Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-01 @ 10:55 AM
Study NCT ID:
NCT06647069
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2024-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DR-0201 in Subjects With Autoimmune Diseases
Sponsor:
Dren Bio
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Multiple Ascending Dose Basket Study to Evaluate the Safety and Activity of DR-0201 in Patients With Select Autoimmune Rheumatic Diseases
Status:
RECRUITING
Status Verified Date:
2025-11
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 multi-center, open-label, multi-ascending dose study to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical response of DR-0201 following IV administration in subjects with SLE, CLE, pSS, PM/DM, and/or dcSSc.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: