Myasthenia Gravis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.
Interventions
DRUGNipocalimab
Nipocalimab will be administered as an IV infusion.
DRUGPlacebo
Matching placebo will be administered as an IV infusion.
DRUGNipocalimab SC-LIV
Nipocalimab will be administered subcutaneously.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening * Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 6 at screening and baseline * Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol * A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention * A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention * For the SC Substudy (Cohort 1 and Cohort 2): Has reasonable abdominal skin area for SC administration * For the SC Substudy (Cohort 1 and Cohort 2): Participants must be willing to comply with maintaining their stable dose of corticosteroids and/or immunosuppressants for the initial 8 weeks of the SC substudy, that is, through the SC Week 8 visit
Exclusion criteria
* Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant * Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG) * Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study * Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients * Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening * For the SC Substudy (Cohort 1): Participants who have undergone a recent tapering of their concomitant MG medication in the OLE * For the SC Substudy (Cohort 1): Participants deteriorating during the OLE in the month prior to SC Dose 1 of the SC substudy such that they meet the criteria for clinical deterioration * For the SC Substudy (Cohort 2): History of an unprovoked pulmonary embolism within 1 year prior to screening or history of recurrent deep vein thrombosis (DVT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | Baseline, Weeks 22, 23, and 24 | Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of 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, eyelid droop) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores. |
| Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) | — |
| Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) | — |
Secondary
| Measure | Time frame |
|---|---|
| Sub Study: Number of Participants With Injection Site-Reactions | Up to SC Week 8 (Day 57) |
| Sub Study: Change From Baseline in MG-ADL Clinician-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in QMG Clinician-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| DB Phase: Average Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24 | Baseline, Weeks 22, and 24 |
| DB Phase: Percentage of Participants Who Had Achieved at Least a 2-point Average Improvement From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | Weeks 22, 23, and 24 |
| DB Phase: Percentage of Participants Who Had Achieved an Improvement of Greater Than or Equal to (>=) 2 Points in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score at Week 1 and/or Week 2 | Weeks 1 and 2 |
| DB Phase: Percentage of Participants Who Had an Improvement of >= 2 Points in the MG-ADL Total Score From Week 4 Through Week 24 With no More Than 2 Non-consecutive Excursions Allowed Between Weeks 6 Through 23 | From Week 4 up to Week 24 |
| DB Phase: Percentage of Participants Who Had Achieved at Least a 50 Percent (%) Average Improvement From Baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | Weeks 22, 23, and 24 |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Percentage of Participants With AEs of Special Interest (AESIs) | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Number of Participants With Change in Vital Signs | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Number of Participants With Change in Clinical Laboratory Values | From start of treatment (DB phase Day 1) up to 4 years 9 months |
| Number of Participants With Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score | From start of treatment (Day 1) up to 4 years 9 months |
| DB Phase: Percentage of Participants Who Had an Improvement of >= 3 Points in Quantitative Myasthenia Gravis (QMG) Score From Baseline, at Week 2 Through Week 24, With No More Than 2 Non-consecutive Excursions Allowed Between at Weeks 4 Through Week 22 | Baseline, Week 2 up to Week 24 |
| DB Phase: Average Change From Baseline in the Fatigue Items of the Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Scale Total Score Over Weeks 22 and 24 | Baseline up to Weeks 22, and 24 |
| DB Phase: Average Change From Baseline in the Revised Myasthenia Gravis Quality of Life (Revised) Instrument (MG-Qol15r) Score Over Weeks 22 And 24 | Baseline up to Weeks 22, and 24 |
| DB Phase: Change From Baseline in the Visual Analog Scale (VAS) Score of European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks | Baseline up to Week 24 |
| DB Phase: Change From Baseline in the Health Status Index of the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks | Baseline up to Week 24 |
| DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 Over Time | Baseline up to Week 24 |
| DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at Any Time | Baseline up to Week 24 |
| DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 50% of Timepoints | Baseline up to Week 24 |
| DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 75% of Timepoints | Baseline up to Week 24 |
| Serum Concentrations of Nipocalimab Over Time | DB Phase: Predose and 45 minutes post-dose on Day 1, Weeks 2, 4, 8, 12,16, 20, 24;OL Phase: Predose on Day 1, Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96 |
