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

NCT06362759 | Completed Phase 2 FDA Drug

• 1 other identifier: TOUR006-C01
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 38

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.

Conditions

Chronic Kidney Diseases; C-Reactive Protein; Chronic Kidney Insufficiency; Chronic Renal Diseases; Chronic Renal Insufficiency; Kidney Insufficiency, Chronic; High Sensitivity C-Reactive Protein; hsCRP

Keywords

Interleukin-6; IL-6; IL6; Interleukin-6 Inhibitors; Anti-interleukin-6 Agents; Anti-inflammatory Agents; Antiinflammatory Agent; Antiinflammatory Agents; Agents, Antiinflammatory; Anti-inflammatory Agent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluate the effects of TOUR006 compared with placebo on hs-CRP

  90 days

• Evaluate the effects of TOUR006 compared with placebo on hs-CRP

  180 days

• Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006

  Baseline through Day 365

• Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD

  365 days

Study Arms (4)

TOUR006 - 50 MG

EXPERIMENTAL

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

Drug: TOUR006 - 50 MG

TOUR006 - 25 MG

EXPERIMENTAL

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

Drug: TOUR006 - 25 MG

TOUR006 - 15 MG

EXPERIMENTAL

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

Drug: TOUR006 - 15 MG

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

TOUR006 - 50 MG DRUG

TOUR006 50 MG

Also known as: Pacibekitug 50 MG

TOUR006 - 50 MG

TOUR006 - 25 MG DRUG

TOUR006 25 MG

Also known as: Pacibekitug 25 MG

TOUR006 - 25 MG

TOUR006 - 15 MG DRUG

TOUR006 15 MG

Also known as: Pacibekitug 15 MG

TOUR006 - 15 MG

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tourmaline Bio, Inc.: lead

Study Sites (38)

Site - 0101

Birmingham, Alabama, 35209, United States

Location

Site - 0135

Huntsville, Alabama, 35763, United States

Location

Site - 0145

Huntsville, Alabama, 35805, United States

Location

Site - 0104

Phoenix, Arizona, 85018, United States

Location

Site - 0125

San Dimas, California, 91773, United States

Location

Site - 0112

Valencia, California, 91355, United States

Location

Site - 0128

Valencia, California, 91355, United States

Location

Site - 0136

Stamford, Connecticut, 06905, United States

Location

Site - 0113

Greenacres City, Florida, 334667, United States

Location

Site - 0149

Pembroke Pines, Florida, 33024, United States

Location

Site - 0144

Plantation, Florida, 33317, United States

Location

Site - 0119

Port Orange, Florida, 32127, United States

Location

Site - 0151

Tampa, Florida, 33634, United States

Location

Site - 0122

Savannah, Georgia, 31406, United States

Location

Site - 0106

Chicago, Illinois, 60655, United States

Location

Site - 0115

Morton, Illinois, 61550, United States

Location

Site - 0114

Council Bluffs, Iowa, 51501, United States

Location

Site - 0129

Metairie, Louisiana, 70006, United States

Location

Site - 0123

Las Vegas, Nevada, 89121, United States

Location

Site - 0130

Middletown, New York, 10940, United States

Location

Site - 0110

Charlotte, North Carolina, 28208, United States

Location

Site - 0117

Fargo, North Dakota, 58104, United States

Location

Site - 0120

Cincinnati, Ohio, 45219, United States

Location

Site - 0127

Marion, Ohio, 43302, United States

Location

Site - 0132

Bethlehem, Pennsylvania, 18017, United States

Location

Site - 0126

Providence, Rhode Island, 02818, United States

Location

Site - 0102

Fort Mill, South Carolina, 29707, United States

Location

Site - 0103

Greenville, South Carolina, 29607, United States

Location

Site - 0108

Knoxville, Tennessee, 37923, United States

Location

Site - 0148

Greenville, Texas, 75402, United States

Location

Site - 0105

Houston, Texas, 77043, United States

Location

Site - 0111

Lampasas, Texas, 76550, United States

Location

Site - 0150

McKinney, Texas, 75069, United States

Location

Site - 0107

San Antonio, Texas, 78212, United States

Location

Site - 0141

San Antonio, Texas, 78255, United States

Location

Site - 0109

Manassas, Virginia, 20110, United States

Location

Site - 0147

Morgantown, West Virginia, 26505, United States

Location

Site - 0134

Kenosha, Wisconsin, 53144, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Tourmaline Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 12, 2024
• Study Start: May 15, 2024
• Primary Completion: March 6, 2025
• Study Completion: December 4, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (38)