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

TOUR006-C01

This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 in participants with chronic kidney disease and elevated hs-CRP.

2024-05-15

2025-05-01

2026-02-01

Recruiting

Early phase I

120

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 * 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 12 months * Any history of a serious opportunistic infection * Known history of immunodeficiency * History of gastrointestinal ulceration or perforation * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-05-21