| Number of Participants With Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs]) | From start of treatment (Day 1) up to 4 years 9 months |
| Percent Change From Baseline in Total Serum Immunoglobulin G (IgG) Concentrations | Baseline up to 4 years 9 months |
| Change From Baseline in Levels of Autoantibodies Associated With Generalized Myasthenia Gravis (gMG) | Baseline up to 4 years 9 months |
| Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Function of IgG | Baseline up to 4 years 9 months |
| Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score as a Function of Immunoglobulin G (IgG) | Baseline up to 4 years 9 months |
| Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab | Baseline up to 4 years 9 months |
| Change From Baseline in QMG Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab | Baseline up to 4 years 9 months |
| Sub Study: Number of Participants With Treatment-Emergent AEs | Up to SC Week 8 (Day 57) |
| Sub Study: Number of Participants With Abnormalities in Vital Signs | Up to SC Week 8 (Day 57) |
| Sub Study: Change From Baseline in Myasthenia Gravis Foundation of America (MGFA) Clinician-Reported Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in C-SSRS Clinician-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in Neuro-QoL Participant-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in Patient Global Impression of Severity (PGIS) Scale Score up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in Patient Global Impression of Change (PGIC) Scale Score up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in MG-QoL Participant-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Change From Baseline in EQ-5D-5L Participant-Reported Outcome Measures up to Week 8 (Day 57) | From baseline (pre-first nipocalimab dose on Day 1) up to Week 8 (Day 57) |
| Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) |
| Sub Study: Number of Participants With Abnormalities in Physical Examinations | Up to SC Week 8 (Day 57) |
| Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57) | From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57) |
| Sub Study: Number of Participants With Abnormalities in Laboratory Parameters | Up to SC Week 8 (Day 57) |
| Sub Study: Numeric Pain Rating Scale (NPRS) Assessment With SC Use of Nipocalimab | Up to SC Week 8 (Day 57) |
Countries
Australia, Belgium, Canada, China, Czechia, Denmark, France, Germany, Italy, Japan, Mexico, Poland, South Korea, Spain, Sweden, Taiwan, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Participant flow
Pre-assignment details
As per protocol amendment 4, sub-study was added for which recruitment is currently ongoing. The current result are reported up to the (PCD, 17-Nov-2023) of double blind phase. For open-label extension (OLE) phase, data for participants that were enrolled in OLE phase until the PCD is presented. OLE phase is still ongoing and complete results will be posted upon study completion.
Participants by arm
| Arm | Count |
|---|---|
| Double Blind (DB) Phase: Placebo During double blind (DB) phase, participants of present study received placebo matching to nipocalimab intravenous (IV) infusion as a loading dose on Day 1 (Week 0) followed by placebo matching to nipocalimab IV infusion as maintenance dose once every 2 weeks (q2w) from Week 2 up to Week 24. | 98 |
| DB Phase: Nipocalimab During DB phase, participants of present study received nipocalimab 30 milligrams per kilogram (mg/kg) IV infusion as a loading dose on Day 1 (Week 0) followed by nipocalimab 15 mg/kg IV infusion as maintenance dose once q2w from Week 2 up to Week 24. | 98 |
| OLE Phase: Nipocalimab (MOM-M281-004 and MOM-M281-005) Participants who received nipocalimab in studies MOM-M281-004 (NCT03772587) and MOM-M281-005 (NCT03896295) entered OLE phase of the present study and received nipocalimab 15 mg/kg IV infusion q2w from OLE phase Day 1. | 19 |
| Total | 215 |
Baseline characteristics
| Characteristic | Double Blind (DB) Phase: Placebo | DB Phase: Nipocalimab | OLE Phase: Nipocalimab (MOM-M281-004 and MOM-M281-005) | Total |
|---|---|---|---|---|
| Age, Continuous | 52.7 Years STANDARD_DEVIATION 15.6 | 52.9 Years STANDARD_DEVIATION 15.49 | 52.7 Years STANDARD_DEVIATION 17.69 | 52.8 Years STANDARD_DEVIATION 15.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 5 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants | 87 Participants | 14 Participants | 190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 29 Participants | 28 Participants | 0 Participants | 57 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 65 Participants | 66 Participants | 19 Participants | 150 Participants |
| Sex: Female, Male Female | 56 Participants | 66 Participants | 10 Participants | 132 Participants |
| Sex: Female, Male Male | 42 Participants | 32 Participants | 9 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 99 | 1 / 100 | 1 / 88 | 1 / 88 | 1 / 19 |
| other Total, other adverse events | 65 / 98 | 69 / 98 | 57 / 88 | 59 / 88 | 18 / 19 |
| serious Total, serious adverse events | 14 / 98 | 9 / 98 | 10 / 88 | 16 / 88 | 7 / 19 |
Outcome results
Primary
Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24
Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of 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, eyelid droop) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores.
