An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
Sponsor
Momenta Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03896295
Collaborator
(none)
37
54
1
16.1
0.7
0
Study Details
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Aug 6, 2019
Actual Primary Completion Date
:
Dec 9, 2020
Actual Study Completion Date
:
Dec 9, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: M281
|
Drug: M281
M281 injection administered as intravenous infusion
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Change From Baseline in Hematology Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes [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 [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) [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 [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 [Baseline up to Week 12]
Change from baseline in hematocrit (hematology laboratory parameter) was reported.
- Change From Baseline in Hematology Laboratory Parameter: Hemoglobin [Baseline up to Week 12]
Change from baseline in hemoglobin (hematology laboratory parameter) was reported.
- Change From Baseline in Urinalysis Laboratory Parameter: pH [Baseline up to Week 12]
Change from baseline in pH (urinalysis laboratory parameter) was reported.
- Change From Baseline in Urinalysis Laboratory Parameter: Specific Gravity [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 [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 [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 [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.
Secondary Outcome Measures
- Change From Baseline in Total Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score Over Time [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)]
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 [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 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 [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)]
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 [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)]
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 [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)]
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 [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 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 [Weeks 8, 24 and End of Treatment (EoT) (up to 253 days post-baseline)]
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 [Up to 257 days post-baseline]
Number of participants with ADA to nipocalimab were reported.
- Number of Participants With Neutralizing Antibodies (NAbs) to Nipocalimab [Up to 257 days post-baseline]
Number of participants with NAbs were reported. Samples positive for ADA in this study could not be further analyzed for neutralizing antibodies (NAbs) to nipocalimab due to limited number of participants developed ADA.
- Change From Baseline in Serum Immunoglobulin (Ig)G Concentration Over Time [Baseline to Weeks 2, 4, 8, 12, 24, up to 253 days post-baseline, up to 257 days post-baseline]
Change from baseline in serum immunoglobulin (Ig)G concentration over time was reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Momenta Investigational Site | Phoenix | Arizona | United States | 85013 |
| 2 | Momenta Investigational Site | Los Angeles | California | United States | 90048 |
| 3 | Momenta Investigational Site | Orange | California | United States | 92868 |
| 4 | Momenta Investigational Site | Stanford | California | United States | 94305 |
| 5 | Momenta Investigational Site | Aurora | Colorado | United States | 80045 |
| 6 | Momenta Investigational Site | New Haven | Connecticut | United States | 06511 |
| 7 | Momenta Investigational Site | Boca Raton | Florida | United States | 33487 |
| 8 | Momenta Investigational Site | Maitland | Florida | United States | 32751 |
| 9 | Momenta Investigational Site | Port Charlotte | Florida | United States | 33952 |
| 10 | Momenta Investigational Site | Saint Petersburg | Florida | United States | 33713 |
| 11 | Momenta Investigational Site | Augusta | Georgia | United States | 30912 |
| 12 | Momenta Investigational Site | Fairway | Kansas | United States | 66205 |
| 13 | Momenta Investigational Site | Boston | Massachusetts | United States | 02114 |
| 14 | Momenta Investigational Site | Boston | Massachusetts | United States | 02115 |
| 15 | Momenta Investigational Site | Boston | Massachusetts | United States | 02215 |
| 16 | Momenta Investigational Site | New Brunswick | New Jersey | United States | 08550 |
| 17 | Momenta Investigational Site | New York | New York | United States | 10021 |
| 18 | Momenta Investigational Site | Charlotte | North Carolina | United States | 28207 |
| 19 | Momenta Investigational Site | Durham | North Carolina | United States | 27710 |
| 20 | Momenta Investigational Site | Raleigh | North Carolina | United States | 27607 |
| 21 | Momenta Investigational Site | Cincinnati | Ohio | United States | 45267 |
| 22 | Momenta Investigational Site | Columbus | Ohio | United States | 43210 |
| 23 | Momenta Investigational Site | Cordova | Tennessee | United States | 38106 |
| 24 | Momenta Investigational Site | Austin | Texas | United States | 78756 |
| 25 | Momenta Investigational Site | Round Rock | Texas | United States | 78681 |
| 26 | Momenta Investigational Site | Leuven | Vlaams Brabant | Belgium | 3000 |
| 27 | Momenta Investigational Site | Antwerp | Belgium | 2650 | |
| 28 | Momenta Investigational Site | Bruxelles | Belgium | 1070 | |
| 29 | Momenta Investigational Site | Edmonton | Alberta | Canada | T6G 2G3 |
| 30 | Momenta Investigational Site | London | Ontario | Canada | N6A 5A5 |
| 31 | Momenta Investigational Site | Toronto | Ontario | Canada | M5G 2C4 |
| 32 | Momenta Investigational Site | Quebec City | Quebec | Canada | G1J 1Z4 |
| 33 | Momenta Investigational Site | Gottingen | Niedersachsen | Germany | 37075 |
| 34 | Momenta Investigational Site | Dusseldorf | Germany | 40225 | |
| 35 | Momenta Investigational Site | Gummersbach | Germany | 51643 | |
| 36 | Momenta Investigational Site | Munster | Germany | 48149 | |
| 37 | Momenta Investigational Site | Cefalu | Italy | 90015 | |
| 38 | Momenta Investigational Site | Messina | Italy | 98125 | |
| 39 | Momenta Investigational Site | Milano | Italy | 20133 | |
| 40 | Momenta Investigational Site | Krakow | Poland | 31-505 | |
| 41 | Momenta Investigational Site | Lodz | Poland | 90-324 | |
| 42 | Momenta Investigational Site | Warsaw | Poland | 01-684 | |
| 43 | Momenta Investigational Site | Warsaw | Poland | 01-868 | |
| 44 | Momenta Investigational Site | Barcelona | Catalan | Spain | 08035 |
| 45 | Momenta Investigational Site | Barcelona | Catalan | Spain | 08041 |
| 46 | Momenta Investigational Site | Barcelona | Cataluna | Spain | 08036 |
| 47 | Momenta Investigational Site | L'hospitalet De Llobregat | Cataluna | Spain | 08907 |
| 48 | Momenta Investigational Site | San Sebastian | Gipuzkoa | Spain | 20014 |
| 49 | Momenta Investigational Site | Madrid | Spain | 28007 | |
| 50 | Momenta Investigational Site | Madrid | Spain | 28040 | |
| 51 | Momenta Investigational Site | Sevilla | Spain | 41013 | |
| 52 | Momenta Investigational Site | Valencia | Spain | 46026 | |
| 53 | Momenta Investigational Site | Birmingham | United Kingdom | B15 2TH | |
| 54 | Momenta Investigational Site | Sheffield | United Kingdom | S11 9NE |
Sponsors and Collaborators
- Momenta Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03896295
Other Study ID Numbers:
- MOM-M281-005
- 2018-003618-41
First Posted:
Mar 29, 2019
Last Update Posted:
Feb 16, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Momenta Pharmaceuticals, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Participants from study MOM-M281-004 (NCT03772587) who completed the Day 113 visit of that study were eligible to enroll in this open-label extension study (MOM-M281-005). The Day 113 visit of MOM-M281-004 occurred approximately 8 weeks after the last dose in that study. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab |
