Phase III Clinical Study of NPB-01 in Patients With Autoimmune Encephalitis
NCT05177939 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2022-12-01
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
Interventions
- DRUG
-
NPB-01
NPB-01 will be administered for the treatment of autoimmune encephalitis
- DRUG
-
NPB-01-ME
NPB-01-ME will be administered for the treatment of autoimmune encephalitis
Sponsors & Collaborators
-
Nihon Pharmaceutical Co., Ltd
lead INDUSTRY
Principal Investigators
-
Mamoru Ota · Nihon Pharmaceutical Co., Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-03
- Primary Completion
- 2024-05-31
- Completion
- 2024-10-31
Countries
- Japan
Study Locations
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