A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention

PHASE4TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

August 2, 2022

Primary Completion Date

October 26, 2023

Study Completion Date

October 26, 2023

Conditions
Neuromyelitis Optica Spectrum DisorderNMOSD
Interventions
DRUG

Satralizumab 120 mg

Satralizumab 120 mg will be administered as monotherapy (SC) in the abdominal or femoral region at Weeks 0, 2 (±3 days), 4 (±3 days), and then every 4 weeks (±3 days) till the last administration at Week 92 followed by a clinical evaluation at Week 96. The first dose at Weeks 0 (baseline visit) will be administered at the study site by the designated site staff during the scheduled study visit. The next dose at Week 2 will be self-administered by the patient under the supervision of a designated study staff at the study site. All the subsequent doses will be self-administered by the patient following training from a healthcare provider (for patients who are not able to administer satralizumab SC by themselves, support by a caregiver/nurse is advised).

Trial Locations (3)

10408

National Cancer Center, Goyang-si

55239

Ondokuz Mayis University School of Medicine, Samsun

66160

University of Kansas Medical Center, Kansas City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharmaceutical Co.

UNKNOWN

lead

Hoffmann-La Roche

INDUSTRY