Generalized Myasthenia GravisPhase 2NCT03896295
An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
A Phase 2 study testing M281 in people with Generalized Myasthenia Gravis, run by Momenta Pharmaceuticals, Inc. at 54 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Myasthenia Gravis
- What is being tested?
- M281
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 54 sitesin 8 countries
- Study dates
- 6 Aug 2019to 9 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
54 sites in 8 countries.
54 sites in 8 countries
United States25 sites
Momenta Investigational Site
Augusta, Georgia, 30912
Momenta Investigational Site
Aurora, Colorado, 80045
Momenta Investigational Site
Austin, Texas, 78756
Momenta Investigational Site
Boca Raton, Florida, 33487
Momenta Investigational Site
Boston, Massachusetts, 02114
Momenta Investigational Site
Boston, Massachusetts, 02115
Momenta Investigational Site
Boston, Massachusetts, 02215
Momenta Investigational Site
Charlotte, North Carolina, 28207
Momenta Investigational Site
Cincinnati, Ohio, 45267
Momenta Investigational Site
Columbus, Ohio, 43210
Momenta Investigational Site
Cordova, Tennessee, 38106
Momenta Investigational Site
Durham, North Carolina, 27710
Momenta Investigational Site
Fairway, Kansas, 66205
Momenta Investigational Site
Los Angeles, California, 90048
Momenta Investigational Site
Maitland, Florida, 32751
Momenta Investigational Site
New Brunswick, New Jersey, 08550
Momenta Investigational Site
New Haven, Connecticut, 06511
Momenta Investigational Site
New York, New York, 10021
Momenta Investigational Site
Orange, California, 92868
Momenta Investigational Site
Phoenix, Arizona, 85013
Momenta Investigational Site
Port Charlotte, Florida, 33952
Momenta Investigational Site
Raleigh, North Carolina, 27607
Momenta Investigational Site
Round Rock, Texas, 78681
Momenta Investigational Site
St. Petersburg, Florida, 33713
Momenta Investigational Site
Stanford, California, 94305
Spain9 sites
Momenta Investigational Site
Barcelona, Catalan, 08035
Momenta Investigational Site
Barcelona, Catalan, 08041
Momenta Investigational Site
Barcelona, Catalonia, 08036
Momenta Investigational Site
Donostia / San Sebastian, Gipuzkoa, 20014
Momenta Investigational Site
L'Hospitalet de Llobregat, Catalonia, 08907
Momenta Investigational Site
Madrid, 28007
Momenta Investigational Site
Madrid, 28040
Momenta Investigational Site
Seville, 41013
Momenta Investigational Site
Valencia, 46026
Canada4 sites
Momenta Investigational Site
Edmonton, Alberta, T6G 2G3
Momenta Investigational Site
London, Ontario, N6A 5A5
Momenta Investigational Site
Québec, Quebec, G1J 1Z4
Momenta Investigational Site
Toronto, Ontario, M5G 2C4
Germany4 sites
Momenta Investigational Site
Düsseldorf, 40225
Momenta Investigational Site
Göttingen, Lower Saxony, 37075
Momenta Investigational Site
Gummersbach, 51643
Momenta Investigational Site
Münster, 48149
Poland4 sites
Momenta Investigational Site
Krakow, 31-505
Momenta Investigational Site
Lodz, 90-324
Momenta Investigational Site
Warsaw, 01-684
Momenta Investigational Site
Warsaw, 01-868
Belgium3 sites
Momenta Investigational Site
Antwerp, 2650
Momenta Investigational Site
Brussels, 1070
Momenta Investigational Site
Leuven, Vlaams Brabant, 3000
Italy3 sites
Momenta Investigational Site
Cefalù, 90015
Momenta Investigational Site
Messina, 98125
Momenta Investigational Site
Milan, 20133
United Kingdom2 sites
Momenta Investigational Site
Birmingham, B15 2TH
Momenta Investigational Site
Sheffield, S11 9NE
About this study
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
The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG)
- Conditions
- Generalized Myasthenia Gravis
- Being tested
- M281
- Keywords
- M281, Generalized Myasthenia Gravis
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M281Drug
M281 injection administered as intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| M281 | Experimental | Not described Receives: Drug: M281 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 257 days post-baseline (Baseline is Day 1)
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.
Measured: Up to 257 days post-baseline
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.
Measured: Up to 257 days post-baseline
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.
Measured: Up to 257 days post-baseline
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.
Measured: Week 12
Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein
Change from baseline in chemistry laboratory parameters: albumin and protein were reported.
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell)
Change from baseline in erythrocytes (red blood cells) (hematology laboratory parameter) was reported.
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
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.
Measured: Baseline up to Week 12
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (HGB)
Change from baseline in erythrocytes mean corpuscular HGB (hematology laboratory parameter) was reported.
Measured: Baseline up to Week 12
Change From Baseline in Hematology Laboratory Parameter: Erythrocytes Mean Corpuscular Volume
Change from baseline in erythrocytes mean corpuscular volume (hematology laboratory parameter) was reported.
