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RDEA3170 · 2 trials · 2 indications
The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.
% change per treatment will be compared.
Timed urinary uric acid excretion per treatment will be compared
Renal clearance of uric acid will be calculated.
Fractional excretion and renal clearance of uric acid will be calculated.
| Arm | Type | Description |
|---|---|---|
| RDEA3170 1 | EXPERIMENTAL | RDEA3170 5mg followed by RDEA3170 7.5mg |
| RDEA3170 2 | EXPERIMENTAL | RDEA3170 10mg followed by RDEA3170 12.5mg |
| RDEA3170 3 | EXPERIMENTAL | RDEA3170 12.5mg followed by RDEA3170 15mg |
| RDEA3170 4 | PLACEBO_COMPARATOR | RDEA3170 Placebo |
| Allopurinol | OTHER | Allopurinol 200mg |
| Cohort 1 | EXPERIMENTAL | The half of patients randomized to this cohort will be dosed in the order of Febuxostat 10mg, RDEA3170 2.5 mg + Febuxostat 10mg, RDEA3170 2.5 mg + Febuxostat 20mg, and Febuxostat 20mg. The other half will be dosed in the reverse order. |
| Cohort 2 | EXPERIMENTAL | The half of patients randomized to this cohort will be dosed in the order of Febuxostat 10mg, RDEA3170 5 mg + Febuxostat 10mg, RDEA3170 5 mg + Febuxostat 20mg, and Febuxostat 20mg. The other half will be dosed in the reverse order. |
| Cohort 3 | EXPERIMENTAL | The half of patients randomized to this cohort will be dosed in the order of Febuxostat 20mg, RDEA3170 5 mg + Febuxostat 20mg, RDEA3170 5 mg + Febuxostat 40mg, and Febuxostat 40mg. The other half will be dosed in the reverse order. |
| Cohort 4 | EXPERIMENTAL | The half of patients randomized to this cohort will be dosed in the order of Febuxostat 20mg, RDEA3170 10 mg + Febuxostat 20mg, RDEA3170 10 mg + Febuxostat 40mg, and Febuxostat 40mg. The other half will be dosed in the reverse order. |
| Cohort 5 | EXPERIMENTAL | RDEA3170 2.5mg, RDEA3170 5mg, RDEA3170 10mg, RDEA3170 15mg |
| Cohort 6 | EXPERIMENTAL | The half of patients randomized to this cohort will be dosed in the order of Benzbromarone 50 mg, Febuxostat 10mg+RDEA3170 2.5 mg, then Febuxostat 20mg+RDEA3170 5 mg. The other half will be dosed in the order of Febuxostat 10mg+RDEA3170 2.5 mg, Febuxostat 20mg+RDEA3170 5 mg, then Benzbromarone 50mg. |
| Name | Type | Description |
|---|---|---|
| RDEA3170 | DRUG | Oral Treatment |
| Allopurinol | DRUG | Oral Treatment |
| Placebo | DRUG | Oral Treatment |
| Febuxostat | DRUG | Oral Treatment |
| Benzbromarone | DRUG | Oral Treatment |
Inclusion Criteria: * Subject meets any of the following criteria and with sUA ≤10.0 mg/dL: 1. sUA level of \>7.0 mg/dL at 7 days prior to baseline with gout; 2. sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabe...
RDEA3170 is an investigational small molecule being studied for the treatment of gout and hyperuricemia, including asymptomatic hyperuricemia. It is a metabolic therapeutic agent in clinical development, though it is not yet approved and remains under investigation.
RDEA3170 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gout and hyperuricemia.
RDEA3170 is in clinical development, with trials completed in Phase 1 and Phase 2. The drug is investigational and has not been approved by regulatory authorities. Its development status reflects ongoing research into its use for gout and hyperuricemia.
RDEA3170 has been studied in two completed clinical trials. NCT02078219 was a Phase 2 dose-finding study in Japanese patients with gout or asymptomatic hyperuricemia, enrolling 204 participants. NCT02317861 was a Phase 1 pharmacodynamic and safety study combining RDEA3170 with febuxostat in male patients with gout or asymptomatic hyperuricemia.
RDEA3170 is also known by its chemical identifier and is being developed under this name by AstraZeneca. No alternative brand names have been disclosed in the clinical trial data, and the drug is distinct from other urate-lowering therapies.