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

April 8, 2024 updated by: Tourmaline Bio, Inc.

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 in participants with chronic kidney disease and elevated hs-CRP.

Study Overview

Status

Not yet recruiting

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 (Estimated)

120

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 Contact

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
  • 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

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
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
Experimental: TOUR006 - 15 MG
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Drug: TOUR006 - 15 MG
TOUR006 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
Evaluate the effects of TOUR006 compared with placebo on hs-CRP
Time Frame: 90 days
Evaluates the change from baseline in hs-CRP comparing TOUR006 and placebo
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Tourmaline Bio, Inc.

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

February 1, 2026

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)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

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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