Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 4:34 PM
Study NCT ID:
NCT05796206
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Clinical Study of MIL62 in Systemic Lupus Erythematosus
Sponsor:
Beijing Mabworks Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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 study will evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.
Detailed Description:
None
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?: