Clinical trial NCT06362759: A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: Tourmaline Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP
timeFrame: 90 days
Secondary outcomes:
measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP
timeFrame: 180 days
measure: Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006
timeFrame: Baseline through Day 365
measure: Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD
timeFrame: 365 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site - 0124
state: Alabama
city: Birmingham
country: United States
facility: Site - 0101
state: Alabama
city: Huntsville
country: United States
facility: Site - 0135
state: Alabama
city: Huntsville
country: United States
facility: Site - 0145
state: Alabama
city: Phoenix
country: United States
facility: Site - 0104
state: Arizona
city: San Dimas
country: United States
facility: Site - 0125
state: California
city: Valencia
country: United States
facility: Site - 0112
state: California
city: Valencia
country: United States
facility: Site - 0128
state: California
city: Stamford
country: United States
facility: Site - 0136
state: Connecticut
city: Boca Raton
country: United States
facility: Site - 0142
state: Florida
city: Greenacres City
country: United States
facility: Site - 0113
state: Florida
city: Pembroke Pines
country: United States
facility: Site - 0149
state: Florida
city: Plantation
country: United States
facility: Site - 0144
state: Florida
city: Port Orange
country: United States
facility: Site - 0119
state: Florida
city: Tampa
country: United States
facility: Site - 0151
state: Florida
city: Savannah
country: United States
facility: Site - 0122
state: Georgia
city: Boise
country: United States
facility: Site - 0139
state: Idaho
city: Chicago
country: United States
facility: Site - 0106
state: Illinois
city: Morton
country: United States
facility: Site - 0115
state: Illinois
city: Park Ridge
country: United States
facility: Site - 0133
state: Illinois
city: Council Bluffs
country: United States
facility: Site - 0114
state: Iowa
city: Metairie
country: United States
facility: Site - 0129
state: Louisiana
city: Saint Clair Shores
country: United States
facility: Site - 0140
state: Michigan
city: Las Vegas
country: United States
facility: Site - 0123
state: Nevada
city: Middletown
country: United States
facility: Site - 0130
state: New York
city: Charlotte
country: United States
facility: Site - 0110
state: North Carolina
city: Fargo
country: United States
facility: Site - 0117
state: North Dakota
city: Cincinnati
country: United States
facility: Site - 0120
state: Ohio
city: Marion
country: United States
facility: Site - 0127
state: Ohio
city: Bethlehem
country: United States
facility: Site - 0132
state: Pennsylvania
city: Scottdale
country: United States
facility: Site - 0138
state: Pennsylvania
city: Providence
country: United States
facility: Site - 0126
state: Rhode Island
city: Fort Mill
country: United States
facility: Site - 0102
state: South Carolina
city: Greenville
country: United States
facility: Site - 0103
state: South Carolina
city: Rock Hill
country: United States
facility: Site - 0118
state: South Carolina
city: Rapid City
country: United States
facility: Site - 0116
state: South Dakota
city: Knoxville
country: United States
facility: Site - 0143
state: Tennessee
city: Knoxville
country: United States
facility: Site - 0108
state: Tennessee
city: Greenville
country: United States
facility: Site - 0148
state: Texas
city: Houston
country: United States
facility: Site - 0105
state: Texas
city: Lampasas
country: United States
facility: Site - 0111
state: Texas
city: McKinney
country: United States
facility: Site - 0150
state: Texas
city: San Antonio
country: United States
facility: Site - 0107
state: Texas
city: San Antonio
country: United States
facility: Site - 0141
state: Texas
city: Manassas
country: United States
facility: Site - 0109
state: Virginia
city: Kingwood
country: United States
facility: Site - 0137
state: West Virginia
city: Morgantown
country: United States
facility: Site - 0147
state: West Virginia
city: Kenosha
country: United States
facility: Site - 0134
state: Wisconsin
city: Wauwatosa
country: United States
facility: Site - 0121
state: Wisconsin
Study officials:
affiliation: Tourmaline Bio
name: Clinical Trials
role: STUDY_DIRECTOR
References: