Trial · NCT04963270
A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
NCT04963270, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2025-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis. Trials, record NCT04963270. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04963270
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
- NCT number
- NCT04963270
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 188 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Generalized Myasthenia Gravis
- Interventions
- Satralizumab, Placebo
- First posted
- 2021-07-15
- Last updated
- 2025-02-28
- Results first posted
- 2025-02-28
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | DB Period: Mean Change From Baseline in Total Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the AChR+ Population | At Week 24 | The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. |
| Secondary | DB Period: Mean Change From Baseline in Total MG-ADL Score in the Overall Population (OP) at Week 24 | At Week 24 | The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. |
| Secondary | DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in AChR+ Population at Week 24 | At Week 24 | The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. Participants who received rescue therapy were considered non-responders. |
| Secondary | DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in OP at Week 24 | At Week 24 | The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. Participants who received rescue therapy were considered non-responders. |
| Secondary | DB Period: Mean Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score in AChR+ Population at Week 24 | At Week 24 | The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity. |
| Secondary | DB Period: Mean Change From Baseline in QMG Score in OP at Week 24 | At Week 24 | The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity. |
| Secondary | DB Period: Mean Change From Baseline in Myasthenia Gravis Quality of Life 15 Scale (Revised) (MG-QOL 15r) Total Score in AChR+ Population at Week 24 | At Week 24 | The MG-QOL-15r is a disease-specific health-related QoL measure that consists of 15 items: mobility (9 items), symptoms (3 items), and contentment and emotional well-being (3 items). Items were scored on a scale from 0=Not at all to 2=Very much with the total score ranging from 0 to 30 and higher scores indicate worse health-related quality of life (HRQoL). |
| Secondary | DB Period: Mean Change From Baseline in MG-QOL 15r Total Score in OP at Week 24 | At Week 24 | The MG-QOL-15r is a disease-specific health-related QoL measure that consists of 15 items: mobility (9 items), symptoms (3 items), and contentment and emotional well-being (3 items). Items are scored on a scale from 0=Not at all to 2=Very much, with the total score ranging from 0 to 30 and higher scores indicate worse HRQoL. |
| Secondary | DB Period: Mean Change From Baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale Total Score in AChR+ Population at Week 24 | At Week 24 | The Neuro-QoL is a validated tool designed to evaluate the HRQoL in participants with chronic neurological disease. The Fatigue Subscale is implemented as an eight-item, stand-alone short form that assesses the multi-dimensional aspects of fatigue ranging from general tiredness to debilitating exhaustion that Impacts activities of daily living. Each item was assessed using a 5-level Likert scale ranging between 1=never to 5=always. Raw scores range from 8 to 40, higher values indicate greater fatigue. |
| Secondary | DB Period: Mean Change From Baseline in Neuro-QoL Fatigue Subscale Total Score in OP at Week 24 | At Week 24 | The Neuro-QoL is a validated tool designed to evaluate the HRQoL in participants with chronic neurological disease. The Fatigue Subscale is implemented as an eight-item, stand-alone short form that assesses the multi-dimensional aspects of fatigue ranging from general tiredness to debilitating exhaustion that Impacts activities of daily living. Each item was assessed using a 5-level Likert scale ranging between 1=never to 5=always. Raw scores range from 8 to 40, higher values indicate greater fatigue. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | DB Period: Mean Change From Baseline in Total Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the AChR+ Population | At Week 24 | AChR+ population included all participants in the study who were AChR+. | score on a scale | MEAN |
| SECONDARY | DB Period: Mean Change From Baseline in Total MG-ADL Score in the Overall Population (OP) at Week 24 | At Week 24 | Modified intent-to-treat (mIIT) population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized. | score on a scale | MEAN |
| SECONDARY | DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in AChR+ Population at Week 24 | At Week 24 | AChR+ population included all participants in the study who were AChR+. | percentage of participants | NUMBER |
| SECONDARY | DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in OP at Week 24 | At Week 24 | mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized. | percentage of participants | NUMBER |
| SECONDARY | DB Period: Mean Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score in AChR+ Population at Week 24 | At Week 24 | AChR+ population included all participants in the study who were AChR+. | score on a scale | MEAN |
| SECONDARY | DB Period: Mean Change From Baseline in QMG Score in OP at Week 24 | At Week 24 | mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized. | score on a scale | MEAN |
