A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

August 18, 2022

Primary Completion Date

February 21, 2025

Study Completion Date

March 31, 2027

Conditions
Neuromyelitis Optica Spectrum Disorder
Interventions
DRUG

MIL62

"Phase 1b: Participants will receive intravenous (IV) infusions of MIL62 at doses of 500 mg or 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, W79D1, W105D1, W131D1, W157D1, W183D1, and W209D1. Participants initially assigned to the 500 mg dose group who exhibit good tolerance may be escalated to the 1000 mg dose starting from W25D1.~Phase 3 (Randomised Controlled Period \[RCP\]): Participants will receive IV MIL62 1000 mg or placebo matched to MIL62 on W1D1, W3D1, W25D1, and W27D1. The administration protocol for placebo is identical to that of MIL62.~Phase 3 (Open-Label Period \[OLP\]): Participants who enter the OLP will receive IV MIL62 1000 mg on W1D1, W27D1, W53D1, W79D1, W105D1, and W131D1, along with matching placebo on W3D1."

OTHER

Placebo

"Phase 3 (RCP): Participants will receive IV placebo matched to MIL62 on W1D1, W3D1, W25D1, and W27D1.~Phase 3 (OLP): Participants entering the OLP will receive IV MIL62 1000 mg on W1D1, W3D1, W27D1, W53D1, W79D1, W105D1, and W131D1."

Trial Locations (1)

Unknown

Ethics Committee of Chinese PLA General Hosptial, Beijing

All Listed Sponsors
lead

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY