Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01129648 | Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout | PHASE2 | COMPLETED | 87 | — | — | May 1, 2010 | Nov 1, 2010 | Jan 23, 2012 | 18 | United States |
| Arm | Type | Description |
|---|---|---|
| BCX4208 placebo + Allopurinol placebo | PLACEBO_COMPARATOR | Administered daily for 21 days. |
| BCX4208 placebo + Allopurinol 100mg | ACTIVE_COMPARATOR | Administered daily for 21 days. |
| BCX4208 placebo + Allopurinol 200 mg | ACTIVE_COMPARATOR | Administered daily for 21 days. |
| BCX4208 Placebo + Allopurinol 300 mg | ACTIVE_COMPARATOR | Administered daily for 21 days. |
| BCX4208 20 mg + Allopurinol Placebo | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 20 mg + Allopurinol 100 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 20 mg + Allopurinol 200 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 20 mg + Allopurinol 300 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 40 mg + Allopurinol placebo | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 40 mg + Allopurinol 100 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 40 mg + Allopurinol 200 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 40 mg + Allopurinol 300 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 80 mg + Allopurinol Placebo | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 80 mg + Allopurinol 100 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 80 mg + Allopurinol 200 mg | EXPERIMENTAL | Administered daily for 21 days. |
| BCX4208 80 mg + Allopurinol 300 mg | EXPERIMENTAL | Administered daily for 21 days. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Administered daily for 21 days |
| Allopurinol | DRUG | Administered daily for 21 days. |
| BCX4208 | DRUG | Administered daily for 21 days. |
Inclusion Criteria: 1. Age ≥18 to \<70 years, with screening sUA \> 8.0 mg/dL. 2. Diagnosis of gout according to the criteria of the American Rheumatism Association (1977). 3. Be willing and able to take colchicine 0.6 mg per day or naproxen 250 mg twice daily (with proton pump inhibitor if needed)...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Pegloticase, Methotrexate |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE1 | NNC4004-0002 |
| Protalix | PLX | 1 | PHASE2 | PRX-115, Methotrexate |
| TJ Biopharma Co., Ltd. | IMAB | 1 | PHASE2 | Plonmarlimab, Compound betamethasone |