| SECONDARY | DB Period: Mean Change From Baseline in Myasthenia Gravis Quality of Life 15 Scale (Revised) (MG-QOL 15r) Total Score in AChR+ Population at Week 24 | At Week 24 | AChR+ population included all participants in the study who were AChR+. | score on a scale | MEAN |
| SECONDARY | DB Period: Mean Change From Baseline in MG-QOL 15r Total Score in OP at Week 24 | At Week 24 | mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized. | score on a scale | MEAN |
| SECONDARY | DB Period: Mean Change From Baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale Total Score in AChR+ Population at Week 24 | At Week 24 | AChR+ population included all participants in the study who were AChR+. | score on a scale | MEAN |
| SECONDARY | DB Period: Mean Change From Baseline in Neuro-QoL Fatigue Subscale Total Score in OP at Week 24 | At Week 24 | mIIT population included all participants that were part of the ITT and had a baseline and at least one post-baseline MG-ADL assessment during the DB period. This excludes adolescents who joined the study after the last adult participant was randomized. | score on a scale | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group133
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| DB Period: Mean Change From Baseline in Total Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the AChR+ Population | Placebo | -2.57 | Standard Error 0.35 | score on a scale | |
| DB Period: Mean Change From Baseline in Total Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the AChR+ Population | Satralizumab | -3.59 | Standard Error 0.29 | score on a scale | |
| DB Period: Mean Change From Baseline in Total MG-ADL Score in the Overall Population (OP) at Week 24 | Placebo | -2.52 | Standard Error 0.32 | score on a scale | |
| DB Period: Mean Change From Baseline in Total MG-ADL Score in the Overall Population (OP) at Week 24 | Satralizumab | -3.54 | Standard Error 0.28 | score on a scale | |
| DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in AChR+ Population at Week 24 | Placebo | 58.8 | 95% Confidence Interval 47.9 to 69.6 | percentage of participants | |
| DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in AChR+ Population at Week 24 | Satralizumab | 70.9 | 95% Confidence Interval 61.2 to 80.6 | percentage of participants | |
| DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in OP at Week 24 | Placebo | 60.7 | 95% Confidence Interval 50.4 to 70.9 | percentage of participants | |
| DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in OP at Week 24 | Satralizumab | 69.8 | 95% Confidence Interval 60.5 to 79 | percentage of participants | |
| DB Period: Mean Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score in AChR+ Population at Week 24 | Placebo | -1.78 | Standard Error 0.46 | score on a scale | |
| DB Period: Mean Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score in AChR+ Population at Week 24 | Satralizumab | -3.41 | Standard Error 0.41 | score on a scale |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period (24 Weeks) | STARTED | Placebo | 92 | |
| Double-Blind Period (24 Weeks) | STARTED | Satralizumab | 96 | |
| Double-Blind Period (24 Weeks) | STARTED | Placebo (DB) to Satralizumab (OLE) | 0 | |
| Double-Blind Period (24 Weeks) | STARTED | Satralizumab (DB) to Satralizumab (OLE) | 0 | |
| Double-Blind Period (24 Weeks) | COMPLETED | Placebo | 88 | |
| Double-Blind Period (24 Weeks) | COMPLETED | Satralizumab | 92 | |
| Double-Blind Period (24 Weeks) | COMPLETED | Placebo (DB) to Satralizumab (OLE) | 0 | |
| Double-Blind Period (24 Weeks) | COMPLETED | Satralizumab (DB) to Satralizumab (OLE) | 0 | |
| Double-Blind Period (24 Weeks) | NOT COMPLETED | Placebo | 4 | |
| Double-Blind Period (24 Weeks) | NOT COMPLETED | Satralizumab | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events275
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | DB Period: Placebo | 1 | 92 | 1 |
| other | Vertigo | Ear and labyrinth disorders | DB Period: Satralizumab 120mg | 2 | 87 | 2 |
| other | Vertigo | Ear and labyrinth disorders | DB Period: Satralizumab 180mg | 0 | 9 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Overall Satralizumab 120mg | 2 | 159 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Overall Satralizumab 180mg | 2 | 25 | 2 |
| other | Diplopia | Eye disorders | DB Period: Placebo | 0 | 92 | 0 |
| other | Diplopia | Eye disorders | DB Period: Satralizumab 120mg | 0 | 87 | 0 |
| other | Diplopia | Eye disorders | DB Period: Satralizumab 180mg | 1 | 9 | 1 |
| other | Diplopia | Eye disorders | Overall Satralizumab 120mg | 0 | 159 | 0 |
| other | Diplopia | Eye disorders | Overall Satralizumab 180mg | 1 | 25 | 1 |
1 to 10 of 275Source ClinicalTrials.gov
See all 275 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB Period: Placebo | 0 | 92 |
| Total, all-cause mortality | DB Period: Satralizumab 120mg | 0 | 87 |
| Total, all-cause mortality | DB Period: Satralizumab 180mg | 0 | 9 |
| Total, all-cause mortality | Overall Satralizumab 120mg | 1 | 159 |
| Total, all-cause mortality | Overall Satralizumab 180mg | 0 | 25 |
| Total, other adverse events | DB Period: Placebo | 40 | 92 |
| Total, other adverse events | DB Period: Satralizumab 120mg | 48 | 87 |
| Total, other adverse events | DB Period: Satralizumab 180mg | 8 | 9 |
| Total, other adverse events | Overall Satralizumab 120mg | 95 | 159 |
| Total, other adverse events | Overall Satralizumab 180mg | 16 | 25 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39862880 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04963270
GET https://conductscience.org/api/trials/v1/NCT04963270/registered?page=2