A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP (TRANQUILITY)

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Status and phase: Enrolling; Phase 2

Conditions: Kidney Insufficiency, Chronic; Chronic Kidney Diseases; Hs-CRP; hsCRP; C-Reactive Protein; Chronic Renal Diseases; Chronic Renal Insufficiency; High Sensitivity C-Reactive Protein; Chronic Kidney Insufficiency

Treatments: Drug: TOUR006 - 25 MG; Drug: TOUR006 - 50 MG; Other: Placebo; Drug: TOUR006 - 15 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT06362759

TOUR006-C01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

TOUR006 - 50 MG

Experimental group

Description:

50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)

Treatment:

Drug: TOUR006 - 50 MG

TOUR006 - 25 MG

Experimental group

Description:

25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)

Treatment:

Drug: TOUR006 - 25 MG

TOUR006 - 15 MG

Experimental group

Description:

15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150

Treatment:

Drug: TOUR006 - 15 MG

Placebo

Placebo Comparator group

Description:

Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150

Treatment:

Other: Placebo