Time frame: Baseline, Weeks 22, 23, and 24
Population: Primary efficacy analysis set included all randomized seropositive (with anti- acetylcholine receptor positive, anti muscle-specific kinase positive, and/or anti- lipoprotein-related protein receptor 4 positive) participants who received at least 1 dose (partial or complete) of any study intervention in the double-blind phase. Here, 'N' (overall number of participants analysed) signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double Blind (DB) Phase: Placebo | Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | -3.25 Score on a scale | Standard Error 0.335 |
| DB Phase: Nipocalimab | Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24 | -4.70 Score on a scale | Standard Error 0.329 |
p-value: =0.00295% CI: [-2.38, -0.52]mixed effects model for repeated measure
Secondary
Change From Baseline in Levels of Autoantibodies Associated With Generalized Myasthenia Gravis (gMG)
Time frame: Baseline up to 4 years 9 months
Secondary
Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Function of IgG
Time frame: Baseline up to 4 years 9 months
Secondary
Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab
Time frame: Baseline up to 4 years 9 months
Secondary
Change From Baseline in QMG Score as a Response to Percent Change in Autoantibody Levels in Seropositive Participants Treated With Nipocalimab
Time frame: Baseline up to 4 years 9 months
Secondary
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score as a Function of Immunoglobulin G (IgG)
Time frame: Baseline up to 4 years 9 months
Secondary
DB Phase: Average Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score Over Weeks 22 and 24
Time frame: Baseline, Weeks 22, and 24
Secondary
DB Phase: Average Change From Baseline in the Fatigue Items of the Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Scale Total Score Over Weeks 22 and 24
Time frame: Baseline up to Weeks 22, and 24
Secondary
DB Phase: Average Change From Baseline in the Revised Myasthenia Gravis Quality of Life (Revised) Instrument (MG-Qol15r) Score Over Weeks 22 And 24
Time frame: Baseline up to Weeks 22, and 24
Secondary
DB Phase: Change From Baseline in the Health Status Index of the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks
Time frame: Baseline up to Week 24
Secondary
DB Phase: Change From Baseline in the Visual Analog Scale (VAS) Score of European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ-5D-5L) Scale Over 24 Weeks
Time frame: Baseline up to Week 24
Secondary
DB Phase: Percentage of Participants Who Had Achieved an Improvement of Greater Than or Equal to (>=) 2 Points in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score at Week 1 and/or Week 2
Time frame: Weeks 1 and 2
Secondary
DB Phase: Percentage of Participants Who Had Achieved at Least a 2-point Average Improvement From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24
Time frame: Weeks 22, 23, and 24
Secondary
DB Phase: Percentage of Participants Who Had Achieved at Least a 50 Percent (%) Average Improvement From Baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24
Time frame: Weeks 22, 23, and 24
Secondary
DB Phase: Percentage of Participants Who Had an Improvement of >= 2 Points in the MG-ADL Total Score From Week 4 Through Week 24 With no More Than 2 Non-consecutive Excursions Allowed Between Weeks 6 Through 23
Time frame: From Week 4 up to Week 24
Secondary
DB Phase: Percentage of Participants Who Had an Improvement of >= 3 Points in Quantitative Myasthenia Gravis (QMG) Score From Baseline, at Week 2 Through Week 24, With No More Than 2 Non-consecutive Excursions Allowed Between at Weeks 4 Through Week 22
Time frame: Baseline, Week 2 up to Week 24
Secondary
DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 50% of Timepoints
Time frame: Baseline up to Week 24
Secondary
DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at 75% of Timepoints
Time frame: Baseline up to Week 24
Secondary
DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 at Any Time
Time frame: Baseline up to Week 24
Secondary
DB Phase: Percentage of Participants With Myasthenia Gravis - Activities of Daily Living (MG-ADL) Score of 0 or 1 Over Time
Time frame: Baseline up to Week 24
Secondary
Number of Participants With Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [NAbs])
Time frame: From start of treatment (Day 1) up to 4 years 9 months
Secondary
Number of Participants With Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame: From start of treatment (Day 1) up to 4 years 9 months
Secondary
Number of Participants With Change in Clinical Laboratory Values
Time frame: From start of treatment (DB phase Day 1) up to 4 years 9 months
Secondary
Number of Participants With Change in Vital Signs
Time frame: From start of treatment (DB phase Day 1) up to 4 years 9 months
Secondary
Percentage of Participants With AEs of Special Interest (AESIs)
Time frame: From start of treatment (DB phase Day 1) up to 4 years 9 months
Secondary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From start of treatment (DB phase Day 1) up to 4 years 9 months
Secondary
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From start of treatment (DB phase Day 1) up to 4 years 9 months
Secondary
Percent Change From Baseline in Total Serum Immunoglobulin G (IgG) Concentrations
Time frame: Baseline up to 4 years 9 months
Secondary
Serum Concentrations of Nipocalimab Over Time
Time frame: DB Phase: Predose and 45 minutes post-dose on Day 1, Weeks 2, 4, 8, 12,16, 20, 24;OL Phase: Predose on Day 1, Weeks 8, 16, 24, 36, 48, 60, 72, 84, and 96