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This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics study of 6 different dose regimens of ABP-671 compared with placebo. The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD or BID dosing. Each dose group will have 3 stages following screening: Run-in, Dose Evaluation, and Follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABP-671 | Experimental | The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD or BID dosing. |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-671 | Drug | ABP-671 Tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percentage change in serum uric acid (sUA) levels | Baseline to the end of the 4-week Dose Evaluation Period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean sUA | Baseline to the end of the 4-week Dose Evaluation Period | |
| Mean percentage change and change in mean sUA between cohorts | Baseline to the end of the 4-week Dose Evaluation Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratus - Canberra Clinic | Canberra | Australia | ||||
| Paratus - Central Coast Clinic |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| Drug |
Placebo |
|
| Percentage of patients achieving sUA of < 6.0 mg/dL (0.357 mmol/L), < 5.0 mg/dL (0.297 mmol/L), and < 4.0 mg/dL (0.238 mmol/L) | Baseline to the end of the 4-week Dose Evaluation Period |
| Change in mean sUA compared between BID and QD dosing | Baseline to the end of the 4-week Dose Evaluation Period |
| Kanwal |
| Australia |
| Peninsula Private Hospital | Kippa-Ring | Australia |
| Emeritus Research - Melbourne | Melbourne | Australia |
| Paratus - Western Sydney Clinic | Sydney | Australia |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |