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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02139046 | Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout | PHASE3 | COMPLETED | 1,790 | — | — | Apr 1, 2014 | Nov 1, 2015 | Nov 3, 2016 | 192 | United States |
| NCT02128490 | Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment | PHASE2 | COMPLETED | 189 | — | — | May 1, 2014 | Oct 1, 2015 | Nov 3, 2016 | 89 | United States |
| Arm | Type | Description |
|---|---|---|
| Febuxostat IR 40 mg | ACTIVE_COMPARATOR | Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Febuxostat IR 80 mg | ACTIVE_COMPARATOR | Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Febuxostat XR 40 mg | EXPERIMENTAL | Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Febuxostat XR 80 mg | EXPERIMENTAL | Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Placebo | PLACEBO_COMPARATOR | Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject's eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months. |
| Name | Type | Description |
|---|---|---|
| Febuxostat IR | DRUG | Febuxostat IR over-encapsulated tablets |
| Febuxostat XR | DRUG | Febuxostat XR over-encapsulated capsules |
| Febuxostat placebo | DRUG | Febuxostat placebo-matching capsules |
| Colchicine | DRUG | Colchicine tablets |
| Naproxen | DRUG | Naproxen tablets |
| Lansoprazole | DRUG | Lansoprazole capsules |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...
| 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 |