Phase III Clinical Study of NPB-01 in Patients With Autoimmune Encephalitis

NCT ID: NCT05177939

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2024-10-31

Brief Summary

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.

Conditions

Autoimmune Encephalitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NPB-01

Intravenous immunoglobulin

Group Type: EXPERIMENTAL

NPB-01

Intervention Type: DRUG

NPB-01 will be administered for the treatment of autoimmune encephalitis

NPB-01-ME

methylprednisolone sodium succinate

Group Type: ACTIVE_COMPARATOR

NPB-01-ME

Intervention Type: DRUG

NPB-01-ME will be administered for the treatment of autoimmune encephalitis

Interventions

NPB-01

NPB-01 will be administered for the treatment of autoimmune encephalitis

Intervention Type: DRUG

NPB-01-ME

NPB-01-ME will be administered for the treatment of autoimmune encephalitis

Intervention Type: DRUG

Other Intervention Names

Intravenous immunoglobulin; methylprednisolone sodium succinate

Eligibility Criteria

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):

1. Definite diagnostic criteria for autoimmune limbic encephalitis

2. MRI evidence of demyelination (probable autoimmune encephalitis)

3. Probabilistic diagnostic criteria for anti-NMDAR encephalitis

4. Probabilistic diagnostic criteria for Bickerstaff brainstem encephalitis

5. Probabilistic diagnostic criteria for Hashimoto's encephalopathy

6. Diagnostic Criteria for Autoimmune Encephalitis with Negative but Probable Autoantibodies

• < 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

• < At 1st registration > Patients with strongly suspected infectious encephalitis
• < At 1st registration > Patients who received immunoglobulin preparations within 8 weeks prior to informed consent
• < At 1st registration > Patients who received plasma exchange within 4 weeks prior to informed consent
• < At 1st registration > Patients who received immunosuppressants (Rituximab, cyclophosphamide, etc.) within 4 weeks prior to informed consent
• < At 1st registration > Patients who have had tumor resection associated with autoimmune encephalitis within 4 weeks prior to informed consent
• < At 1st registration > Patients with a history of shock or hypersensitivity to the ingredients of NPB-01
• < At 1st registration > Patients with known IgA deficiency
• < At 1st registration > Patients with renal disorder
• < At 1st registration > Patients with a current or previous history of cerebral or cardiovascular disorders (Asymptomatic cerebral infarction and myocardial infarction that occurred more than 5 years ago are not applicable.)
• < At 1st registration > Patients at high risk of thromboembolism
• < At 1st registration > Patients with haemolytic/blood loss anaemia
• < At 1st registration > Immunosuppressed/immunocompromised patients
• < At 1st registration > Patients with decreased cardiac function
• < At 1st registration > Pregnant, expected (desired or planned) pregnant, or breastfeeding patients
• < At 1st registration > Use of prohibited medications or treatment in this study
• < At 1st registration > Patients who received investigational product in this study (re-enrollment prohibited)
• < At 1st registration > Patients who have received treatment with investigational product other than this study within 4 months prior to informed consent
• < At 1st registration > Patients with a history of hypersensitivity to methylprednisolone sodium succinate
• < At 1st registration > Patients who have a tumor associated with autoimmune encephalitis and are considered to require resection during the study period.
• < At 1st registration > Patients receiving intravenous general anesthetics or sedative hypnotics
• < At 1st registration > Patients in coma
• < At 1st registration > Ventilated patients
• < At 1st registration > Patients who cannot undergo protocol-specified tests/assessments
• < At 1st registration > Other patients considered ineligible for the study by the investigator
• < At 2nd registration > Positive herpes simplex virus DNA qualitative test in the screening period.
• < At 2nd registration > Serum creatinine ≥ 2 times the upper limit of normal during the screening period.
• < At 2nd registration > Total protein ≥ 9 g/dL during the screening period.
• < At 2nd registration > Patients with hematocrit ≥ 55% during the screening period

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nihon Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mamoru Ota

Role: STUDY_CHAIR

Nihon Pharmaceutical Co., Ltd

Locations

Trial site 1

Ube, Yamaguchi, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Mamoru Ota

Role: CONTACT

kaihatsu@nihon-pharm.co.jp

03-5148-7574

Other Identifiers

NPB-01-19/C-01

Identifier Type: -

Identifier Source: org_study_id