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

Chronic Kidney Diseases Clinical Trial

— TRANQUILITY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362759
• Other study ID #: TOUR006-C01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2024
• Est. completion date: February 2026

Study information

• Verified date: June 2024
• Source: Tourmaline Bio, Inc.
• Contact: Tourmaline Bio
• Phone: 347-773-2627
• Email: clinicaltrialinquiries[@]tourmalinebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

• 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

Related Conditions & MeSH terms

• C-Reactive Protein
• Chronic Kidney Diseases
• Chronic Kidney Insufficiency
• Chronic Renal Diseases
• Chronic Renal Insufficiency
• hsCRP
• Hypersensitivity
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Insufficiency, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• TOUR006 - 50 MG
TOUR006 50 MG
• TOUR006 - 25 MG
TOUR006 25 MG
• TOUR006 - 15 MG
TOUR006 15 MG

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Site - 0101	Birmingham	Alabama
United States	Site - 0110	Charlotte	North Carolina
United States	Site - 0117	Fargo	North Dakota
United States	Site - 0102	Fort Mill	South Carolina
United States	Site - 0103	Greenville	South Carolina
United States	Site - 0105	Houston	Texas
United States	Site - 0108	Knoxville	Tennessee
United States	Site - 0111	Lampasas	Texas
United States	Site - 0123	Las Vegas	Nevada
United States	Site - 0109	Manassas	Virginia
United States	Site - 0127	Marion	Ohio
United States	Site - 0104	Phoenix	Arizona
United States	Site - 0116	Rapid City	South Dakota
United States	Site - 0107	San Antonio	Texas
United States	Site - 0125	San Dimas	California
United States	Site - 0121	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Tourmaline Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effects of TOUR006 compared with placebo on hs-CRP	Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo	90 days
Secondary	Evaluate the effects of TOUR006 compared with placebo on hs-CRP	Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo	180 days
Secondary	Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006	Evaluates the serum concentrations of TOUR006 over time	Baseline through Day 365
Secondary	Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD	Evaluates the percentage of participants with treatment emergent adverse events and serious adverse events	365 days