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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04660539
Other study ID # WN42349
Secondary ID 2020-003413-35
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2, 2021
Est. completion date May 28, 2024

Study information

Verified date June 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date May 28, 2024
Est. primary completion date May 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
satralizumab
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
azathioprine (AZA)
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)
mycophenolate mofetil (MMF)
Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day
oral corticosteroids
Participants are permitted to use oral corticosteroids (prednisolone equivalent) during the study as background immunosuppressive treatment at a maximum dose of 15 mg/day

Locations

Country Name City State
Bulgaria UMHAT 'Dr. Georgi Stranski', EAD Pleven
Bulgaria Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Aleksandrovska EAD Sofia
Canada Centre hospitalier de l'Universite de Montreal (CHUM) Montreal Quebec
Canada MS Clinical Trials Group Vancouver British Columbia
Croatia Clinical Hospital Centre Osijek Osijek
Germany Ruhr Universitat Bochum Bochum
Hungary Jahn Ferenc Del-Pesti Korhaz es Rendelointezet Budapest
Italy Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Catania Sicilia
Italy Azienda Ospedaliera Sant'Andrea Roma Lazio
Japan Kyushu University Hospital Fukuoka
Japan Tohoku University Hospital Miyagi
Japan Niigata University Medical & Dental Hospital Niigata
Japan Kindai University Hospital Osaka
Japan Osaka University Hospital Osaka
Japan National Center of Neurology and Psychiatry Tokyo
Japan Tokyo Women's Medical University Hospital Tokyo
Korea, Republic of Asan Medical Center - PPDS Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Malaysia Hospital Kuala Lumpur Kuala Lumpur FED. Territory OF Kuala Lumpur
Poland M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM Katowice
Poland NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS Katowice
Poland Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; Klinika Neurologii Lublin
Poland Instytut Psychiatrii i Neurologii Warszawa
Poland Miedzyleski Szpital Specjalistyczny w Warszawie Warszawa
Poland Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny; Klinika Neurologii Warszawa
Puerto Rico San Juan MS Center Guaynabo
Romania SC Clubul Sanatatii SRL Campulung
Spain Hospital Clinic de Barcelona Barcelona
Spain Hosp. Clinico San Carlos Madrid
Taiwan China Medical University Hospital North Dist.
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei City
Turkey Bilim University Medical Faculty Florence Nightingale Hospital Istanbul
Ukraine Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council Dnipro Katerynoslav Governorate
Ukraine Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council Odesa Kherson Governorate
Ukraine Communal Nonprofit enterprise Ternopil Regional Clinical Psychoneurological Hospital of TRC Ternopil Volhynian Governorate
Ukraine Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC Vinnytsia Podolia Governorate
United Kingdom National Hospital For Neurology and Neurosurgery London
United States Children's Hospital of Alabama Birmingham Alabama
United States The Neurological Institute PA Charlotte North Carolina
United States University of Chicago Chicago Illinois
United States Columbus Research and Wellness Columbus Georgia
United States OhioHealth Research Institute Columbus Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States Wayne State University; UHC-4H Detroit Michigan
United States University of Kansas Medical Center Kansas City Kansas
United States University of Miami Miami Florida
United States Consultants in Neurology Ltd Northbrook Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Jefferson Hospital For Neuroscience; Jefferson Neurology Associates Philadelphia Pennsylvania
United States Central Texas Neurology Consultants Round Rock Texas

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Croatia,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Poland,  Puerto Rico,  Romania,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Adverse Events (AE) AEs of Special Interest (AESI), Serious AEs (SAE), and Selected AEs Up to 39 Months
Secondary Columbia-Suicide Severity Rating Scale (C-SSRS) Scores Up to39 months
Secondary Percentage of Participants with Serious Infections and Hepatotoxicity Participants with NMOSD who are treated with satralizumab Up to 39 Months
Secondary Time to First Relapse (TFR) Up to 39 Months
Secondary Percentage of Relapse-Free Participants Up to 39 Months
Secondary Annualized Relapse Rate (ARR) Up to 39 Months
Secondary Change in Expanded Disability Status Scale (EDSS) Score Up to 39 Months
Secondary Time to EDSS Worsening Up to 39 Months
Secondary Percentage of Participants without EDSS Worsening Up to 39 Months
Secondary 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 Up to 39 Months
Secondary Concentrations of Interleukin-6 (IL-6) and Soluble IL-6 Receptor (sIL-6R) in Blood Measured in picogram per milliliter (pg/mL) Up to 39 Months
Secondary Concentration of C-Reactive Protein (CRP) in Blood Measured in milligram per liter (mg/L) Up to 39 Months
Secondary Serum Concentration of Satralizumab at Specified Timepoints Up to 39 Months
Secondary Percentage of Participants with Anti-Drug Antibodies (ADAs) from the First Dose of Satralizumab in Studies BN40898 or BN40900 (parent studies) Up to 39 Months
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