Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535412
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-center Randomized Double-blind Placebo Control Phase 1bII Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 active SLE
Detailed Description:
This is a phase IbII study including 2 stage phase Ib study to find the dose for phase II study between 08mgkg12mgkg and 16mgkg dose level Phase II study is a multi-center randomized double-blind placebo control study to evaluate the safety and efficacy of IMC-002 in active Systemic Lupus Erythematosus patients
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