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

PHASE3CompletedINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

March 2, 2021

Primary Completion Date

May 28, 2024

Study Completion Date

May 28, 2024

Conditions
Neuromyelitis Optica Spectrum Disorder
Interventions
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

DRUG

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)

DRUG

mycophenolate mofetil (MMF)

Participants are permitted to use MMF during the study as background immunosuppressive treatment at a maximum dose of 3000 mg/day

DRUG

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

Trial Locations (53)

112

Taipei Veterans General Hospital, Taipei

1113

Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD, Sofia

1204

Jahn Ferenc Del-Pesti Korhaz es Rendelointezet, Budapest

1431

University Multiprofile Hospital for Active Treatment Aleksandrovska EAD, Sofia

5800

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

10002

National Taiwan University Hospital, Taipei

19107

Jefferson Hospital For Neuroscience; Jefferson Neurology Associates, Philadelphia

21037

Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC, Vinnytsia

28040

Hosp. Clinico San Carlos, Madrid

28204

The Neurological Institute PA, Charlotte

31000

Clinical Hospital Centre Osijek, Osijek

31909

Columbus Research and Wellness, Columbus

33136

University of Miami, Miami

34333

Bilim University Medical Faculty Florence Nightingale Hospital, Istanbul

35233

Children's Hospital of Alabama, Birmingham

40402

China Medical University Hospital, North Dist.

43214

OhioHealth Research Institute, Columbus

44791

Ruhr Universitat Bochum, Bochum

46027

Communal Nonprofit enterprise Ternopil Regional Clinical Psychoneurological Hospital of TRC, Ternopil

48201

Wayne State University; UHC-4H, Detroit

49069

Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council, Dnipro

50586

Hospital Kuala Lumpur, Kuala Lumpur

60062

Consultants in Neurology Ltd, Northbrook

60637

University of Chicago, Chicago

64637

OSF Saint Francis Medical Center, Peoria

65006

Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council, Odesa

66160

University of Kansas Medical Center, Kansas City

70457

National Cheng Kung University Hospital, Tainan City

78681

Central Texas Neurology Consultants, Round Rock

95123

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania

115100

SC Clubul Sanatatii SRL, Campulung Muscel

75390-0001

University of Texas Southwestern Medical Center, Dallas

V6T 1Z3

MS Clinical Trials Group, Vancouver

H2X 0A9

Centre hospitalier de l'Universite de Montreal (CHUM), Montreal

00189

Azienda Ospedaliera Sant'Andrea, Rome

812-8582

Kyushu University Hospital, Fukuoka

980-8574

Tohoku University Hospital, Miyagi

951-8520

Niigata University Medical & Dental Hospital, Niigata

565-0871

Osaka University Hospital, Osaka

589-8511

Kindai University Hospital, Osaka

162-8666

Tokyo Women's Medical University Hospital, Tokyo

187-8551

National Center of Neurology and Psychiatry, Tokyo

40-123

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Katowice

40-571

M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM, Katowice

20-954

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; Klinika Neurologii, Lublin

02-097

Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny; Klinika Neurologii, Warsaw

02-957

Instytut Psychiatrii i Neurologii, Warsaw

04-749

Miedzyleski Szpital Specjalistyczny w Warszawie, Warsaw

00968

San Juan MS Center, Guaynabo

02841

Korea University Anam Hospital, Seoul

05505

Asan Medical Center - PPDS, Seoul

08036

Hospital Clinic de Barcelona, Barcelona

WC1N 3BG

National Hospital For Neurology and Neurosurgery, London

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04660539 - A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) | Biotech Hunter | Biotech Hunter