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

TRANQUILITY

Paciente / Población Intervención / Exposición Comparación Desenlace

In 143 patients with chronic kidney disease and raised hs-CRP, pacibekitug, an IL-6 antibody reduced hs-CRP through day 90 compared with placebo.

N

143pacientes

Diseño

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

Desenlace

Time-averaged percentage change from baseline in hs-CRP through day 90

Relevancia

3Complementario — contexto, no conocimiento imprescindible.

ResultadoPrimary endpoint met: median time-averaged reduction in hs-CRP through day 90 was 75–86% across the three active arms vs 15% with placebo (P < 0.0001 for all comparisons). Time-averaged hs-CRP < 2 mg/L through day 90 in 80–88% of active-arm participants vs 26% on placebo. Adverse events 54% vs 56% placebo, serious adverse events 10% vs 11%, discontinuation for adverse events 1.9% vs 0; one death (COVID-19).

Bhatt DL, et al. TRANQUILITY (NCT06362759). Primary Day-90 results presented at ESC Congress 2025, 31 August 2025; Day-180 data presented at ESC Congress 2026 Hot Line, 29 August 2026. Not yet published.

Discusión y crítica

A phase 2 biomarker trial: 143 patients, six months, and an endpoint that is a blood test rather than an event. The hs-CRP reduction is large and holds on quarterly dosing, which is the practical point — an IL-6 antibody given four times a year. Whether lowering interleukin-6 signalling prevents cardiovascular events in chronic kidney disease is the question phase 3 has to answer; ZEUS and the ziltivekimab programme are the precedent, not the proof.