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 being developed for Thyroid Eye Disease and Chronic Kidney Diseases. In Thyroid Eye Disease, it is being studied in participants 18 to 80 years of age. In Chronic Kidney Disease, it is being evaluated in patients with elevated high-sensitivity C-reactive protein (hs-CRP).
TOUR006 targets IL-6, a cytokine involved in inflammatory pathways. By targeting IL-6, the drug aims to modulate inflammation that contributes to conditions like Thyroid Eye Disease and Chronic Kidney Disease. This mechanism is central to its investigational use in these indications.
TOUR006 is being developed by Tourmaline Bio, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol TRML. Tourmaline Bio is advancing TOUR006 through clinical trials for Thyroid Eye Disease and Chronic Kidney Disease.
TOUR006 is in Phase 2 clinical development. It is not FDA approved and remains investigational. The drug is being studied in two Phase 2 trials: one for Thyroid Eye Disease and one for Chronic Kidney Disease with elevated hs-CRP. Both trials are randomized, double-blind, and placebo-controlled.
TOUR006 is being studied in two Phase 2 clinical trials. NCT06088979 is an active, not recruiting study in Thyroid Eye Disease with 79 participants across multiple countries. NCT06362759 is a completed study in Chronic Kidney Disease with elevated hs-CRP, enrolling 143 participants in the United States.
Yes, TOUR006 is also known as TOUR006 - 20 MG. This alternative name refers to the same drug, likely indicating a specific dosage form or strength. Readers searching for either name will find information about the same investigational small molecule being developed by Tourmaline Bio.