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

T

Tourmaline Bio

Status and phase

Enrolling
Phase 2

Conditions

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

Treatments

Drug: TOUR006 - 50 MG
Drug: TOUR006 - 15 MG
Drug: TOUR006 - 25 MG
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06362759
TOUR006-C01

Details and patient eligibility

About

This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 in participants with chronic kidney disease and elevated hs-CRP.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
  • 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 12 months
  • Any history of a serious opportunistic infection
  • Known history of immunodeficiency
  • History of gastrointestinal ulceration or perforation
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 4 patient groups, including a placebo group

TOUR006 - 50 MG
Experimental group
Description:
50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
Treatment:
Drug: TOUR006 - 50 MG
TOUR006 - 25 MG
Experimental group
Description:
25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints)
Treatment:
Drug: TOUR006 - 25 MG
TOUR006 - 15 MG
Experimental group
Description:
15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Treatment:
Drug: TOUR006 - 15 MG
Placebo
Placebo Comparator group
Description:
Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150
Treatment:
Other: Placebo

Trial contacts and locations

5

Loading...

Central trial contact

Tourmaline Bio

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems