Trial · NCT04660539
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
NCT04660539, Phase 3, Completed, Hoffmann-La Roche; results first posted 2024-12-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD). Trials, record NCT04660539. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04660539
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
- NCT number
- NCT04660539
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 119 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Interventions
- satralizumab, azathioprine (AZA), mycophenolate mofetil (MMF), oral corticosteroids
- First posted
- 2020-12-09
- Last updated
- 2024-12-27
- Other registries' IDs
- eudract:2020-003413-35
- Results first posted
- 2024-12-27
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 523 weeks | AE=any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with it. AE can therefore be any unfavorable \& unintended sign, symptoms/disease temporally associated with use of a medicinal (investigational) product, whether or not considered related to it. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here. |
| Primary | Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs | Baseline up to 523 weeks | An AESIs included potential drug induced liver injury and suspected transmission of an infectious agent by study drug defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic causing clinical symptoms or laboratory findings that indicate an infection in a participant exposed to a medicinal product. Selected AEs included infections that required treatments with IV antibiotics, antifungals, or antivirals; opportunistic infections that required treatment with oral antibiotics, antifungals, or antivirals and injection related reaction. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All AEs from the time of randomization in the parent studies for satralizumab-treated participants are reported here. |
| Secondary | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to 523 weeks | C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior \& attempts with actual/potential lethality. Categories have binary responses (yes/no) \& include a-Wish to be Dead; b-Non-specific Active Suicidal Thoughts; c-Active Suicidal Ideation with Any Methods(Not Plan) without Intent to Act; d-Active Suicidal Ideation with Some Intent to Act, without Specific Plan; e-Active Suicidal Ideation with Specific Plan \& Intent, f-Preparatory Acts \& Behavior; g-Aborted Attempt; h-Interrupted Attempt; i-Actual Attempt(non-fatal); j-Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. |
| Secondary | Number of Participants With Serious Infections and Hepatotoxicity | Baseline up to 523 weeks | Hepatotoxicity was defined using the following Medical Dictionary for Regulatory Activities Standardised MedDRA Queries (MedDRA SMQs) - Cholestasis and jaundice of hepatic origin (SMQ narrow) and Drug related hepatic disorders - severe events only (SMQ narrow). The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279 ) was considered as baseline for this outcome measure. Data for all serious infections and hepatotoxicity from the time of randomization in the parent studies for satralizumab-treated participants are reported here. |
| Secondary | Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR) | Baseline up to 528 weeks | Time to first relapse (TFR) was defined as the time from randomization in parent studies to the first occurrence of the first iPDR. PDR=occurrence of new or worsening neurological symptoms attributable to neurological neuromyelitis optica (NMO) or NMOSD. New or worsening neurological symptoms that occur \< 31 days following onset of PDR were considered part of same relapse. The time point of relapse onset=time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). For participants who did not relapse at the time of analysis, TFR was censored at the clinical cutoff date (CCOD) or at the time of withdrawal from study. The first dosing visit in current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline. All TFR data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. |
| Secondary | iPDR-free Rate up to Week 456 | Baseline up to Week 456 | iPDR free rate was defined as the percentage of participants who did not experience a protocol-defined relapse as assessed by the investigator. Protocol-defined relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \< 31 days following the onset of a PDR were considered part of the same relapse. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. All data from the time of randomization in the parent studies up to Week 456 for satralizumab-treated participants are reported here. Percentages have been rounded off to the nearest decimal point. Kaplan-Meier method was used to estimate the iPDR-free rates. |
| Secondary | Percentage of Relapse-Free Participants | Baseline up to 528 weeks | Protocol-defined relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \< 31 days following the onset of a PDR were considered part of the same relapse. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT0207327) was considered as baseline for this outcome measure. All data from the time of randomization in the parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. Participants who did not experience any relapse events are reported here. Percentages have been rounded off to the nearest decimal point. |
| Secondary | Annualized Relapse Rate (ARR) | Baseline up to 528 weeks | ARR was calculated as total number of relapses experienced divided by the participant-years of the whole study period. Adjusted ARR was calculated using Poisson regression model adjusted by study identifier (BN40898, BN40900). ARR was assessed from randomization in parent studies to the first occurrence of the iPDR. PDR=occurrence of new/worsening neurological symptoms attributable to NMO/NMOSD. New or worsening neurological symptoms that occur \< 31 days following onset of a PDR were considered part of the same relapse. Time point of relapse onset=the time at which the participant experienced any new or worsening neurological symptoms representing NMOSD clinical relapse(s). First dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All ARR data from time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. |
