairment.
Time Frame
Baseline up to Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)
Title
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over Time
Description
The MG-QoL15r was used to assess the participant's limitations related to living with MG. It consists of 15 questions and each of the 15 questions were rated by the participant on a 3-point scale (0= Not at all, 1= somewhat, 2=very much) based on a recall period of "over the past few weeks". The total score is the sum of the 15 question scores and ranges from 0 to 30. Higher scores indicated more limitation.
Time Frame
Baseline up to Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)
Title
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over Time
Description
The CGI-S scale is the clinician/physician's global assessment of participants illness severity of MG and is rated by answering on 8-point scale. Considering total clinical experience, participant is assessed on severity of illness according to: 0=not performed; 1=normal, not at all ill; 2=borderline illness; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. Higher scores indicated more severity of illness. Values of 0 (not assessed) were excluded from analysis. CGI-S permits global evaluation of participant's condition at given time.
Time Frame
Baseline up to Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)
Title
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score
Description
Number of participants with improvement of illness based on CGI-I scale score over time were reported. The CGI-I scale is the clinician/physician's global assessment of the change in severity of the patient's generalized myasthenia gravis (gMG) since starting this study. The rating is given on a 7-point scale with lower scores indicating greater improvement (1= Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 =Minimally worse; 6 = Much worse; 7 = Very much worse. Values of 0 (not assessed) were excluded from analysis. Higher score indicates more severity.
Time Frame
Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)
Title
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time
Description
Number of participants with change from baseline in MGFA classification score over time were reported. The MGFA was used to assess the participant's MG severity. MGFA classification identifies the subgroup participants with MG who share distinct clinical features or severity of disease: Class I (ocular MG), classes II, III and IV generalized MG with mild, moderate and severe disease, respectively; Class V MG crisis. Separate subclasses under classes II, III and IV are designed: "a" if the predominant weakness is affecting limb/axial weakness or both; subclass "b" if the predominant weakness is affecting oropharyngeal or respiratory muscles or both. In the MGFA classification, lower roman numerals mean less severity. Changes in MGFA classification (regardless of subclass) are categorized as "Improved" (example, III to II), "Same" (example, II to II), or "Worsened" (example, II to III).
Time Frame
Weeks 8, 24 and End of Treatment (EoT) (up to 253 days post-baseline)
Title
Number of Participants With Anti-drug Antibodies (ADA) to Nipocalimab
Description
Number of participants with ADA to nipocalimab were reported. The presence of ADA to nipocalimab in serum was determined by a sensitive and drug-tolerant electrochemiluminescence immunoassay (ECLIA) method.
Time Frame
Up to 257 days post-baseline
Title
Number of Participants With Neutralizing Antibodies (NAbs) to Nipocalimab
Description
Number of participants with NAbs were reported. Neutralizing antibodies to nipocalimab were assessed using a non-cell based competitive ligand binding ECLIA assay.
Time Frame
Up to 257 days post-baseline
Title
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time
Description
Change from baseline in serum immunoglobulin (Ig)G concentration over time was reported.
Time Frame
Baseline to Weeks 2, 4, 8, 12, 24, up to 253 days post-baseline, up to 257 days post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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, 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.
Facility Information:
Facility Name
Momenta Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Momenta Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Momenta Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Momenta Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Momenta Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Momenta Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Momenta Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Momenta Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Momenta Investigational Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Momenta Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Momenta Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Momenta Investigational Site
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Momenta Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Momenta Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Momenta Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Momenta Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08550
Country
United States
Facility Name
Momenta Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Momenta Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Momenta Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Momenta Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Momenta Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Momenta Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Momenta Investigational Site
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38106
Country
United States
Facility Name
Momenta Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Momenta Investigational Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Momenta Investigational Site
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Momenta Investigational Site
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Momenta Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Momenta Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Momenta Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Momenta Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Momenta Investigational Site
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Momenta Investigational Site
City
Gottingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Momenta Investigational Site
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Momenta Investigational Site
City
Gummersbach
ZIP/Postal Code
51643
Country
Germany
Facility Name
Momenta Investigational Site
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Momenta Investigational Site
City
Cefalu
ZIP/Postal Code
90015
Country
Italy
Facility Name
Momenta Investigational Site
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
Momenta Investigational Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Momenta Investigational Site
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Momenta Investigational Site
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Momenta Investigational Site
City
Warsaw
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Momenta Investigational Site
City
Warsaw
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Momenta Investigational Site
City
Barcelona
State/Province
Catalan
ZIP/Postal Code
08035
Country
Spain
Facility Name
Momenta Investigational Site
City
Barcelona
State/Province
Catalan
ZIP/Postal Code
08041
Country
Spain
Facility Name
Momenta Investigational Site
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Facility Name
Momenta Investigational Site
City
L'hospitalet De Llobregat
State/Province
Cataluna
ZIP/Postal Code
08907
Country
Spain
Facility Name
Momenta Investigational Site
City
San Sebastian
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Momenta Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Momenta Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Momenta Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Momenta Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Momenta Investigational Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Momenta Investigational Site
City
Sheffield
ZIP/Postal Code
S11 9NE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis

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