Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

April 2, 2024

Primary Completion Date

June 26, 2028

Study Completion Date

June 26, 2028

Conditions
Neuromyelitis Optica Spectrum Disorder
Interventions
OTHER

Blood tests

Participants will have blood tests done at each scheduled visit (approximately every 6 months).

DRUG

Inebilizumab

Participants with NMOSD who previously enrolled in N-MOmentum study, who participated for at least 2 years in the open label phase (OLP) of the study, and participants newly initiating inebilizumab treatment at the discretion of their treating physician will have hematology, chemistry, B-cell count, serum immunoglobulin (Ig) levels, adverse events, concomitant medications list, NMOSD attacks information, antidrug antibody (ADA) status and titers collected.

Trial Locations (11)

6725

Szegedi Tudományegyetem, à OK, Szent-Györgyi Albert Klinikai Központ - Neurológiai Osztály, Szeged

10408

National Cancer Center - Neurology Clinic, Goyang-si

40002

Khon Kaen University, Srinagarind Hospital - Division of Neurology, Depart, Khon Kaen

48201-2153

Wayne State University School of Medicine, Detroit

77030-4202

Baylor College of Medicine, Houston

0000

Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology, Hong Kong

128 21

Vseobecna fakultni nemocnice v Praze - Neurologicka klinika, Prague

02-057

Uniwersyteckie Centrum Kliniczne WUM - Oddzial Kliniczny Neurologii, Warsaw

40-751

M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM, Katowice

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center - Pediatric Neurology, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY