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)
Verified date | June 2024 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Bulgaria, Canada, Croatia, Germany, Hungary, Italy, Japan, Korea, Republic of, Malaysia, Poland, Puerto Rico, Romania, Spain, Taiwan, Turkey, Ukraine, United Kingdom,
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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