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

July 17, 2026 updated by: Tourmaline Bio, Inc., a Novartis Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Site - 0101
      • Huntsville, Alabama, United States, 35763
        • Site - 0135
      • Huntsville, Alabama, United States, 35805
        • Site - 0145
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Site - 0104
    • California
      • San Dimas, California, United States, 91773
        • Site - 0125
      • Valencia, California, United States, 91355
        • Site - 0112
      • Valencia, California, United States, 91355
        • Site - 0128
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Site - 0136
    • Florida
      • Greenacres City, Florida, United States, 334667
        • Site - 0113
      • Pembroke Pines, Florida, United States, 33024
        • Site - 0149
      • Plantation, Florida, United States, 33317
        • Site - 0144
      • Port Orange, Florida, United States, 32127
        • Site - 0119
      • Tampa, Florida, United States, 33634
        • Site - 0151
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Site - 0122
    • Illinois
      • Chicago, Illinois, United States, 60655
        • Site - 0106
      • Morton, Illinois, United States, 61550
        • Site - 0115
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • Site - 0114
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Site - 0129
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Site - 0123
    • New York
      • Middletown, New York, United States, 10940
        • Site - 0130
    • North Carolina
      • Charlotte, North Carolina, United States, 28208
        • Site - 0110
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Site - 0117
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Site - 0120
      • Marion, Ohio, United States, 43302
        • Site - 0127
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Site - 0132
    • Rhode Island
      • Providence, Rhode Island, United States, 02818
        • Site - 0126
    • South Carolina
      • Fort Mill, South Carolina, United States, 29707
        • Site - 0102
      • Greenville, South Carolina, United States, 29607
        • Site - 0103
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Site - 0108
    • Texas
      • Greenville, Texas, United States, 75402
        • Site - 0148
      • Houston, Texas, United States, 77043
        • Site - 0105
      • Lampasas, Texas, United States, 76550
        • Site - 0111
      • McKinney, Texas, United States, 75069
        • Site - 0150
      • San Antonio, Texas, United States, 78212
        • Site - 0107
      • San Antonio, Texas, United States, 78255
        • Site - 0141
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Site - 0109
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Site - 0147
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Site - 0134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TOUR006 - 50 MG
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 50 MG
Other Names:
  • Pacibekitug 50 MG
Experimental: TOUR006 - 25 MG
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 25 MG
Other Names:
  • Pacibekitug 25 MG
Experimental: TOUR006 - 15 MG
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Drug: TOUR006 - 15 MG
TOUR006 15 MG
Other Names:
  • Pacibekitug 15 MG
Placebo Comparator: Placebo
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90
Time Frame: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 90. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 90 visits (approximately 60 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.
Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Time-averaged Hs-CRP < 2 mg/L (90 Days)
Time Frame: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Proportion of participants with time-averaged hs-CRP < 2 mg/L (90 Days)
Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 180
Time Frame: Baseline through 180 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Time-averaged percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) through Day 180. The time-averaged percent change from baseline in hs-CRP is the area under the curve for percent change from baseline in hs-CRP divided by the number of days from the observed Day 30 to Day 180 visits (approximately 150 days if visits occur according to the protocol). The calculation uses the linear trapezoidal rule according to the observed visit days.
Baseline through 180 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Time Frame: Baseline through Day 365
Mean trough serum concentrations (ng/mL) of TOUR006 at Days 30, 60, 90,120, 150, 180, 240, 300, and 365. On dosing visits (BL and Day 30, 60, 90, 120, and 150 visits), PK samples were collected pre-dose. PK blood samples were collected on Study Days 180, 240, 300, and 365 at approximately the same time as the pre-dose samples were collected on previous dosing visits.
Baseline through Day 365
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD
Time Frame: Baseline through Day 365.
Evaluates the percentage of participants with treatment emergent adverse events (AE), which includes serious and nonserious AEs. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.
Baseline through Day 365.
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD
Time Frame: Baseline through Day 365.
Evaluates the percentage of participants with serious treatment emergent adverse events. Treatment-emergent is defined as AEs that initiated or worsened after receiving at least 1 dose of study drug and includes a total of 141 participants.
Baseline through Day 365.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tourmaline Bio, Inc., a Novartis Company

Investigators

  • Study Director: Clinical Trials, Tourmaline Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Actual)

March 6, 2025

Study Completion (Actual)

December 4, 2025

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOUR006-C01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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