Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06044350
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-07-31
Brief Title:
A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
Sponsor:
Bio-Thera Solutions
Organization:
Bio-Thera Solutions
Study Overview
Official Title:
A Phase IIIII Study to Evaluate the Efficacy and Safety of BAT4406F Injection in Patients With Neuromyelitis Optica Lineage Disease
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase IIIII multicenter randomized double-blind placebo-controlled study to investigate the efficacy and safety of BAT4406F injection in patients with neuromyelitis optica lineage disease NMOSD who are positive for aquaporin 4 antibody AQP4-IgG
Detailed Description:
This study was a phase IIIII multicenter randomized double-blind placebo-controlled study which was divided into screening period 4 weeks randomized control period RCP and open-label period OlpA total of 162 subjects were enrolled during the screening period and randomly assigned 21 to either the BAT4406F group or the placebo group after randomization on Day 1 of the RCP subjects would receive BAT4406F at a dose of 500mg or placebo intravenously at D 1 and D 182 respectively
If any of the following conditions occur subjects can enter OLP from RCP 1 Subjects who complete the 52-week RCP study without recurrence of NMOSD can enter Olp within 14 days after the end of the RCP study 2 In the stage of RCP NMOSD recurred After rescue therapy the patients with stable condition could enter OLP within 28 days after diagnosis Subjects continued to participate in the RCP study if they were not identified by CEC as having a relapse upon examination 3 When a protocol-defined first relapse event of 35 cases is observed or when all 162 subjects have completed randomization and 12 months have elapsed since the first dose in the last of these subjects or when recommended by the Independent Data Monitoring Committee IDMC the RCP study should be stopped for enrolled subjects and all enrolled subjects at the RCP stage should stop the RCP study within 14 days of entry into OLP after which subjects will receive BAT4406F injection at the same dose as RCP at d 1 of OLP After termination of the RCP study with BAT4406F every 6 months subjects were given the option of enrolling in the OLP study
If any of the following conditions occur subjects can enter OLP from RCP 1 Subjects who complete the 52-week RCP study without recurrence of NMOSD can enter Olp within 14 days after the end of the RCP study 2 In the stage of RCP NMOSD recurred After rescue therapy the patients with stable condition could enter OLP within 28 days after diagnosis Subjects continued to participate in the RCP study if they were not identified by CEC as having a relapse upon examination 3 When a protocol-defined first relapse event of 35 cases is observed or when all 162 subjects have completed randomization and 12 months have elapsed since the first dose in the last of these subjects or when recommended by the Independent Data Monitoring Committee IDMC the RCP study should be stopped for enrolled subjects and all enrolled subjects at the RCP stage should stop the RCP study within 14 days of entry into OLP after which subjects will receive BAT4406F injection at the same dose as RCP at d 1 of OLP After termination of the RCP study with BAT4406F every 6 months subjects were given the option of enrolling in the OLP study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None