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To compare the efficacy and safety of NPB-01 in patients with autoimmune encephalitis refractory to steroid pulse therapy using steroid pulse therapy as a control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPB-01 | Experimental | Intravenous immunoglobulin |
|
| NPB-01-ME | Active Comparator | methylprednisolone sodium succinate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPB-01 | Drug | NPB-01 will be administered for the treatment of autoimmune encephalitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders in CASE (Clinical Assessment Scale in Autoimmune Encephalitis) | A responder is defined as a patient whose CASE score at Week 4 of the post-treatment follow-up period after treatment with investigational product improved by 40% or more compared to the pre-treatment period. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CASE | The change in CASE score at each time point after the start of treatment with investigational product compared with that on Day 8 of the pretreatment period will be compared between the arms. Changes in CASE scores divided into three segments (0 -4: excellent, 5 -9: moderate, 10 -27: poor) will also be compared. In addition, the period until CASE score becomes 4 points or less after the start of treatment with investigational product will be checked. |
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Inclusion Criteria
< At 1st registration > Patients meeting the possible diagnostic criteria for autoimmune encephalitis
< At 1st registration > Patients with a CASE score of 5 to 22 during the screening period
< At 1st registration > Patients with autoimmune encephalitis in progress (active and requiring therapeutic intervention)
< At 1st registration > IVIG therapy and steroid pulse therapy are considered necessary by the investigator.
< At 1st registration > Patients aged 15 years or older at the time of informed consent
< At 2nd registration > Patients who meet any of the following (1) to (6):
< At 2nd registration > CASE score of 5 to 22 on Day 8 of the previous treatment period
< At 2nd registration > Patients who have had an inadequate response to steroid pulse therapy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mamoru Ota | Contact | 03-5148-7574 | kaihatsu@nihon-pharm.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Mamoru Ota | Nihon Pharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trial site 1 | Recruiting | Ube | Yamaguchi | Japan |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 30, 2025 | |
| Reset | Aug 18, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 30, 2025 | Aug 18, 2025 |
| ID | Term |
|---|---|
| D020274 | Autoimmune Diseases of the Nervous System |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| NPB-01-ME | Drug | NPB-01-ME will be administered for the treatment of autoimmune encephalitis |
|
|
| 1, 2, 3, 4, 6, 8, 12 weeks |
| mRS | Changes in mRS at each time point after the start of investigational product treatment compared with Day 8 of the pretreatment period will be compared between the arms. | 1, 2, 3, 4, 6, 8, 12 weeks |
| GCS | To compare the change in GCS at each time point after the start of investigational product with that on Day 8 of the pretreatment period between the arms. | 1, 2, 3, 4, 6, 8, 12 weeks |
| MMSE-J | The change in MMSE-J at each time point after the start of investigational product as compared with Day 8 of the pretreatment period will be compared between the arms. | 4, 8, 12 weeks |
| FAB | The change in FAB at each time point after the start of investigational product as compared with Day 8 of the pretreatment period will be compared between the arms. | 4, 8, 12 weeks |
| Disappearance of abnormal EEG findings | The proportion of subjects in whom abnormal findings in EEG disappeared at each time point after the start of investigational product as compared with Day 8 of the pretreatment period will be compared between the arms. | 4, 12 weeks |
| Disappearance of abnormal head MRI findings | The proportion of subjects in whom abnormal findings in head MRI disappeared at each time point after the start of investigational product as compared with Day 8 of the pretreatment period will be compared between the arms. | 4, 12 weeks |
| Cerebrospinal fluid test | The proportion of subjects in whom the cell count returned to within the reference range (≤ 5/μl) and the proportion of subjects in whom the protein count returned to within the reference range (15.0 ~ 45.0 mg/dL) at each time point after the start of investigational product treatment as compared with Day 8 of the pretreatment period will be checked. | 4, 12 weeks |
| Duration of hospitalization | Duration of hospitalization after the start of treatment with investigational product to be compared between the arms. | 12 weeks |
| mRS proportion | The proportions of subjects with an mRS score of ≤ 2, subjects with an improvement of ≥ 1 point, and subjects with an improvement of ≥ 2 points will also be compared. Also, the time to mRS improvement after the start of treatment with investigational product (≤ 2 points, ≥ 1 point improvement, ≥ 2 points improvement) . | 1, 2, 3, 4, 6, 8, 12 weeks |
| GCS proportion | Changes in GCS when divided into three segments (15-13: Mild, 12-9: Moderate, 8-3: Severe) will also be compared. In addition, the period until the GCS score reaches 13 or higher after the start of treatment with investigational product will be checked. | 1, 2, 3, 4, 6, 8, 12 weeks |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |