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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01407874 | A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency | PHASE2 | COMPLETED | 20 | — | — | Sep 1, 2011 | Jul 1, 2012 | Nov 20, 2013 | 10 | United States |
| NCT01265264 | Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol | PHASE2 | COMPLETED | 279 | — | — | Dec 1, 2010 | Feb 1, 2013 | Nov 20, 2013 | 54 | United States |
Level of CD4+ lymphocytes to be measured at Day 85 compared to baseline.
Level of serum uric acid levels be measured at Day 85 to evaluate in subjects with Gout.
| Arm | Type | Description |
|---|---|---|
| Placebo | EXPERIMENTAL | Placebo + Allopurinol 200mg |
| Ulodesine (BCX4208) 5mg | EXPERIMENTAL | BCX4208 5mg + Allopurinol 200 mg |
| Ulodesine (BCX4208) 10mg | EXPERIMENTAL | BCX4208 10mg + Allopurinol 200mg |
| ulodesine Placebo + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| ulodesine 5mg + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| ulodesine 10mg + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| ulodesine 20mg + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| ulodesine 40mg + Allopurinol 300mg | EXPERIMENTAL | Oral dose administered daily for 84 days. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Oral dose administered daily for 84 days. |
| Ulodesine (BCX4208) 5 mg | DRUG | Oral dose administered daily for 84 days. |
| Ulodesine (BCX4208) 10 mg | DRUG | Oral dose administered daily for 84 days. |
| ulodesine | DRUG | Oral dose administered daily for 84 days. |
Inclusion Criteria: 1. Age ≥ 18 to \< 70 years 2. Have read and signed the Informed Consent Form 3. Documented diagnosis of gout 4. Documented moderate renal insufficiency 5. Calculated creatinine clearance of ≥ 30 and \< 60 mL/min 6. Willing and able to take allopurinol 200 mg every day for the du...
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| Amgen Inc. | AMGN | 1 | PHASE3 | Pegloticase, Methotrexate |
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