Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TOUR006 · 2 trials · 10 indications
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.
| Arm | Type | Description |
|---|---|---|
| TOUR006 - 50 MG | EXPERIMENTAL | 50 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints) |
| TOUR006 - 25 MG | EXPERIMENTAL | 25 mg administered subcutaneously at Day 1 and Day 90 (Placebo administered at 30, 60, 120, and 150 Day timepoints) |
| TOUR006 - 15 MG | EXPERIMENTAL | 15 mg administered subcutaneously at Days 1, 30, 60, 90, 120, and 150 |
| Placebo | PLACEBO_COMPARATOR | Administered subcutaneously at Days 1, 30, 60, 90, 120, and 150 |
| TOUR006 - 20 MG | EXPERIMENTAL | In part A of the study, participants will receive a total of three 20 mg subcutaneous injections: 1 injection every 8 weeks (Day 1, Week 8, Week 16) followed by treatment in part B of the study based on proptosis response and rescue therapy use. |
| Name | Type | Description |
|---|---|---|
| TOUR006 - 50 MG | DRUG | TOUR006 50 MG |
| TOUR006 - 25 MG | DRUG | TOUR006 25 MG |
| TOUR006 - 15 MG | DRUG | TOUR006 15 MG |
| Placebo | OTHER | Placebo |
| TOUR006 - 20 MG | DRUG | TOUR006 20 MG |
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, ...
TOUR006 is an investigational small molecule developed by Tourmaline Bio, Inc. (ticker TRML). It is being studied in Phase 2 clinical trials for chronic kidney disease and thyroid eye disease. It is designed to target IL-6, a cytokine, and is not yet approved for any indication.
TOUR006 is being evaluated for the treatment of chronic kidney disease and thyroid eye disease. In chronic kidney disease, it is studied in patients with elevated high-sensitivity C-reactive protein. Both uses remain investigational and are in Phase 2 clinical development.
TOUR006 targets IL-6, a cytokine. By binding to this target, the drug is designed to modulate IL-6 signaling, which is associated with inflammation. This mechanism underlies its study in conditions where inflammation plays a role, such as chronic kidney disease with elevated hs-CRP and thyroid eye disease.
TOUR006 is developed by Tourmaline Bio, Inc., which trades under the ticker TRML. The company is the sponsor of the clinical trials evaluating the drug in chronic kidney disease and thyroid eye disease.
TOUR006 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. One Phase 2 trial in chronic kidney disease has been completed, and a Phase 2 trial in thyroid eye disease is active but not recruiting.
TOUR006 has been studied in two Phase 2 trials. NCT06362759 evaluated TOUR006 in patients with chronic kidney disease and elevated hs-CRP and is completed, with 143 participants. NCT06088979 is investigating TOUR006 in participants with thyroid eye disease and is active but not recruiting, with 79 participants.