Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIL62 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIL62 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: The incidence and severity of all adverse events (AE) | Up to Week 234 | |
| Phase 3: Time to First Adjudicated Relapse (TFR) during RCP. | The time from the date of randomization to the date of the first clinical relapse as assessed by the Clinical Endpoint Committee(CEC). The criteria for NMOSD relapse are the occurrence of new objective neurological symptoms or worsening of objective neurological symptoms; meeting any one of the relapse criteria specified in the protocol is sufficient. | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first adjudicated relapse | Up to Week 208 | |
| Annualized relapse rate | Up to Week 208 | |
| Change from baseline of Expanded Disability Status Scale (EDSS) score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ethics Committee of Chinese PLA General Hosptial | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42177718 | Derived | Wu L, Wei M, Gao F, Zhang H, Wang J, Xiang F, Gao S, Liu R, Yin J, Guo Y, Liu X, Liang J, Liu S, Li F, Huang D. Safety and Efficacy of Obinutuzumab beta (MIL62), a Novel Glycoengineered Type II Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorder: A Multicenter, Single-Arm, Phase Ib Clinical Trial. Neurol Ther. 2026 May 24. doi: 10.1007/s40120-026-00960-w. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | 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. |
|
| Up to Week 208 |
| Annualized cumulative active lesions rate on MRI | Up to Week 208 |
| Annualised NMOSD-related inpatient hospitalisation rate. | Up to Week 208 |
| Mean Change in T-score from Baseline in the EQ5D Scale. | Up to Week 208 |
| Percentage of Participants with Adverse Events (AEs). | Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 | Up to Week 208 |
| Peripheral B-cell Counts at Specified Timepoints. | Up to Week 208 |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |