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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
143
TOUR006 50 MG
TOUR006 25 MG
TOUR006 15 MG
Placebo
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
Evaluate the effects of TOUR006 compared with placebo on hs-CRP
Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo
Time frame: 90 days
Evaluate the effects of TOUR006 compared with placebo on hs-CRP
Percent of participants achieving hs-CRP less than 2 mg/L
Time frame: 90 days
Evaluate the effects of TOUR006 compared with placebo on hs-CRP
Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo
Time frame: 180 days
Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006
Evaluates the serum concentrations of TOUR006 over time
Time frame: Baseline through Day 365
Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD
Evaluates the percentage of participants with treatment emergent adverse events and serious adverse events
Time frame: 365 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 28 more locations