Back to resultsA Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Primary Purpose
Neuromyelitis Optica Spectrum Disorder
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
satralizumab
azathioprine (AZA)
mycophenolate mofetil (MMF)
oral corticosteroids
Sponsored by
About this trial
This is an interventional treatment trial for Neuromyelitis Optica Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- Participants aged less than 18 years at the time of informed consent for Study BN40898 can continue treatment with a combination of oral corticosteroids and either AZA or MMF
- Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were anti-aquaporin-4 IgG antibody (AQP4-IgG) seropositive at screening in these studies. Participants with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the participant
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab.
Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug
- Evidence of any serious uncontrolled concomitant diseases that may preclude participation including nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
- Known active infection that requires delaying the next satralizumab dose at the time of enrollment
- NMOSD relapse at the time of enrollment
- Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab
Sites / Locations
- Children's Hospital of Alabama
- University of Miami
- Columbus Research and Wellness
- University of Chicago
- Consultants in Neurology Ltd
- OSF Saint Francis Medical Center
- University of Kansas Medical Center
- Wayne State University; UHC-4H
- The Neurological Institute PA
- OhioHealth Research Institute
- Jefferson Hospital For Neuroscience; Jefferson Neurology Associates
- University of Texas Southwestern Medical Center
- Central Texas Neurology Consultants
- UMHAT 'Dr. Georgi Stranski', EAD
- Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
- University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
- MS Clinical Trials Group
- Centre hospitalier de l'Universite de Montreal (CHUM)
- Clinical Hospital Centre Osijek
- Ruhr Universitat Bochum
- Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
- Azienda Ospedaliera Sant'Andrea
- Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
- Kyushu University Hospital
- Tohoku University Hospital
- Niigata University Medical & Dental Hospital
- Osaka University Hospital
- Kindai University Hospital
- Tokyo Women's Medical University Hospital
- National Center of Neurology and Psychiatry
- Korea University Anam Hospital
- Asan Medical Center - PPDS
- Hospital Kuala Lumpur
- NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
- M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; Klinika Neurologii
- Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny
- Instytut Psychiatrii i Neurologii
- Miedzyleski Szpital Specjalistyczny w Warszawie
- San Juan MS Center
- SC Clubul Sanatatii SRL
- Hospital Clinic de Barcelona
- Hosp. Clinico San Carlos
- China Medical University Hospital
- National Cheng Kung University Hospital
- Taipei Veterans General Hospital
- National Taiwan University Hospital
- Bilim University Medical Faculty Florence Nightingale Hospital
- Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council
- Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council
- Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC
- Communal Nonprofit enterprise Ternopil Regional Clinical Psychoneurological Hospital of TRC
- National Hospital For Neurology and Neurosurgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Satralizumab Treatment
Arm Description
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
Outcomes
Primary Outcome Measures
Percentage of Participants with Adverse Events (AE) AEs of Special Interest (AESI), Serious AEs (SAE), and Selected AEs
Secondary Outcome Measures
Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Percentage of Participants with Serious Infections and Hepatotoxicity
Participants with NMOSD who are treated with satralizumab
Time to First Relapse (TFR)
Percentage of Relapse-Free Participants
Annualized Relapse Rate (ARR)
Change in Expanded Disability Status Scale (EDSS) Score
Time to EDSS Worsening
Percentage of Participants without EDSS Worsening
Change in Visual Acuity Assessed by a Snellen 20-Foot Wall Chart
The test will be performed monocularly and participants may use their habitual distance glasses or contact lenses
Concentrations of Interleukin-6 (IL-6) and Soluble IL-6 Receptor (sIL-6R) in Blood
Measured in picogram per milliliter (pg/mL)
Concentration of C-Reactive Protein (CRP) in Blood
Measured in milligram per liter (mg/L)
Serum Concentration of Satralizumab at Specified Timepoints
Percentage of Participants with Anti-Drug Antibodies (ADAs) from the First Dose of Satralizumab in Studies BN40898 or BN40900 (parent studies)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04660539
Brief Title
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Official Title
A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
May 25, 2024 (Anticipated)
Study Completion Date
May 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Satralizumab Treatment
Arm Type
Experimental
Arm Description
Participants will receive satralizumab subcutaneously (SC) every 4 weeks (Q4W)
Intervention Type
Drug
Intervention Name(s)
satralizumab
Other Intervention Name(s)
Enspryng
Intervention Description
Satralizumab will be administered by SC injection in the abdominal or femoral region at a dose of 120 mg (fixed dose) Q4W for up to 3 years
Intervention Type
Drug
Intervention Name(s)
azathioprine (AZA)
Other Intervention Name(s)
non-investigational medicinal product (NIMP)
Intervention Description
Participants are permitted to use AZA during the study as background immunosuppressive treatment at a maximum dose of 3 milligram per kilogram per day (mg/kg/day)
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil (MMF)
Other Intervention Name(s)
NIMP
Intervention Description
Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day
Intervention Type
Drug
Intervention Name(s)
oral corticosteroids
Other Intervention Name(s)
NIMP
Intervention Description
Participants are permitted to use oral corticosteroids (prednisolone equivalent) during the study as background immunosuppressive treatment at a maximum dose of 15 mg/day
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AE) AEs of Special Interest (AESI), Serious AEs (SAE), and Selected AEs
Time Frame
Up to 39 Months
Secondary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Time Frame
Up to39 months
Title
Percentage of Participants with Serious Infections and Hepatotoxicity
Description
Participants with NMOSD who are treated with satralizumab
Time Frame
Up to 39 Months
Title
Time to First Relapse (TFR)
Time Frame
Up to 39 Months
Title
Percentage of Relapse-Free Participants
Time Frame
Up to 39 Months
Title
Annualized Relapse Rate (ARR)
Time Frame
Up to 39 Months
Title
Change in Expanded Disability Status Scale (EDSS) Score
Time Frame
Up to 39 Months
Title
Time to EDSS Worsening
Time Frame
Up to 39 Months
Title
Percentage of Participants without EDSS Worsening
Time Frame
Up to 39 Months
Title
Change in Visual Acuity Assessed by a Snellen 20-Foot Wall Chart
Description
The test will be performed monocularly and participants may use their habitual distance glasses or contact lenses
Time Frame
Up to 39 Months
Title
Concentrations of Interleukin-6 (IL-6) and Soluble IL-6 Receptor (sIL-6R) in Blood
Description
Measured in picogram per milliliter (pg/mL)
Time Frame
Up to 39 Months
Title
Concentration of C-Reactive Protein (CRP) in Blood
Description
Measured in milligram per liter (mg/L)
Time Frame
Up to 39 Months
Title
Serum Concentration of Satralizumab at Specified Timepoints
Time Frame
Up to 39 Months
Title
Percentage of Participants with Anti-Drug Antibodies (ADAs) from the First Dose of Satralizumab in Studies BN40898 or BN40900 (parent studies)
Time Frame
Up to 39 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants aged less than 18 years at the time of informed consent for Study BN40898 can continue treatment with a combination of oral corticosteroids and either AZA or MMF
Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were anti-aquaporin-4 IgG antibody (AQP4-IgG) seropositive at screening in these studies. Participants with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the participant
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab.
Exclusion Criteria:
Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug
Evidence of any serious uncontrolled concomitant diseases that may preclude participation including nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
Known active infection that requires delaying the next satralizumab dose at the time of enrollment
NMOSD relapse at the time of enrollment
Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Columbus Research and Wellness
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Consultants in Neurology Ltd
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
64637
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Wayne State University; UHC-4H
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
The Neurological Institute PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Jefferson Hospital For Neuroscience; Jefferson Neurology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-0001
Country
United States
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
MS Clinical Trials Group
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
Centre hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Clinical Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Ruhr Universitat Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
National Center of Neurology and Psychiatry
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
FED. Territory OF Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; Klinika Neurologii
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Miedzyleski Szpital Specjalistyczny w Warszawie
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
San Juan MS Center
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Facility Name
SC Clubul Sanatatii SRL
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
China Medical University Hospital
City
North Dist.
ZIP/Postal Code
40402
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Bilim University Medical Faculty Florence Nightingale Hospital
City
Istanbul
ZIP/Postal Code
34333
Country
Turkey
Facility Name
Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council
City
Dnipro
State/Province
Katerynoslav Governorate
ZIP/Postal Code
49069
Country
Ukraine
Facility Name
Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council
City
Odesa
State/Province
Kherson Governorate
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC
City
Vinnytsia
State/Province
Podolia Governorate
ZIP/Postal Code
21037
Country
Ukraine
Facility Name
Communal Nonprofit enterprise Ternopil Regional Clinical Psychoneurological Hospital of TRC
City
Ternopil
State/Province
Volhynian Governorate
ZIP/Postal Code
46027
Country
Ukraine
Facility Name
National Hospital For Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)
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