Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362759
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-03-27
Brief Title:
A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
Sponsor:
Tourmaline Bio Inc
Organization:
Tourmaline Bio Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Study to Evaluate Quarterly and Monthly TOUR006 in Participants With Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein
Status:
RECRUITING
Status Verified Date:
2024-10
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:
TRANQUILITY
Brief Summary:
This study will evaluate the safety tolerability pharmacokinetics and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 also known as pacibekitug in participants with chronic kidney disease and elevated hs-CRP
Detailed Description:
Previous clinical studies have suggested that IL-6-driven inflammation plays a key role in the pathogenesis of cardiovascular diseases including atherosclerotic cardiovascular disease ASCVD and heart failure This Phase 2 study will evaluate the safety tolerability pharmacokinetics and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 a fully human monoclonal antibody against IL-6 TOUR006 binds the IL-6 cytokine and inhibits downstream IL-6 signaling thereby reducing the pharmacodynamic marker hs-CRP
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