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

• Status: Not yet recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nihon Pharmaceutical Co., Ltd
• Treatments: gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rho(D) Immune Globulin

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 physician.

• < 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 > atients 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 or subinvestigator

• < 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

• < At 2nd registration > Patients who meet any of the exclusion criteria at the time of first registration