Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy
Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy
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.
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:
kaihatsu@nihon-pharm.co.jp03-5148-7574