|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W). | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Period Title: Overall Study | ||
| STARTED | 7 | 30 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 7 | 30 |
Baseline Characteristics
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Total |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W). | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Total of all reporting groups |
| Overall Participants | 7 | 30 | 37 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
5
71.4%
|
20
66.7%
|
25
67.6%
|
| >=65 years |
2
28.6%
|
10
33.3%
|
12
32.4%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53.7
(20.39)
|
53
(16.93)
|
53.2
(17.33)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
57.1%
|
18
60%
|
22
59.5%
|
| Male |
3
42.9%
|
12
40%
|
15
40.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
28.6%
|
2
6.7%
|
4
10.8%
|
| Not Hispanic or Latino |
5
71.4%
|
28
93.3%
|
33
89.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
3.3%
|
1
2.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| White |
5
71.4%
|
29
96.7%
|
34
91.9%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Other |
2
28.6%
|
0
0%
|
2
5.4%
|
| Region of Enrollment (Count of Participants) | |||
| GERMANY |
1
14.3%
|
1
3.3%
|
2
5.4%
|
| ITALY |
0
0%
|
2
6.7%
|
2
5.4%
|
| POLAND |
0
0%
|
7
23.3%
|
7
18.9%
|
| SPAIN |
4
57.1%
|
7
23.3%
|
11
29.7%
|
| UNITED STATES |
2
28.6%
|
13
43.3%
|
15
40.5%
|
Outcome Measures
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received intravenous (IV) infusion of nipocalimab 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W). | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 7 | 30 | 37 |
| Count of Participants [Participants] |
4
57.1%
|
18
60%
|
22
59.5%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 7 | 30 | 37 |
| Count of Participants [Participants] |
1
14.3%
|
4
13.3%
|
5
13.5%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 7 | 30 | 37 |
| Count of Participants [Participants] |
1
14.3%
|
1
3.3%
|
2
5.4%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 7 | 30 | 37 |
| Pulse rate: <=50 bpm with >=15 bpm decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
| Pulse rate: >= 120 bpm with >=15 bpm increase from baseline |
0
0%
|
0
0%
|
0
0%
|
| SBP: <= 90 mmHg with >= 20 mmHg decrease from baseline |
0
0%
|
1
3.3%
|
1
2.7%
|
| SBP: >= 160 mmHg with >= 20 mmHg increase from baseline |
0
0%
|
1
3.3%
|
1
2.7%
|
| DBP: <= 50 mmHg with >=15 mmHg decrease from baseline |
0
0%
|
2
6.7%
|
2
5.4%
|
| DBP: >=100 mmHg with >=15 mmHg decrease from baseline |
0
0%
|
0
0%
|
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 17 | 21 |
| Abdomen |
1
14.3%
|
0
0%
|
1
2.7%
|
| Head, Ears, Eyes, Nose, Throat and Sinuses |
0
0%
|
0
0%
|
0
0%
|
| Lungs |
0
0%
|
0
0%
|
0
0%
|
| Neurological |
0
0%
|
1
3.3%
|
1
2.7%
|
| Skin |
1
14.3%
|
4
13.3%
|
5
13.5%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 17 | 21 |
| Albumin |
-1.5
(2.89)
|
-1.2
(3.21)
|
-1.3
(3.08)
|
| Protein |
-3.5
(2.08)
|
-3.8
(4.99)
|
-3.7
(4.54)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 17 | 21 |
| Bicarbonate |
-2.0
(2.45)
|
1.6
(2.91)
|
1.0
(3.14)
|
| Calcium |
0.010
(0.0627)
|
-0.018
(0.1005)
|
-0.013
(0.0938)
|
| Chloride |
0.5
(1.91)
|
0.6
(2.85)
|
0.6
(2.66)
|
| Cholesterol |
0.480
(1.0100)
|
0.261
(0.5732)
|
0.303
(0.6509)
|
| Glucose |
0.280
(0.5054)
|
-0.258
(1.1401)
|
-0.155
(1.0607)
|
| Phosphate |
-0.018
(0.0971)
|
-0.002
(0.1903)
|
-0.005
(0.1744)
|
| Potassium |
0.05
(0.173)
|
0.05
(0.583)
|
0.05
(0.526)
|
| Sodium |
0.8
(0.96)
|
1.4
(2.18)
|
1.2
(2.00)
|
| Triglycerides |
0.223
(0.5799)
|
0.081
(0.3223)
|
0.108
(0.3699)
|
| Urate |
-0.0090
(0.04285)
|
0.0174
(0.04790)
|
0.124
(0.04716)
|
| Urea Nitrogen |
-0.270
(1.7830)
|
-0.105
(1.7292)
|
-0.136
(1.6951)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 17 | 21 |
| ALT |
17.0
(28.76)
|
2.6
(5.33)
|
5.3
(13.43)
|
| Alkaline Phosphatase |
6.3
(2.06)
|
5.2
(11.46)
|
5.4
(10.23)
|
| AST |
23.5
(47.67)
|
0.9
(3.42)
|
5.2
(20.80)
|
| Creatine Kinase |
-17.8
(33.13)
|
13.6
(38.34)
|
7.7
(38.73)
|
| Gamma Glutamyl Transferase |
4.3
(11.95)
|
1.5
(13.21)
|
2.0
(12.74)
|
| Lactate Dehydrogenase |
30.0
(15.68)
|
30.9
(58.10)
|
30.7
(52.00)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 17 | 21 |
| Bilirubin |
0.13
(2.616)
|
-0.59
(2.403)
|
-0.46
(2.393)
|
| Creatinine |
-9.0
(7.35)
|
-2.6
(13.20)
|
-3.9
(12.41)
|
| Direct Bilirubin |
-1.20
(NA)
|
-0.70
(0.283)
|
-0.87
(0.359)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 16 | 20 |
| Mean (Standard Deviation) [10^12 cells count per Liter] |
0.188
(0.0822)
|
0.121
(0.2702)
|
0.135
(0.2438)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 16 | 20 |
| Basophils |
-0.003
(0.0150)
|
0.010
(0.0200)
|
0.006
(0.0188)
|
| Eosinophils |
0.015
(0.0465)
|
0.013
(0.0776)
|
0.014
(0.0702)
|
| Lymphocytes |
-0.045
(0.4498)
|
0.063
(0.4715)
|
0.041
(0.4576)
|
| Monocytes |
-0.105
(0.1964)
|
0.059
(0.2008)
|
0.027
(0.2061)
|
| Neutrophils |
-0.433
(0.5744)
|
0.411
(1.8622)
|
0.243
(1.7058)
|
| Platelets |
27.8
(11.81)
|
12.3
(53.20)
|
15.4
(47.93)
|
| Leukocytes |
-0.568
(0.9214)
|
0.567
(1.9956)
|
0.340
(1.8694)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 16 | 20 |
| Mean (Standard Deviation) [grams per Liter (g/L)] |
-6.5
(25.70)
|
-2.1
(7.61)
|
-3.0
(12.38)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 16 | 20 |
| Mean (Standard Deviation) [picograms (pg)] |
0.03
(0.873)
|
-0.61
(0.813)
|
-0.48
(0.842)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 16 | 20 |
| Mean (Standard Deviation) [femtoliters (fL)] |
2.45
(6.174)
|
-1.41
(3.406)
|
-0.64
(4.206)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 16 | 20 |
| Mean (Standard Deviation) [liter of cells per liter of blood (L/L)] |
0.0278
(0.03542)
|
0.0048
(0.02401)
|
0.0094
(0.02725)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 16 | 20 |
| Mean (Standard Deviation) [g/L] |
5.8
(4.65)
|
0.6
(7.29)
|
1.7
(7.06)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 17 | 21 |
| Mean (Standard Deviation) [pH] |
-0.8
(0.96)
|
0.0
(1.06)
|
-0.1
(1.06)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 17 | 21 |
| Mean (Standard Deviation) [ratio] |
-0.0003
(0.00660)
|
-0.0030
(0.00973)
|
-0.0025
(0.00914)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg every Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 7 | 29 | 36 |
| ECG Mean Heart Rate (<= 50) |
0
0%
|
5
16.7%
|
5
13.5%
|
| ECG Mean Heart Rate (>=120) |
0
0%
|
0
0%
|
0
0%
|
| PR Interval (<120) |
0
0%
|
0
0%
|
0
0%
|
| PR Interval (> 200) |
0
0%
|
5
16.7%
|
5
13.5%
|
| RR Interval (<600) |
0
0%
|
0
0%
|
0
0%
|
| RR Interval (>=1200) |
0
0%
|
4
13.3%
|
4
10.8%
|
| QRS Duration (>120) |
1
14.3%
|
3
10%
|
4
10.8%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 6 | 30 | 36 |
| No Suicidal Ideation/Behavior |
5
71.4%
|
30
100%
|
35
94.6%
|
| Suicidal Ideation |
1
14.3%
|
0
0%
|
1
2.7%
|
| Suicidal Behavior |
0
0%
|
0
0%
|
0
0%
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set (FAS) 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 timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 5 | 26 | 31 |
| Week 4 |
0.6
(1.34)
|
-0.6
(2.42)
|
-0.4
(2.30)
|
| Week 8 |
-0.8
(3.70)
|
-0.9
(2.63)
|
-0.9
(2.80)
|
| Week 12 |
-0.3
(4.35)
|
-1.2
(2.49)
|
-1.0
(2.82)
|
| Week 24 |
-1.0
(NA)
|
-1.2
(1.92)
|
-1.2
(1.72)
|
| EoT (up to 253 days post-baseline) |
-2.4
(2.55)
|
-2.4
(2.55)
|
|
| Follow-up (up to 257 days post-baseline) |
-0.6
(1.14)
|
1.2
(3.08)
|
0.9
(2.91)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 7 | 30 | 37 |
| Week 4 (2 Point Improvement) |
2
28.6%
|
2
6.7%
|
|
| Week 4 (3 Point Improvement) |
1
14.3%
|
1
3.3%
|
|
| Week 4 (4 Point Improvement) |
0
0%
|
0
0%
|
|
| Week 4 (5 Point Improvement) |
1
14.3%
|
1
3.3%
|
|
| Week 4 (6 Point Improvement) |
2
28.6%
|
2
6.7%
|
|
| Week 4 (7 Point Improvement) |
0
0%
|
0
0%
|
|
| Week 4 (>= 8 Point Improvement) |
0
0%
|
0
0%
|
|
| Week 8 (2 Point Improvement) |
1
14.3%
|
2
6.7%
|
3
8.1%
|
| Week 8 (3 Point Improvement) |
0
0%
|
4
13.3%
|
4
10.8%
|
| Week 8 (4 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (5 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (6 Point Improvement) |
1
14.3%
|
0
0%
|
1
2.7%
|
| Week 8 (7 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (>= 8 Point Improvement) |
0
0%
|
1
3.3%
|
1
2.7%
|
| Week 12 (2 Point Improvement) |
0
0%
|
2
6.7%
|
2
5.4%
|
| Week 12 (3 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Week 12 (4 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Week 12 (5 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Week 12 (6 Point Improvement) |
1
14.3%
|
3
10%
|
4
10.8%
|
| Week 12 (7 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Week 12 (>= 8 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Week 24 (2 Point Improvement) |
1
14.3%
|
1
3.3%
|
|
| Week 24 (3 Point Improvement) |
0
0%
|
0
0%
|
|
| Week 24 (4 Point Improvement) |
1
14.3%
|
1
3.3%
|
|
| Week 24 (5 Point Improvement) |
0
0%
|
0
0%
|
|
| Week 24 (6 Point Improvement) |
0
0%
|
0
0%
|
|
| Week 24 (7 Point Improvement) |
0
0%
|
0
0%
|
|
| Week 24 (>= 8 Point Improvement) |
0
0%
|
0
0%
|
|
| EoT (up to 253 days post-baseline) (2 Point Improvement) |
2
28.6%
|
2
6.7%
|
|
| EoT (up to 253 days post-baseline) (3 Point Improvement) |
2
28.6%
|
2
6.7%
|
|
| EoT (up to 253 days post-baseline) (4 Point Improvement) |
0
0%
|
0
0%
|
|
| EoT (up to 253 days post-baseline) (5 Point Improvement) |
1
14.3%
|
1
3.3%
|
|
| EoT (up to 253 days post-baseline) (6 Point Improvement) |
1
14.3%
|
1
3.3%
|
|
| EoT (up to 253 days post-baseline) (7 Point Improvement) |
2
28.6%
|
2
6.7%
|
|
| EoT (up to 253 days post-baseline) (>= 8 Point Improvement) |
0
0%
|
0
0%
|
|
| Follow-up (up to 257 days post-baseline) (2 Point Improvement) |
1
14.3%
|
3
10%
|
4
10.8%
|
| Follow-up (up to 257 days post-baseline) (3 Point Improvement) |
0
0%
|
1
3.3%
|
1
2.7%
|
| Follow-up (up to 257 days post-baseline) (4 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Follow-up (up to 257 days post-baseline) (5 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Follow-up (up to 257 days post-baseline) (6 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Follow-up (up to 257 days post-baseline) (7 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| Follow-up (up to 257 days post-baseline) (>= 8 Point Improvement) |
0
0%
|
0
0%
|
0
0%
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS 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 timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 2 | 9 | 11 |
| Week 4 |
1.5
(6.36)
|
-1.3
(2.60)
|
-0.8
(3.28)
|
| Week 8 |
-3.0
(5.66)
|
1.0
(1.53)
|
0.1
(2.98)
|
| Week 12 |
-0.5
(3.54)
|
-1.2
(2.23)
|
-1.0
(2.33)
|
| Week 24 |
-2.7
(1.53)
|
-2.7
(1.53)
|
|
| EoT (up to 253 days post-baseline) |
-2.4
(4.12)
|
-2.4
(4.12)
|
|
| Follow-up (up to 257 days post-baseline) |
-3.0
(NA)
|
-1.6
(2.07)
|
-1.8
(1.98)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS included all participants who received at least 1 dose of study drug nipocalimab. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 7 | 30 | 37 |
| Week 4 |
1.4
(3.85)
|
-2.2
(4.53)
|
-1.6
(4.57)
|
| Week 8 |
-0.4
(3.97)
|
-1.9
(4.34)
|
-1.6
(4.23)
|
| Week 12 |
-1.0
(6.27)
|
-3.4
(4.70)
|
-2.9
(4.95)
|
| Week 24 |
-3.0
(NA)
|
-1.4
(1.52)
|
-1.7
(1.51)
|
| EoT (up to 253 days post-baseline) |
-3.7
(5.28)
|
-3.7
(5.28)
|
|
| Follow-up (up to 257 days post-baseline) |
-1.3
(5.72)
|
0.1
(3.11)
|
-0.2
(3.69)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS 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 timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 5 | 26 | 31 |
| Week 4 |
-0.2
(0.84)
|
-0.3
(0.60)
|
-0.3
(0.63)
|
| Week 8 |
-1.0
(0.71)
|
-0.6
(0.90)
|
-0.7
(0.86)
|
| Week 12 |
-0.5
(1.00)
|
-0.5
(0.80)
|
-0.5
(0.81)
|
| Week 24 |
0.0
(NA)
|
-0.6
(0.89)
|
-0.5
(0.84)
|
| EoT (up to 253 days post-baseline) |
-0.7
(0.95)
|
-0.7
(0.95)
|
|
| Follow-up (up to 257 days post-baseline) |
-1.0
(1.22)
|
-0.1
(0.73)
|
-0.3
(0.88)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS 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 timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 5 | 26 | 31 |
| Week 4 (Very much worse) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (Much worse) |
0
0%
|
0
0%
|
0
0%
|
| Week 4 (Minimally worse) |
1
14.3%
|
2
6.7%
|
3
8.1%
|
| Week 4 (No change) |
1
14.3%
|
7
23.3%
|
8
21.6%
|
| Week 4 (Minimally improved) |
2
28.6%
|
12
40%
|
14
37.8%
|
| Week 4 (Much improved) |
0
0%
|
5
16.7%
|
5
13.5%
|
| Week 4 (Very much improved) |
1
14.3%
|
0
0%
|
1
2.7%
|
| Week 8 (Very much worse) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (Much worse) |
0
0%
|
0
0%
|
0
0%
|
| Week 8 (Minimally worse) |
0
0%
|
2
6.7%
|
2
5.4%
|
| Week 8 (No change) |
0
0%
|
3
10%
|
3
8.1%
|
| Week 8 (Minimally improved) |
2
28.6%
|
6
20%
|
8
21.6%
|
| Week 8 (Much improved) |
2
28.6%
|
8
26.7%
|
10
27%
|
| Week 8 (Very much improved) |
1
14.3%
|
0
0%
|
1
2.7%
|
| Week 12 (Very much worse) |
0
0%
|
0
0%
|
0
0%
|
| Week 12 (Much worse) |
0
0%
|
0
0%
|
0
0%
|
| Week 12 (Minimally worse) |
0
0%
|
2
6.7%
|
2
5.4%
|
| Week 12 (No change) |
2
28.6%
|
1
3.3%
|
3
8.1%
|
| Week 12 (Minimally improved) |
1
14.3%
|
3
10%
|
4
10.8%
|
| Week 12 (Much improved) |
1
14.3%
|
10
33.3%
|
11
29.7%
|
| Week 12 (Very much improved) |
0
0%
|
1
3.3%
|
1
2.7%
|
| Week 24 (Very Much worse) |
0
0%
|
0
0%
|
0
0%
|
| Week 24 (Much worse) |
0
0%
|
0
0%
|
0
0%
|
| Week 24 (Minimally worse) |
0
0%
|
0
0%
|
0
0%
|
| Week 24 (No change) |
1
14.3%
|
0
0%
|
1
2.7%
|
| Week 24 (Minimally improved) |
0
0%
|
1
3.3%
|
1
2.7%
|
| Week 24 (Much improved) |
0
0%
|
4
13.3%
|
4
10.8%
|
| Week 24 (Very Much improved) |
0
0%
|
0
0%
|
0
0%
|
| EoT (up to 253 days post-baseline)(Very Much worse) |
0
0%
|
0
0%
|
|
| EoT (up to 253 days post-baseline)(Much worse) |
0
0%
|
0
0%
|
|
| EoT (up to 253 days post-baseline) (Minimally worse) |
0
0%
|
0
0%
|
|
| EoT (up to 253 days post-baseline) (No change) |
1
14.3%
|
1
3.3%
|
|
| EoT (up to 253 days post-baseline)(Minimally improved) |
7
100%
|
7
23.3%
|
|
| EoT (up to 253 days post-baseline)(Much improved) |
7
100%
|
7
23.3%
|
|
| EoT (up to 253 days post-baseline)(Very much improved) |
1
14.3%
|
1
3.3%
|
|
| Follow-up (up to 257 days post-baseline) (Very Much worse) |
0
0%
|
0
0%
|
0
0%
|
| Follow-up (up to 257 days post-baseline) (Much worse) |
1
14.3%
|
2
6.7%
|
3
8.1%
|
| Follow-up (up to 257 days post-baseline) (Minimally worse) |
0
0%
|
3
10%
|
3
8.1%
|
| Follow-up (up to 257 days post-baseline) (No change) |
0
0%
|
5
16.7%
|
5
13.5%
|
| Follow-up (up to 257 days post-baseline) (Minimally improved) |
0
0%
|
8
26.7%
|
8
21.6%
|
| Follow-up (up to 257 days post-baseline) (Much improved) |
3
42.9%
|
2
6.7%
|
5
13.5%
|
| Follow-up (up to 257 days post-baseline) (Very much improved) |
1
14.3%
|
1
3.3%
|
2
5.4%
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS 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 timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 4 | 9 | 13 |
| Week 8 (Improved) |
1
14.3%
|
5
16.7%
|
6
16.2%
|
| Week 8 (Same) |
3
42.9%
|
3
10%
|
6
16.2%
|
| Week 8 (Worsened) |
0
0%
|
1
3.3%
|
1
2.7%
|
| Week 24 (Improved) |
0
0%
|
0
0%
|
0
0%
|
| Week 24 (Same) |
1
14.3%
|
1
3.3%
|
2
5.4%
|
| Week 24 (Worsened) |
0
0%
|
0
0%
|
0
0%
|
| EoT (up to 253 days post-baseline)(Improved) |
4
57.1%
|
4
13.3%
|
|
| EoT (up to 253 days post-baseline)(Same) |
3
42.9%
|
3
10%
|
|
| EoT (up to 253 days post-baseline)(Worsened) |
1
14.3%
|
1
3.3%
|
| Title | Number of Participants With Anti-drug Antibodies (ADA) to Nipocalimab |
|---|---|
| Description | Number of participants with ADA to nipocalimab were reported. |
| Time Frame | Up to 257 days post-baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 6 | 29 | 35 |
| Count of Participants [Participants] |
0
0%
|
3
10%
|
3
8.1%
|
| Title | Number of Participants With Neutralizing Antibodies (NAbs) to Nipocalimab |
|---|---|
| Description | Number of participants with NAbs were reported. Samples positive for ADA in this study could not be further analyzed for neutralizing antibodies (NAbs) to nipocalimab due to limited number of participants developed ADA. |
| Time Frame | Up to 257 days post-baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS included all participants who received at least 1 dose of study drug nipocalimab. Per planned analysis, both individual arms and an arm for all (total) participants is presented. Data was not collected for NAbs because only 3 participants in this study had ADA titers. When comparing peak titers in this study with those in MOM-M281-004 (NCT03772587) study, only 1 participant newly developed ADA titers with peak titer of 1:7,680 in this study. Due to this low incidence, NAb was not measured. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 0 | 0 | 0 |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 7 | 28 | 35 |
| APTT (>ULN) |
2
28.6%
|
15
50%
|
17
45.9%
|
| APTT (<LLN) |
0
0%
|
3
10%
|
3
8.1%
|
| PT (>ULN) |
1
14.3%
|
8
26.7%
|
9
24.3%
|
| PT (<ULN) |
0
0%
|
1
3.3%
|
1
2.7%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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' included the number of participants evaluated for specific timepoints. As per planned analysis, data is reported for individual arms and for all (total) participants both. |
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | Nipocalimab (All Participants) |
|---|---|---|---|
| Arm/Group Description | Participants who received placebo in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | All participants who received placebo or nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. |
| Measure Participants | 5 | 27 | 32 |
| Week 2 |
-6.888
(0.6104)
|
-5.457
(1.2510)
|
-5.681
(1.2804)
|
| Week 4 |
-3.234
(1.1858)
|
-2.796
(0.9728)
|
-2.866
(1.0014)
|
| Week 8 |
-2.996
(1.3773)
|
-3.122
(1.3466)
|
-3.095
(1.3235)
|
| Week 12 |
-3.243
(1.6378)
|
-3.639
(2.2627)
|
-3.563
(2.1269)
|
| Week 24 |
-3.870
(NA)
|
-4.072
(1.2826)
|
-4.038
(1.1502)
|
| 253 days post-baseline |
-3.494
(1.9208)
|
-3.494
(1.9208)
|
|
| 257 days post-baseline |
-1.150
(0.5687)
|
-0.020
(1.6162)
|
-0.289
(1.5056)
|
Adverse Events
| Time Frame | Up to 257 days post-baseline (Day 1) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The safety analysis set included all participants who received at least 1 dose of study drug nipocalimab. | |||
| Arm/Group Title | Placebo-Nipocalimab | Nipocalimab-Nipocalimab | ||
| Arm/Group Description | Participants who received placebo in MOM-M281-004 (NCT03772587) study rolled-over and received intravenous (IV) infusion of nipocalimab (M281) 30 milligrams per kilogram (mg/kg) every 4 weeks (Q4W) starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding every 2 weeks (Q2W). | Participants who received nipocalimab in MOM-M281-004 study rolled-over and received IV infusion of nipocalimab 30 mg/kg Q4W starting Day 1 up to 8 weeks. After 8 weeks of treatment on a stable dose of nipocalimab, the dose and/or dosing frequency could be individually adjusted, at the investigator's discretion to receive maximum dose of 60 mg/kg at a frequency of not exceeding Q2W. | ||
All Cause Mortality |
||||
| Placebo-Nipocalimab | Nipocalimab-Nipocalimab | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/7 (0%) | 1/30 (3.3%) | ||
Serious Adverse Events |
||||
| Placebo-Nipocalimab | Nipocalimab-Nipocalimab | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/7 (14.3%) | 4/30 (13.3%) | ||
| Infections and infestations | ||||
| Coronavirus Infection | 0/7 (0%) | 1/30 (3.3%) | ||
