TRANQUILITY
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Quarterly and Monthly TOUR006 (Pacibekitug) in Participants With Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein
Patient / Population Intervention / Exposure Comparison Outcome
In 143 patients with chronic kidney disease and raised hs-CRP, pacibekitug, an IL-6 antibody was compared with placebo on the change in hs-CRP through day 90.
N
143
Design
Phase 2 double-blind, placebo-controlled RCT, four parallel arms (placebo; 15 mg monthly; 25 mg quarterly; 50 mg quarterly), subcutaneous dosing on days 1–150, primary analysis through day 90
Endpoint
Time-averaged percentage change from baseline in hs-CRP through day 90