Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06127043
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-11-07
Brief Title:
A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis ROSETTA
Sponsor:
AnaptysBio Inc
Organization:
AnaptysBio Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ROSETTA STUDY This study will evaluate the safety tolerability and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis UC
Detailed Description:
This is a Phase 2 randomized double-blind placebo-controlled parallel-group multicenter study to evaluate the efficacy safety tolerability pharmacokinetics PK pharmacodynamics PD and immunogenicity of rosnilimab in subjects with moderate to severe ulcerative colitis UC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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