NCT06362759

A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Tourmaline Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Diseases
• Chronic Kidney Insufficiency
• Chronic Renal Diseases
• Chronic Renal Insufficiency
• Kidney Insufficiency, Chronic
• C-Reactive Protein
• High Sensitivity C-Reactive Protein
• Hs-CRP
• hsCRP

Interventions

Type	Name	Description
DRUG	TOUR006 - 50 MG	TOUR006 50 MG
DRUG	TOUR006 - 25 MG	TOUR006 25 MG
DRUG	TOUR006 - 15 MG	TOUR006 15 MG
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-05-15
• Primary completion: 2025-03-06
• Completion: 2025-12-04
• First posted: 2024-04-12
• Last updated: 2026-02-24

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated drug study