Measured: Baseline up to Week 12
Change From Baseline in Hematology Laboratory Parameter: Hematocrit
Change from baseline in hematocrit (hematology laboratory parameter) was reported.
Measured: Baseline up to Week 12
Change From Baseline in Hematology Laboratory Parameter: Hemoglobin
Change from baseline in hemoglobin (hematology laboratory parameter) was reported.
Measured: Baseline up to Week 12
Change From Baseline in Urinalysis Laboratory Parameter: pH
Change from baseline in pH (urinalysis laboratory parameter) was reported.
Measured: Baseline up to Week 12
Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity
Change from baseline in specific gravity (urinalysis laboratory parameter) was reported.
Measured: Baseline up to Week 12
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.
Measured: Up to 257 days post-baseline
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).
Measured: Up to 257 days post-baseline
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.
Measured: Up to 257 days post-baseline
Secondary outcomes (10)
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.
Measured: 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)
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.
Measured: Weeks 4, 8, 12, 24, End of treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Weeks 4, 8, 12, 24, End of Treatment (EoT) (up to 253 days post-baseline), Follow-up (up to 257 days post-baseline)
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).
Measured: Weeks 8, 24 and End of Treatment (EoT) (up to 253 days post-baseline)
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.
Measured: Up to 257 days post-baseline
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.
Measured: Up to 257 days post-baseline
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time
Change from baseline in serum immunoglobulin (Ig)G concentration over time was reported.
Measured: Baseline to Weeks 2, 4, 8, 12, 24, up to 253 days post-baseline, up to 257 days post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start6 Aug 2019
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Generalized Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momenta Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896295
- Sponsor's protocol ID
- MOM-M281-005
- Other IDs
- 2018-003618-41, 2018
- Status last verified
- May 2023
- First submitted
- 28 Mar 2019
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03896295
- Acronym / sponsor ID
- MOM-M281-005
- Conditions
- Generalized Myasthenia Gravis
- Keywords
- M281, Generalized Myasthenia Gravis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Momenta Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Posted 16 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M281 | Experimental | Drug: M281 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M281M281 injection administered as intravenous infusion | Drug | M281 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 257 days post-baseline (Baseline is Day 1)
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)
Time frame: Up to 257 days post-baseline
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)
Time frame: Up to 257 days post-baseline
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
Time frame: Up to 257 days post-baseline
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
Time frame: Week 12
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
Time frame: Baseline up to Week 12
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
Time frame: Baseline up to Week 12
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
Time frame: Baseline up to Week 12
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
Time frame: Baseline up to Week 12
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)
Time frame: Baseline up to Week 12
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
Time frame: Baseline up to Week 12
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
Time frame: Baseline up to Week 12
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)
Time frame: Baseline up to Week 12
Change from baseline in erythrocytes mean corpuscular HGB (hematology laboratory parameter) was reported.
Change From Baseline in Hematology Laboratory Parameter: Erythrocytes Mean Corpuscular Volume
Time frame: Baseline up to Week 12
Change from baseline in erythrocytes mean corpuscular volume (hematology laboratory parameter) was reported.
Change From Baseline in Hematology Laboratory Parameter: Hematocrit
Time frame: Baseline up to Week 12
Change from baseline in hematocrit (hematology laboratory parameter) was reported.
Change From Baseline in Hematology Laboratory Parameter: Hemoglobin
Time frame: Baseline up to Week 12
Change from baseline in hemoglobin (hematology laboratory parameter) was reported.
Change From Baseline in Urinalysis Laboratory Parameter: pH
Time frame: Baseline up to Week 12
Change from baseline in pH (urinalysis laboratory parameter) was reported.
Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity
Time frame: Baseline up to Week 12
Change from baseline in specific gravity (urinalysis laboratory parameter) was reported.
Number of Participants With Treatment-emergent Abnormal Electrocardiograms (ECG) Values
Time frame: Up to 257 days post-baseline
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
Time frame: Up to 257 days post-baseline
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
Time frame: Up to 257 days post-baseline
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.
10 secondary outcomes
Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over 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)
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
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)
Change From Baseline in Total Quantitative Myasthenia Gravis (QMG) Score Over 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)
Change From Baseline in Total Revised Myasthenia Gravis Quality of Life - 15 Scale (MG-QoL15r) Score Over 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)
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Rating Score Over 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)
Number of Participants With Improvement of Illness Over Time Based on Clinical Global Impression of Improvement (CGI-I) Scale Score
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)
Number of Participants With Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Classification Score Over Time
Time frame: Weeks 8, 24 and End of Treatment (EoT) (up to 253 days post-baseline)
Number of Participants With Anti-drug Antibodies (ADA) to Nipocalimab
Time frame: Up to 257 days post-baseline
Number of Participants With Neutralizing Antibodies (NAbs) to Nipocalimab
Time frame: Up to 257 days post-baseline
Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time
Time frame: Baseline to Weeks 2, 4, 8, 12, 24, up to 253 days post-baseline, up to 257 days post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing M281 in people with Generalized Myasthenia Gravis, run by Momenta Pharmaceuticals, Inc. at 54 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Spain, Canada, Germany, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 257 days post-baseline (Baseline is Day 1)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.