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The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.
This is a phase Ib/III study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg dose level, Phase III study is a multi-center, randomized, double-blind, positive control study to evaluate the safety and efficacy of IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-002 | Experimental | intravenous injection of 0.8mg/kg、1.2mg/kg |
|
| mycophenolate mofetil, MMF | Active Comparator | mycophenolate mofetil will be administrated as monotherapy control for 0.2g daily oral. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-002 | Drug | intravenous injection: Weekly administered for a period of first 4 weeks, then rest for 20 weeks. After the administration of the testing drug, if the subject's symptoms get worsen, a rescue therapy need to be adopted as based on Investigator's judgement, the testing drug injection should be discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of relapse-free patients | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first relapse (TFR) | Up to Week 24 | |
| Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study | The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments. Higher results represent higher levels of disability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jinhua zhou | Contact | 02138016387 | jinhua.zhou@immuneonco.com |
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| 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 |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| mycophenolate mofetil, MMF | Drug | daily oral 0.2g |
|
| Baseline (Day -28 to Day -1) to Week 24 |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |