Trial · NCT03896295
An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
NCT03896295, Phase 2, Terminated, Momenta Pharmaceuticals, Inc.; results first posted 2022-02-16
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis. Trials, record NCT03896295. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03896295
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
- NCT number
- NCT03896295
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Momenta Pharmaceuticals, Inc.
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- M281
- First posted
- 2019-03-29
- Last updated
- 2023-06-27
- Other registries' IDs
- eudract:2018-003618-41
- Results first posted
- 2022-02-16
- Limitations and caveats
Study was originally halted due to the COVID-19 pandemic. The study was later terminated prematurely due to the continuing COVID-19 pandemic, and because 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.
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | 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. |
| Primary | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) | 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. |
| Primary | Number of Participants With Treatment-emergent Abnormal Vital Signs | 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. |
| Primary | Number of Participants With Abnormalities in Physical Examinations | 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. |
| Primary | Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein | Baseline up to Week 12 | Change from baseline in chemistry laboratory parameters: albumin and protein were reported. |
| Primary | Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen | 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. |
| Primary | Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | 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. |
| Primary | Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin | Baseline up to Week 12 | Change from baseline in chemistry laboratory parameters: bilirubin, creatinine and direct bilirubin were reported. |
| Primary | Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell) | Baseline up to Week 12 | Change from baseline in erythrocytes (red blood cells) (hematology laboratory parameter) was reported. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 257 days post-baseline (Baseline is Day 1) | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) | Up to 257 days post-baseline | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) | Up to 257 days post-baseline | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Abnormal Vital Signs | Up to 257 days post-baseline | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in Physical Examinations | Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Chemistry Laboratory Parameters: Albumin and Protein | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM). As per planned analysis, data is reported for individual arms and for all (total) participants both. | grams per liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium, Sodium, Triglycerides, Urate and Urea Nitrogen | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | millimoles per liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase, Lactate Dehydrogenase | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both. | units per liter (U/L) | MEAN |
| PRIMARY | Change From Baseline in Chemistry Laboratory Parameters: Bilirubin, Creatinine and Direct Bilirubin | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories. As per planned analysis, data is reported for individual arms and for all (total) participants both. | micromoles per liter (micromol/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Laboratory Parameter: Erythrocytes (Red Blood Cell) | Baseline up to Week 12 | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM. As per planned analysis, data is reported for individual arms and for all (total) participants both. | 10^12 cells count per Liter | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group536
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo-Nipocalimab | 4 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Nipocalimab-Nipocalimab | 18 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Nipocalimab (All Participants) | 22 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Placebo-Nipocalimab | 1 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Nipocalimab-Nipocalimab | 4 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | Nipocalimab (All Participants) | 5 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) | Placebo-Nipocalimab | 1 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) | Nipocalimab-Nipocalimab | 1 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESIs) | Nipocalimab (All Participants) | 2 | Participants | ||
| Number of Participants With Treatment-emergent Abnormal Vital Signs | Placebo-Nipocalimab | Pulse rate: <=50 bpm with >=15 bpm decrease from baseline | 0 | Participants |
1 to 10 of 536Source ClinicalTrials.gov
See all 536 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo-Nipocalimab | 7 | |
| Overall Study | STARTED | Nipocalimab-Nipocalimab | 30 | |
| Overall Study | COMPLETED | Placebo-Nipocalimab | 0 | |
| Overall Study | COMPLETED | Nipocalimab-Nipocalimab | 0 | |
| Overall Study | NOT COMPLETED | Placebo-Nipocalimab | 7 | |
| Overall Study | NOT COMPLETED | Nipocalimab-Nipocalimab | 30 |
Source ClinicalTrials.gov
Adverse events114
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Placebo-Nipocalimab | 0 | 7 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Nipocalimab-Nipocalimab | 1 | 30 | |
| other | Vertigo Positional | Ear and labyrinth disorders | Placebo-Nipocalimab | 1 | 7 | |
| other | Vertigo Positional | Ear and labyrinth disorders | Nipocalimab-Nipocalimab | 0 | 30 | |
| other | Conjunctival Haemorrhage | Eye disorders | Placebo-Nipocalimab | 0 | 7 | |
| other | Conjunctival Haemorrhage | Eye disorders | Nipocalimab-Nipocalimab | 1 | 30 | |
| other | Conjunctival Hyperaemia | Eye disorders | Placebo-Nipocalimab | 0 | 7 | |
| other | Conjunctival Hyperaemia | Eye disorders | Nipocalimab-Nipocalimab | 1 | 30 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Nipocalimab | 0 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | Nipocalimab-Nipocalimab | 2 | 30 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-Nipocalimab | 0 | 7 |
| Total, all-cause mortality | Nipocalimab-Nipocalimab | 1 | 30 |
| Total, other adverse events | Placebo-Nipocalimab | 4 | 7 |
| Total, other adverse events | Nipocalimab-Nipocalimab | 17 | 30 |
| Total, serious adverse events | Placebo-Nipocalimab | 1 | 7 |
| Total, serious adverse events | Nipocalimab-Nipocalimab | 4 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nipocalimab-Nipocalimab vs Placebo-Nipocalimab: deaths from any cause | Trial comparisons |
| Nipocalimab-Nipocalimab vs Placebo-Nipocalimab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03896295
GET https://conductscience.org/api/trials/v1/NCT03896295/registered?page=2