| Secondary | Change in Expanded Disability Status Scale (EDSS) Score | Baseline and every 24 weeks (up to 528 weeks) | EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. Baseline is the last observation on or before the day of first study drug administration in the current study or the parent studies (NCT02028884/NCT02073279). All EDSS data from the time of randomization in the parent studies up to the end of study WN42349 for satralizumab-treated participants are reported here. |
| Secondary | Time to First EDSS Scores Worsening | Baseline up to 528 weeks | EDSS=quantitative measure of disability \& for assessment of severity of relapse for participants with NMOSD. Values from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores=increased disability. EDSS worsening=(a) worsening of 2/more points in EDSS score for participants with a baseline score (BS) of 0, (b) worsening of 1/more points in EDSS score for participants with a BS of 1 to 5, or (c) worsening of 0.5 points/more in EDSS score for participants with a BS of 5.5/more. Participants were censored at date of last EDSS assessment or if no EDSS assessment was performed at randomization date. Baseline=last observation on/before day of first study drug administration in current study/parent studies (NCT02028884/NCT02073279). All EDSS data from time of randomization in parent studies up to end of study WN42349 for satralizumab-treated participants are reported here. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 523 weeks | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs | Baseline up to 523 weeks | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to 523 weeks | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study. The first dosing visit in the current study or randomization visit in the parent studies (NCT02028884/NCT02073279) was considered as baseline for this outcome measure. All data from the time of randomization in the parent studies for satralizumab-treated participants are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Infections and Hepatotoxicity | Baseline up to 523 weeks | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Protocol-defined Relapse (PDR) as Assessed by Investigator (iPDR) | Baseline up to 528 weeks | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | weeks | MEDIAN |
| SECONDARY | iPDR-free Rate up to Week 456 | Baseline up to Week 456 | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Relapse-Free Participants | Baseline up to 528 weeks | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | percentage of participants | NUMBER |
| SECONDARY | Annualized Relapse Rate (ARR) | Baseline up to 528 weeks | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in current study. | relapses per participant-year | NUMBER |
| SECONDARY | Change in Expanded Disability Status Scale (EDSS) Score | Baseline and every 24 weeks (up to 528 weeks) | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in the current study. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | score on a scale | MEAN |
| SECONDARY | Time to First EDSS Scores Worsening | Baseline up to 528 weeks | All Participants-treated population included participants who received at least one dose of satralizumab at any time either during the parent studies or this study, irrespective of enrollment in the current study. Overall number analyzed is the number of participants with data available for analysis. | weeks | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group360
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Satralizumab | AEs | 162 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Satralizumab | SAEs | 44 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs | Satralizumab | AESIs | 0 | Participants | |
| Number of Participants With Adverse Events of Special Interest (AESIs) and Selected AEs | Satralizumab | Selected AEs | 0 | Participants | |
| Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Satralizumab | a- Baseline | 7 | Participants | |
| Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Satralizumab | a- Post-baseline | 5 | Participants | |
| Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Satralizumab | b- Baseline | 5 | Participants | |
| Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Satralizumab | b- Post-baseline | 2 | Participants | |
| Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Satralizumab | c- Baseline | 1 | Participants | |
| Number of Participants With Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Satralizumab | c- Post-baseline | 0 | Participants |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Satralizumab | 166 | |
| Overall Study | COMPLETED | Satralizumab | 106 | |
| Overall Study | NOT COMPLETED | Satralizumab | 60 |
Source ClinicalTrials.gov
Adverse events113
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 | Anaemia | Blood and lymphatic system disorders | Satralizumab | 15 | 166 | 19 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Satralizumab | 9 | 166 | 12 |
| other | Leukopenia | Blood and lymphatic system disorders | Satralizumab | 18 | 166 | 33 |
| other | Lymphopenia | Blood and lymphatic system disorders | Satralizumab | 10 | 166 | 27 |
| other | Neutropenia | Blood and lymphatic system disorders | Satralizumab | 16 | 166 | 26 |
| other | Abdominal pain upper | Gastrointestinal disorders | Satralizumab | 11 | 166 | 12 |
| other | Constipation | Gastrointestinal disorders | Satralizumab | 18 | 166 | 23 |
| other | Dental caries | Gastrointestinal disorders | Satralizumab | 10 | 166 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | Satralizumab | 21 | 166 | 42 |
| other | Nausea | Gastrointestinal disorders | Satralizumab | 21 | 166 | 27 |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Satralizumab | 0 | 166 |
| Total, other adverse events | Satralizumab | 155 | 166 |
| Total, serious adverse events | Satralizumab | 44 | 166 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40743487 | 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/NCT04660539
GET https://conductscience.org/api/trials/v1/NCT04660539/results?page=2