| Secondary | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score at Week 26 in the Overall Study Population | The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease. Outcome measure is reported for the overall population. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-2.3(-3.4 to -1.3)
- OG001-4.8(-5.8 to -3.8)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mixed-effects model for repeated measure | | 0.0002 | Based on difference in mean change. Covariates of treatment group, baseline antibody status and steroid use, baseline QMG and MG-ADL, visits, interaction between visit and treatment group. | Difference in mean change | -2.5 | | | 2-Sided | 95 | -3.8 | -1.2 | | | | | Superiority | Significance level (2-sided) of 0.05 | |
|
| Secondary | Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab+: Placebo | |
|
| Secondary | Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab+: Placebo | Anti-MuSK-Ab+ participants received placebo IV on Day 1 and Day 15 in the RCP. |
|
| Secondary | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in the Overall Study Population | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. The protocol-allowed rescue therapy options included intravenous immunoglobulin (IVIg) and therapeutic plasma exchange (PLEX). Outcome measure is reported for the overall population. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Count of Participants | | Participants | | Up to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
|
| Secondary | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. The protocol-allowed rescue therapy options included IVIg and PLEX. Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Count of Participants | | Participants | | Up to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 |
|
| Secondary | Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 52 and no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. The protocol-allowed rescue therapy options included IVIg and PLEX. Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Up to Week 52 | | Participants | | | | |
| Secondary | Percentage of Participants With no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population | The protocol-allowed rescue therapy options included corticosteroids, IVIg and PLEX. Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Up to Week 52 | | Participants | | | | |
| Secondary | Change From Baseline in MG-ADL Score at Week 52 in the Anti-AChR-Ab+ Population | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Baseline and Week 52 | | Participants | | | | |
| Secondary | Change From Baseline in QMG Score at Week 52 in the Anti-AChR-Ab+ Population | The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease. Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Baseline and Week 52 | | Participants | | | | |
| Secondary | Change From Baseline in Myasthenia Gravis Composite (MGC) Score at Week 26 in the Overall Study Population | The MGC score consists of test items from MG-ADL score and the QMG score, with weighted response options. Scores range from 0-50, with higher scores indicating worse disease manifestations. Outcome measure is reported for the overall population. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
| |
| Secondary | Change From Baseline in MGC Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | The MGC score consists of test items from MG-ADL score and the QMG score, with weighted response options. Scores range from 0-50, with higher scores indicating worse disease manifestations. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab+: Placebo | Anti-MuSK-Ab+ participants received placebo IV on Day 1 and Day 15 in the RCP. | | OG003 | Anti-MuSK-Ab+: Inebilizumab 300 mg |
|
| Secondary | Change From Baseline in MGC Score at Week 52 in Anti-AChR-Ab+ Population | The MGC score consists of test items from MG-ADL score and the QMG score, with weighted response options. Scores range from 0-50, with higher scores indicating worse disease manifestations. Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Baseline and Week 52 | | Participants | | | | |
| Primary | Change From Baseline at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the Overall Study Population | MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease Outcome measure is reported for the overall population. | Full Analysis Set (FAS): all participants randomized who received at least one dose of investigational product (IP) in the study and had baseline and at least one post-baseline observations. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
| |
| Secondary | Change From Baseline in Myasthenia Gravis Quality of Life-15, Revised (MGQOL-15r) Score at Week 26 in the Overall Study Population | MGQOL-15r score is a validated, patient-scored instrument, which measures the impact of MG on health-related quality of life (HRQoL). The 15 items in the questionnaire evaluate mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains. Each item is rated on a 3-point scale ranging from 0 ("not at all") to 2 ("very much") based on their experience "over the past few weeks." Items scores are summed to generate a total score ranging from 0-45, with higher score indicating worse HRQoL. Outcome measure is reported for the overall population. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
| |
| Secondary | Change From Baseline in MGQOL-15r Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | MGQOL-15r score is a validated, patient-scored instrument, which measures the impact of MG on health-related quality of life (HRQoL). The 15 items in the questionnaire evaluate mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains. Each item is rated on a 3-point scale ranging from 0 ("not at all") to 2 ("very much") based on their experience "over the past few weeks." Items scores are summed to generate a total score ranging from 0-45, with higher score indicating worse HRQoL. Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab+: Placebo |
|
| Secondary | Change From Baseline in MGQOL-15r Score at Week 52 in Anti-AChR-Ab+ Population | MGQOL-15r score is a validated, patient-scored instrument, which measures the impact of MG on health-related quality of life (HRQoL). The 15 items in the questionnaire evaluate mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains. Each item is rated on a 3-point scale ranging from 0 ("not at all") to 2 ("very much") based on their experience "over the past few weeks." Items scores are summed to generate a total score ranging from 0-45, with higher score indicating worse HRQoL. Outcome Measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Baseline and Week 52 | | Participants | | | | |
| Secondary | Percentage of Participants With Patient Global Impression of Change (PGIC) Scores at Week 26 in the Overall Study Population | The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a participant's rating of overall improvement. Participant rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse", Outcome measure is reported for the overall population. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Count of Participants | | Participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
| |
| Secondary | Percentage of Participants With PGIC Scores at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Count of Participants | | Participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab: Placebo | Anti-MuSK-Ab+ participants received placebo IV on Day 1 and Day 15 in the RCP. | |
|
| Secondary | Percentage of Participants With PGIC Scores at Week 52 in Anti-AChR-Ab+ Population | The self-report measure PGIC score reflects a participant's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a participant's rating of overall improvement. participants rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Week 52 | | Participants | | | | |
| Secondary | Percentage of Participants Experiencing Exacerbation by Week 26 in the Overall Study Population | An exacerbation was defined as one of the following:
- Use of protocol defined rescue therapy, or
- Myasthenic crisis, defined as worsening of myasthenic weakness requiring intubation or non-invasive ventilation to avoid intubation, except when these measures are employed during routine postoperative management, or
- Significant symptomatic worsening to a score of 3 or a 2-point worsening from baseline on any one of the individual MG-ADL items other than double vision or eyelid droop.
Outcome measure is reported for the overall population. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Count of Participants | | Participants | | Up to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
| |
| Secondary | Percentage of Participants Experiencing Exacerbation by Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | An exacerbation was defined as one of the following:
- Use of protocol defined rescue therapy, or
- Myasthenic crisis, defined as worsening of myasthenic weakness requiring intubation or non-invasive ventilation to avoid intubation, except when these measures are employed during routine postoperative management, or
- Significant symptomatic worsening to a score of 3 or a 2-point worsening from baseline on any one of the individual MG-ADL items other than double vision or eyelid droop.
Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Count of Participants | | Participants | | Up to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab+: Placebo | |
|
| Secondary | Percentage of Participants Experiencing Exacerbation by Week 52 in Anti-AChR-Ab+ Population | An exacerbation was defined as one of the following:
- Use of protocol defined rescue therapy, or
- Myasthenic crisis, defined as worsening of myasthenic weakness requiring intubation or non-invasive ventilation to avoid intubation, except when these measures are employed during routine postoperative management, or
- Significant symptomatic worsening to a score of 3 or a 2-point worsening from baseline on any one of the individual MG-ADL items other than double vision or eyelid droop.
Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Up to Week 52 | | Participants | | | | |
| Secondary | Percentage of Participants Achieving Minimal Symptom Expression (MSE) at Week 26 | MSE was defined as MG-ADL= 0 or 1. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. | Posted | | Count of Participants | | Participants | | From Day 28 to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+participants receivedplacebo IV on Day 1,Day 15 and Day 183(Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+:Inebilizumab 300 mg | Anti-AChR-Ab+participants receivedinebilizumab IV on Day1, Day 15 and Day 183(Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab+: Placebo | Anti-MuSK-Ab+participants receivedplacebo IV on Day 1 andDay 15 in the RCP. | | OG003 | Anti-MuSK-Ab+:Inebilizumab 300 mg | Anti-MuSK-Ab+participants receivedinebilizumab IV on Day 1and Day 15 in the RCP. |
|
| Secondary | Percentage of Participants With Steroid Tapered to ≤ 5 mg/Day Steroid at Week 26 in the Overall Study Population | Outcome measure is reported for the overall population. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. Outcome measure refers to participants with baseline steroids> 5 mg. | Posted | | Count of Participants | | Participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
| |
| Secondary | Percentage of Participants With Steroid Tapered to ≤ 5 mg/Day Steroid at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. Outcome measure refers to participants with baseline steroids> 5 mg. | Posted | | Count of Participants | | Participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab+: Placebo | Anti-MuSK-Ab+ participants received placebo IV on Day 1 and Day 15 in the RCP. | | OG003 | Anti-MuSK-Ab+: Inebilizumab 300 mg | Anti-MuSK-Ab+ participants received inebilizumab IV on Day 1 and Day 15 in the RCP. |
|
| Secondary | Percentage of Participants With Steroid Tapered to ≤ 5 mg/Day Steroid at Week 52 in Anti-AChR-Ab+ Population | Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Week 52 | | Participants | | | | |
| Secondary | Percentage of Participants Who Achieved ≥ 50% Steroid Reduction at Week 26 in the Overall Study Population | Outcome measure is reported for the overall population. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. Outcome Measure refers to participants with baseline steroids> 5 mg. | Posted | | Count of Participants | | Participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
| |
| Secondary | Percentage of Participants Who Achieved ≥ 50% Steroid Reduction at Week 26 in the Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | FAS: all participants randomized who received at least one dose of IP in the study and had baseline and at least one post-baseline observations. Outcome Measure refers to participants with baseline steroids> 5 mg. | Posted | | Count of Participants | | Participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab+: Placebo | Anti-MuSK-Ab+ participants received placebo IV on Day 1 and Day 15 in the RCP. | | OG003 | Anti-MuSK-Ab+: Inebilizumab 300 mg | Anti-MuSK-Ab+ participants received inebilizumab IV on Day 1 and Day 15 in the RCP. |
|
| Secondary | Percentage of Participants Who Achieved ≥ 50% Steroid Reduction at Week 52 in the Anti-AChR-Ab+ Population | Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | Week 52 | | Participants | | | | |
| Secondary | Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), AE of Special Interest (AESIs) and Serious TEAEs (SAEs). | An AE is any untoward medical occurrence associated with the use of the IP, whether or not it is considered related. Clinically significant changes from baseline in clinical laboratory results, vital signs and ECGs were also reported as AEs. An AESI is an event of medical interest specific to the understanding of the IP and which may require close monitoring and collection of additional information. A SAE is considered "serious" if it results in any of the following outcomes:
- Death;
- A life-threatening AE. An event is considered "life-threatening" if its occurrence places the patient or subject at immediate risk of death;
- Inpatient hospitalization or prolongation of existing hospitalization;
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
- A congenital anomaly/birth defect;
- May require medical or surgical intervention to prevent one of the outcomes listed in this definition.
| Safety Analyses Set: all participants who received any dose of IP during the RCP. | Posted | | Count of Participants | | Participants | | For RCP AE reporting: from Day 1 to the end of RCP or cutoff date (up to 65.4 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg |
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| Secondary | Percentage of Participants With Anti-drug Antibodies (ADA) by Week 26 in the Overall Study Population | Treatment emergent ADA were defined as ADA positive post-baseline only or boosted pre-existing ADA titer. Outcome measure is reported for the overall population. | Safety Analyses Set: all participants who received any dose of IP during RCP. | Posted | | Count of Participants | | Participants | | From Baseline to Week 26 | | | | ID | Title | Description |
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| OG000 | Overall: Placebo | All participants received placebo IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received placebo IV on Day 183 (Week 26). | | OG001 | Overall: Inebilizumab 300 mg | All participants received inebilizumab IV on Days 1 and 15. Participants with Anti-AChR-Ab+ also received inebilizumab IV on Day 183 (Week 26). |
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| Secondary | Percentage of Participants With ADA by Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | Treatment emergent ADA were defined as ADA positive post-baseline only or boosted pre-existing ADA titer. Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | Safety Analyses Set: all participants who received any dose of IP during RCP. | Posted | | Count of Participants | | Participants | | From Baseline to Week 26 | | | | ID | Title | Description |
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| OG000 | Anti-AChR-Ab+: Placebo | Anti-AChR-Ab+ participants received placebo IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG002 | Anti-MuSK-Ab+: Placebo | Anti-MuSK-Ab+ participants received placebo IV on Day 1 and Day 15 in the RCP. | | OG003 | Anti-MuSK-Ab+: Inebilizumab 300 mg | Anti-MuSK-Ab+ participants received inebilizumab IV on Day 1 and Day 15 in the RCP. |
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| Secondary | Percentage of Participants With ADA by Week 52 in Anti-AChR-Ab+ Population | Treatment emergent ADA were defined as ADA positive post-baseline only or boosted pre-existing ADA titer. Outcome measure is reported for the Anti-AChR-Ab+ population. | | Not Posted | Nov 2028 | | | | | From Baseline to Week 52 | | Participants | | | | |
| Secondary | Time to Maximum Serum Concentration (Tmax) of Inebilizumab in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | On inebilizumab dosing days, inebilizumab pharmacokinetic (PK) serum samples were collected pre-dose and approximately 15 minutes (± 5 minutes) after completion of the IP infusion. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | PK Analysis Set: all participants who received IP and had at least one quantifiable serum PK observation post first dose. | Posted | | Median | Full Range | day | | Days 1 and 15 for Anti-MuSK-Ab+ population; Days 1, 15 and 183 (Week 26) for Anti-AChR-Ab+ population | | | | ID | Title | Description |
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| OG000 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-MuSK-Ab+: Inebilizumab 300 mg | Anti-MuSK-Ab+ participants received inebilizumab IV on Day 1 and Day 15 in the RCP. |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Inebilizumab in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations | On inebilizumab dosing days, inebilizumab PK serum samples were collected pre-dose and approximately 15 minutes (± 5 minutes) after completion of the IP infusion. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | PK Analysis Set: all participants who received IP and had at least one quantifiable serum PK observation post first dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug/mL | | Days 1 and 15 for Anti-MuSK-Ab+ population; Days 1, 15 and 183 (Week 26) for Anti-AChR-Ab+ population | | | | ID | Title | Description |
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| OG000 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-MuSK-Ab+: Inebilizumab 300 mg | Anti-MuSK-Ab+ participants received inebilizumab IV on Day 1 and Day 15 in the RCP. |
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| Secondary | Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab | On inebilizumab dosing days, inebilizumab PK serum samples were collected pre-dose and approximately 15 minutes (± 5 minutes) after completion of the IP infusion. Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations. | PK Analysis Set: all participants who received IP and had at least one quantifiable serum PK observation post first dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ug*day/mL | | Days 1 and 15 for Anti-MuSK-Ab+ population; Days 1, 15 and 183 (Week 26) for Anti-AChR-Ab+ population | | | | ID | Title | Description |
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| OG000 | Anti-AChR-Ab+: Inebilizumab 300 mg | Anti-AChR-Ab+ participants received inebilizumab IV on Day 1, Day 15 and Day 183 (Week 26) in the RCP. | | OG001 | Anti-MuSK-Ab+: Inebilizumab 300 mg | Anti-MuSK-Ab+ participants received inebilizumab IV on Day 1 and Day 15 in the RCP. |
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