A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
NCT06362759 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143
Last updated 2026-02-24
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.
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
- DRUG
-
TOUR006 - 50 MG
TOUR006 50 MG
- DRUG
-
TOUR006 - 25 MG
TOUR006 25 MG
- DRUG
-
TOUR006 - 15 MG
TOUR006 15 MG
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
Tourmaline Bio, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Tourmaline Bio
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-15
- Primary Completion
- 2025-03-06
- Completion
- 2025-12-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects
NCT05108259 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Tocilizumab in Patients With Rheumatoid Arthritis
NCT01187563 ·Status: COMPLETED
-
A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
NCT00718718 ·Status: COMPLETED ·Phase: PHASE2
-
Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
NCT01856309 ·Status: COMPLETED ·Phase: PHASE3
-
Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis
NCT02837146 ·Status: UNKNOWN ·Phase: PHASE3
-
Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR
NCT06130540 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis
NCT01941095 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate
NCT01245452 ·Status: COMPLETED ·Phase: NA
-
Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
NCT00144573 ·Status: COMPLETED ·Phase: NA
-
An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice
NCT02552940 ·Status: COMPLETED
-
Tocilizumab Effect on microRNA Expression and Adipokine Levels in Rheumatoid Arthritis Patients
NCT03149796 ·Status: COMPLETED
-
A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)
NCT02797769 ·Status: COMPLETED
-
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis
NCT02531178 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
NCT01706926 ·Status: COMPLETED ·Phase: PHASE2
-
Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis
NCT00160693 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)
NCT01604343 ·Status: COMPLETED ·Phase: PHASE3
-
Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.
NCT01770379 ·Status: TERMINATED ·Phase: PHASE3
-
Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis
NCT02659150 ·Status: TERMINATED ·Phase: PHASE4
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants
NCT06115967 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy
NCT03155347 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe
NCT06402513 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients
NCT01559103 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting
NCT01664104 ·Status: COMPLETED
-
Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis
NCT00712114 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis
NCT01050998 ·Status: COMPLETED ·Phase: PHASE2