Chronic Kidney DiseasesPhase 2TRANQUILITYNCT06362759

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

A Phase 2 study testing TOUR006 - 50 MG, TOUR006 - 25 MG and TOUR006 - 15 MG in people with Chronic Kidney Diseases and Chronic Kidney Insufficiency, run by Tourmaline Bio, Inc., a Novartis Company at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Diseases, Chronic Kidney Insufficiency, Chronic Renal Diseases
What is being tested?: TOUR006 - 50 MG, TOUR006 - 25 MG and TOUR006 - 15 MG
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 143 participants
Where: 38 sitesUnited States
Study dates: 15 May 2024to 4 Dec 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

38 sites in 1 country.

City, postcode or hospital

38 sites in 1 country

United States38 sites

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

Other trials in United States

About this study

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

Read the 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: Chronic Kidney Diseases, Chronic Kidney Insufficiency, Chronic Renal Diseases, Chronic Renal Insufficiency, Kidney Insufficiency, Chronic, C-Reactive Protein
Being tested: TOUR006 - 50 MG, TOUR006 - 25 MG, TOUR006 - 15 MG, Placebo
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
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TOUR006 - 50 MGDrug
Also called Pacibekitug 50 MG
TOUR006 50 MG
TOUR006 - 25 MGDrug
Also called Pacibekitug 25 MG
TOUR006 25 MG
TOUR006 - 15 MGDrug
Also called Pacibekitug 15 MG
TOUR006 15 MG
PlaceboOther
Placebo

Study groups in NCT06362759
Study group	Role	What they receive
TOUR006 - 50 MG	Experimental	50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints) Receives: 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) Receives: Drug: TOUR006 - 25 MG
TOUR006 - 15 MG	Experimental	15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150 Receives: Drug: TOUR006 - 15 MG
Placebo	Placebo comparator	Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150 Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90
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.
Measured: Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.

Secondary outcomes (5)

Proportion of Participants With Time-averaged Hs-CRP < 2 mg/L (90 Days)
Proportion of participants with time-averaged hs-CRP < 2 mg/L (90 Days)
Measured: 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-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.
Measured: 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
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.
Measured: Baseline through Day 365
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 (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.
Measured: Baseline through Day 365.
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD
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.
Measured: Baseline through Day 365.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 20244 Dec 2025

First posted12 Apr 2024
Study start15 May 2024
Primary completion6 Mar 2025
Study completion4 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06362759
Sponsor's protocol ID: TOUR006-C01
Acronym: TRANQUILITY
Status last verified: Jul 2026
First submitted: 27 Mar 2024
Last updated: 11 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06362759
Acronym / sponsor ID: TRANQUILITY / TOUR006-C01
Conditions: Chronic Kidney Diseases, Chronic Kidney Insufficiency, Chronic Renal Diseases, Chronic Renal Insufficiency, Kidney Insufficiency, Chronic, C-Reactive Protein
Keywords: Interleukin-6, IL-6, IL6, Interleukin-6 Inhibitors, Anti-interleukin-6 Agents, Anti-inflammatory Agents, Antiinflammatory Agent, Antiinflammatory Agents
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Tourmaline Bio, Inc., a Novartis CompanyIndustry (pharma, biotech, devices)
Study start: 15 May 2024 (actual)
Primary completion: 6 Mar 2025 (actual)
Study completion: 4 Dec 2025 (actual)
First posted: 12 Apr 2024 (actual)
Results: Posted 11 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
TOUR006 - 50 MG	Experimental	Drug: TOUR006 - 50 MG50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 25 MG	Experimental	Drug: TOUR006 - 25 MG25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
TOUR006 - 15 MG	Experimental	Drug: TOUR006 - 15 MG15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Placebo	Placebo comparator	Other: PlaceboAdministered subcutaneously at Days 1, 30, 60, 90, 120, and 150

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TOUR006 - 50 MGAlso: Pacibekitug 50 MGTOUR006 50 MG	Drug	TOUR006 - 50 MG
TOUR006 - 25 MGAlso: Pacibekitug 25 MGTOUR006 25 MG	Drug	TOUR006 - 25 MG
TOUR006 - 15 MGAlso: Pacibekitug 15 MGTOUR006 15 MG	Drug	TOUR006 - 15 MG
PlaceboPlacebo	Other	Placebo

Primary outcome

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.

5 secondary outcomes

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.
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.
Evaluate the Pharmacokinetics by Measuring Serum Concentrations of TOUR006
Time frame: 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.
Evaluate the Safety and Tolerability of TOUR006 in Participants With Elevated Cardiovascular Risk and CKD
Time frame: Baseline through Day 365.

Results and safety

Results posted to the registry on 11 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	36	33
TOUR006 - 25 MG	35	33
TOUR006 - 50 MG	36	29
TOUR006 - 15 MG	36	32

Primary outcome: 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.. Median (Inter-Quartile Range). Unit: Time-Averaged Percent Change in hsCRP

Measure	Placebo n = 31	TOUR006 - 25 MG n = 31	TOUR006 - 50 MG n = 30	TOUR006 - 15 MG n = 34
Value	-14.8 (-35.8 to 17.4)	-75.2 (-82.3 to -69.7)	-85.7 (-92.3 to -78.0)	-84.7 (-92.3 to -70.3)

Placebo vs TOUR006 - 25 MG: Median Difference (Net): -59.817 (95% CI -79.690 to -39.943), p <0.0001, Quantile Regression
Placebo vs TOUR006 - 50 MG: Median Difference (Net): -70.155 (95% CI -90.188 to -50.122), p <0.0001, Quantile Regression
Placebo vs TOUR006 - 15 MG: Mean Difference (Net): -68.627 (95% CI -88.765 to -48.489), p <0.0001, Quantile Regression

Population analysed: Includes all randomized participants who received any amount of investigational product, had a baseline hs-CRP ≥1.9 mg/L, and did not miss more than one post-baseline hs-CRP assessment in the first 90 days of study. (modified-ITT)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through Day 365.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of 36 (16.7%)	22 of 36 (61.1%)	0 of 36
TOUR006 - 25 MG	7 of 35 (20%)	21 of 35 (60%)	1 of 35
TOUR006 - 50 MG	6 of 35 (17.1%)	21 of 35 (60%)	1 of 35
TOUR006 - 15 MG	3 of 35 (8.6%)	21 of 35 (60%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Tourmaline Bio

38 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06362759.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.