A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis Optica Spectrum Disorder Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04660539
• Other study ID #: WN42349
• Secondary ID: 2020-003413-35
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2, 2021
• Est. completion date: May 25, 2024

Study information

• Verified date: March 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• Enrollment: 119
• Est. completion date: May 25, 2024
• Est. primary completion date: May 25, 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

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

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	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