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

Description

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.

Trial Eligibility

Inclusion Criteria: * Age ≥18 years at time of ICF signature. * Serum hs-CRP level ≥2.0 mg/L and \<15 mg/L * Diagnosis of chronic kidney disease, eGFR ≥15 and \<60 mL/min/1.73 m2 or eGFR ≥60 mL/min/1.73m2 and UPCR\>200 mg/g * Received COVID-19 vaccine at least 30 days prior to the Screening visit, per participant verbal attestation. * Agreement to comply with contraception and reproduction restrictions Exclusion Criteria: * Clinical evidence or suspicion of active infection * Current or recent COVID-19 infection within 30 days * Serious infection within 6 months or more than 1 such episode within 18 months * Any history of a serious opportunistic infection within 18 months * Known history of immunodeficiency * History of gastrointestinal ulceration or perforation within 12 months * History of active diverticulitis, active inflammatory bowel disease, or GI abscess within 12 months * History of GI bleeding requiring hospitalization and/or transfusion within 6 months * New York Heart Association Class III or IV congestive heart failure and/or hospitalization for heart failure exacerbation within 6 months * Acute coronary syndrome, stroke, transient ischemic attack, or other thrombotic or thromboembolic event, or arterial revascularization procedure within 6 months

Study Info

Interventions

Locations Recruiting

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