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

Phase 2

Active, not recruiting

• Conditions: Hs-CRP; Chronic Renal Diseases; High Sensitivity C-Reactive Protein; Chronic Kidney Diseases; Chronic Kidney Insufficiency; C-Reactive Protein; Kidney Insufficiency, Chronic; hsCRP; Chronic Renal Insufficiency
• Interventions: Drug: TOUR006 - 15 MG; Drug: TOUR006 - 25 MG; Other: Placebo; Drug: TOUR006 - 50 MG

• Registration Number: NCT06362759
• Lead Sponsor: Tourmaline Bio, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Study Start: 2024-05-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 143

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOUR006 - 15 MG	TOUR006 - 15 MG	15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 25 MG	TOUR006 - 25 MG	25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
Placebo	Placebo	Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
TOUR006 - 50 MG	TOUR006 - 50 MG	50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)

Primary Outcome Measures

Name	Time	Method
Evaluate the effects of TOUR006 compared with placebo on hs-CRP	90 days	Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo

Secondary Outcome Measures

Name	Time	Method
Evaluate the effects of TOUR006 compared with placebo on hs-CRP	180 days	Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo
Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD	365 days	Evaluates the percentage of participants with treatment emergent adverse events and serious adverse events
Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006	Baseline through Day 365	Evaluates the serum concentrations of TOUR006 over time

Trial Locations

Locations (49)

Site - 0124; 🇺🇸 Birmingham, Alabama, United States

Site - 0101; 🇺🇸 Birmingham, Alabama, United States

Site - 0135; 🇺🇸 Huntsville, Alabama, United States

Site - 0145; 🇺🇸 Huntsville, Alabama, United States

Site - 0104; 🇺🇸 Phoenix, Arizona, United States

Site - 0125; 🇺🇸 San Dimas, California, United States

Site - 0112; 🇺🇸 Valencia, California, United States

Site - 0128; 🇺🇸 Valencia, California, United States

Site - 0136; 🇺🇸 Stamford, Connecticut, United States

Site - 0142; 🇺🇸 Boca Raton, Florida, United States

Site - 0113; 🇺🇸 Greenacres City, Florida, United States

Site - 0149; 🇺🇸 Pembroke Pines, Florida, United States

Site - 0144; 🇺🇸 Plantation, Florida, United States

Site - 0119; 🇺🇸 Port Orange, Florida, United States

Site - 0151; 🇺🇸 Tampa, Florida, United States

Site - 0122; 🇺🇸 Savannah, Georgia, United States

Site - 0139; 🇺🇸 Boise, Idaho, United States

Site - 0106; 🇺🇸 Chicago, Illinois, United States

Site - 0115; 🇺🇸 Morton, Illinois, United States

Site - 0133; 🇺🇸 Park Ridge, Illinois, United States

Site - 0114; 🇺🇸 Council Bluffs, Iowa, United States

Site - 0129; 🇺🇸 Metairie, Louisiana, United States

Site - 0140; 🇺🇸 Saint Clair Shores, Michigan, United States

Site - 0123; 🇺🇸 Las Vegas, Nevada, United States

Site - 0130; 🇺🇸 Middletown, New York, United States

Site - 0110; 🇺🇸 Charlotte, North Carolina, United States

Site - 0117; 🇺🇸 Fargo, North Dakota, United States

Site - 0120; 🇺🇸 Cincinnati, Ohio, United States

Site - 0127; 🇺🇸 Marion, Ohio, United States

Site - 0132; 🇺🇸 Bethlehem, Pennsylvania, United States

Site - 0138; 🇺🇸 Scottdale, Pennsylvania, United States

Site - 0126; 🇺🇸 Providence, Rhode Island, United States

Site - 0102; 🇺🇸 Fort Mill, South Carolina, United States

Site - 0103; 🇺🇸 Greenville, South Carolina, United States

Site - 0118; 🇺🇸 Rock Hill, South Carolina, United States

Site - 0116; 🇺🇸 Rapid City, South Dakota, United States

Site - 0143; 🇺🇸 Knoxville, Tennessee, United States

Site - 0108; 🇺🇸 Knoxville, Tennessee, United States

Site - 0148; 🇺🇸 Greenville, Texas, United States

Site - 0105; 🇺🇸 Houston, Texas, United States

Site - 0111; 🇺🇸 Lampasas, Texas, United States

Site - 0150; 🇺🇸 McKinney, Texas, United States

Site - 0107; 🇺🇸 San Antonio, Texas, United States

Site - 0141; 🇺🇸 San Antonio, Texas, United States

Site - 0109; 🇺🇸 Manassas, Virginia, United States

Site - 0137; 🇺🇸 Kingwood, West Virginia, United States

Site - 0147; 🇺🇸 Morgantown, West Virginia, United States

Site - 0134; 🇺🇸 Kenosha, Wisconsin, United States

Site - 0121; 🇺🇸 Wauwatosa, Wisconsin, United States