Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557174
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder NMOSD Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IbIII Multi-center Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder NMOSD Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD
Detailed Description:
This is a phase IbIII study including 2 stage phase Ib study to find the dose for phase II study between 08mgkg12mgkg dose level Phase III study is a multi-center randomized double-blind positive control study to evaluate the safety and efficacy of IMC-002 in Neuromyelitis Optica Spectrum Disorder NMOSD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None