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A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
Sponsor: Tourmaline Bio, Inc., a Novartis Company
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
143
Start Date
2024-05-15
Completion Date
2025-12-04
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
TOUR006 - 50 MG
TOUR006 50 MG
TOUR006 - 25 MG
TOUR006 25 MG
TOUR006 - 15 MG
TOUR006 15 MG
Placebo
Placebo
Locations (38)
Site - 0101
Birmingham, Alabama, United States
Site - 0135
Huntsville, Alabama, United States
Site - 0145
Huntsville, Alabama, United States
Site - 0104
Phoenix, Arizona, United States
Site - 0125
San Dimas, California, United States
Site - 0112
Valencia, California, United States
Site - 0128
Valencia, California, United States
Site - 0136
Stamford, Connecticut, United States
Site - 0113
Greenacres City, Florida, United States
Site - 0149
Pembroke Pines, Florida, United States
Site - 0144
Plantation, Florida, United States
Site - 0119
Port Orange, Florida, United States
Site - 0151
Tampa, Florida, United States
Site - 0122
Savannah, Georgia, United States
Site - 0106
Chicago, Illinois, United States
Site - 0115
Morton, Illinois, United States
Site - 0114
Council Bluffs, Iowa, United States
Site - 0129
Metairie, Louisiana, United States
Site - 0123
Las Vegas, Nevada, United States
Site - 0130
Middletown, New York, United States
Site - 0110
Charlotte, North Carolina, United States
Site - 0117
Fargo, North Dakota, United States
Site - 0120
Cincinnati, Ohio, United States
Site - 0127
Marion, Ohio, United States
Site - 0132
Bethlehem, Pennsylvania, United States
Site - 0126
Providence, Rhode Island, United States
Site - 0102
Fort Mill, South Carolina, United States
Site - 0103
Greenville, South Carolina, United States
Site - 0108
Knoxville, Tennessee, United States
Site - 0148
Greenville, Texas, United States
Site - 0105
Houston, Texas, United States
Site - 0111
Lampasas, Texas, United States
Site - 0150
McKinney, Texas, United States
Site - 0107
San Antonio, Texas, United States
Site - 0141
San Antonio, Texas, United States
Site - 0109
Manassas, Virginia, United States
Site - 0147
Morgantown, West Virginia, United States
Site - 0134
Kenosha, Wisconsin, United States