NCT06362759CompletedPhase 2
A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP
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
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 143 (actual)
- First submitted
- 27 Mar 2024
- Start date
- 15 May 2024
- Primary completion date
- 6 Mar 2025
- Lead sponsor
- Tourmaline Bio, Inc., a Novartis Company
- Diseases
- Chronic kidney disease
- NCT number
- NCT06362759
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 143
- From 15 May 2024 to the primary completion date, 6 Mar 2025
- 38 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.