| Covid-19 Pneumonia | 1/7 (14.3%) | 0/30 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Gliosarcoma | 0/7 (0%) | 1/30 (3.3%) | ||
| Nervous system disorders | ||||
| Myasthenia Gravis | 0/7 (0%) | 2/30 (6.7%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo-Nipocalimab | Nipocalimab-Nipocalimab | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/7 (57.1%) | 17/30 (56.7%) | ||
| Blood and lymphatic system disorders | ||||
| Iron Deficiency Anaemia | 0/7 (0%) | 1/30 (3.3%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo Positional | 1/7 (14.3%) | 0/30 (0%) | ||
| Eye disorders | ||||
| Conjunctival Haemorrhage | 0/7 (0%) | 1/30 (3.3%) | ||
| Conjunctival Hyperaemia | 0/7 (0%) | 1/30 (3.3%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 0/7 (0%) | 2/30 (6.7%) | ||
| Dyspepsia | 0/7 (0%) | 1/30 (3.3%) | ||
| Nausea | 0/7 (0%) | 2/30 (6.7%) | ||
| Toothache | 1/7 (14.3%) | 0/30 (0%) | ||
| Vomiting | 0/7 (0%) | 1/30 (3.3%) | ||
| General disorders | ||||
| Asthenia | 0/7 (0%) | 1/30 (3.3%) | ||
| Feeling Hot | 0/7 (0%) | 1/30 (3.3%) | ||
| Oedema Peripheral | 1/7 (14.3%) | 3/30 (10%) | ||
| Peripheral Swelling | 0/7 (0%) | 1/30 (3.3%) | ||
| Pyrexia | 0/7 (0%) | 1/30 (3.3%) | ||
| Infections and infestations | ||||
| Herpes Zoster | 0/7 (0%) | 1/30 (3.3%) | ||
| Nasopharyngitis | 0/7 (0%) | 1/30 (3.3%) | ||
| Oral Herpes | 0/7 (0%) | 1/30 (3.3%) | ||
| Otitis Media | 0/7 (0%) | 1/30 (3.3%) | ||
| Pharyngitis | 0/7 (0%) | 1/30 (3.3%) | ||
| Sinusitis | 0/7 (0%) | 1/30 (3.3%) | ||
| Upper Respiratory Tract Infection | 0/7 (0%) | 2/30 (6.7%) | ||
| Viral Upper Respiratory Tract Infection | 0/7 (0%) | 1/30 (3.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 0/7 (0%) | 1/30 (3.3%) | ||
| Foot Fracture | 0/7 (0%) | 1/30 (3.3%) | ||
| Foreign Body | 0/7 (0%) | 1/30 (3.3%) | ||
| Ligament Sprain | 0/7 (0%) | 1/30 (3.3%) | ||
| Skin Laceration | 0/7 (0%) | 1/30 (3.3%) | ||
| Wound | 0/7 (0%) | 1/30 (3.3%) | ||
| Investigations | ||||
| Blood Creatine Phosphokinase Increased | 0/7 (0%) | 1/30 (3.3%) | ||
| Blood Immunoglobulin G Decreased | 1/7 (14.3%) | 4/30 (13.3%) | ||
| Blood Potassium Decreased | 0/7 (0%) | 1/30 (3.3%) | ||
| Hepatic Enzyme Increased | 1/7 (14.3%) | 0/30 (0%) | ||
| Lymphocyte Count Decreased | 0/7 (0%) | 2/30 (6.7%) | ||
| Neutrophil Count Increased | 0/7 (0%) | 2/30 (6.7%) | ||
| Platelet Count Decreased | 0/7 (0%) | 1/30 (3.3%) | ||
| White Blood Cell Count Increased | 0/7 (0%) | 1/30 (3.3%) | ||
| Metabolism and nutrition disorders | ||||
| Vitamin B6 Deficiency | 0/7 (0%) | 1/30 (3.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/7 (14.3%) | 1/30 (3.3%) | ||
| Osteoporosis | 0/7 (0%) | 1/30 (3.3%) | ||
| Pain in Extremity | 0/7 (0%) | 1/30 (3.3%) | ||
| Nervous system disorders | ||||
| Headache | 0/7 (0%) | 2/30 (6.7%) | ||
| Myasthenia Gravis | 1/7 (14.3%) | 0/30 (0%) | ||
| Neuropathy Peripheral | 0/7 (0%) | 1/30 (3.3%) | ||
| Paraesthesia | 0/7 (0%) | 1/30 (3.3%) | ||
| Psychiatric disorders | ||||
| Depressed Mood | 1/7 (14.3%) | 0/30 (0%) | ||
| Reproductive system and breast disorders | ||||
| Adenomyosis | 0/7 (0%) | 1/30 (3.3%) | ||
| Menorrhagia | 0/7 (0%) | 1/30 (3.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Aphonia | 0/7 (0%) | 1/30 (3.3%) | ||
| Cough | 0/7 (0%) | 1/30 (3.3%) | ||
| Dyspnoea | 0/7 (0%) | 1/30 (3.3%) | ||
| Increased Viscosity of Upper Respiratory Secretion | 0/7 (0%) | 1/30 (3.3%) | ||
| Oropharyngeal Pain | 0/7 (0%) | 1/30 (3.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash Maculo-Papular | 1/7 (14.3%) | 0/30 (0%) | ||
Limitations/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.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
| Name/Title | DIRECTOR CLINICAL RESEARCH |
|---|---|
| Organization | Momenta Pharmaceuticals, Inc. |
| Phone | 844-434-4210 |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03896295
Other Study ID Numbers:
- MOM-M281-005
- 2018-003618-41
First Posted:
Mar 29, 2019
Last Update Posted:
Feb 16, 2022
Last Verified:
Jan 1, 2022