A Study to Evaluate TOUR006 in Patients With Chronic Kidn... | NCT06362759

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

NCT06362759

Sponsor

Tourmaline Bio, Inc., a Novartis Company

Status

Completed

Last Update Posted

Feb 24, 2026Actual

Enrollment

143Actual

Phase

Phase 2

Conditions

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

Interventions

TOUR006 - 50 MG
TOUR006 - 25 MG
TOUR006 - 15 MG
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2024Actual

Primary Completion Date

Mar 6, 2025Actual

Completion Date

Dec 4, 2025Actual

First Submitted Date

Mar 27, 2024

First Submission Date that Met QC Criteria

Apr 8, 2024

First Posted Date

Apr 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 20, 2026

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Feb 23, 2026Actual

Last Update Submitted Date

Feb 20, 2026

Last Update Posted Date

Feb 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Chronic Kidney Diseases
Chronic Kidney Insufficiency
Chronic Renal Diseases
Chronic Renal Insufficiency
Kidney Insufficiency, Chronic
C-Reactive Protein
High Sensitivity C-Reactive Protein
Hs-CRP
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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
TOUR006 - 50 MG	Drug	TOUR006 50 MG	TOUR006 - 50 MG	Pacibekitug 50 MG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Evaluate the effects of TOUR006 compared with placebo on hs-CRP	Percent of participants achieving hs-CRP less than 2 mg/L	90 days
Evaluate the effects of TOUR006 compared with placebo on hs-CRP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Tourmaline Bio	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site - 0101		Birmingham	Alabama	35209	United States
Site - 0135

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms