A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With U
To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administrat
| Condition(s) | Gout |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials. |
| Who can participate | Inclusion Criteria: * Willing and able to give informed consent. * Male and female aged between 18 and 70 years old , regardless of gender. * Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) in the range of (19-30) kg/m2 (including 19 and 30)； * The clinical diagnosis of gout met the criteria of American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2015，patients were in non-acute attack at screening or at least 2 weeks after complete remission of acute attack, and sUA ≥420 μmol/L at screening； * Patients whose serum uric acid level could not reach the target after standard treatment with conventional uric acid-lowering drugs or who were contraindicated or intolerant to conventional uric acid-lowering drugs； * Patients who were willing to stop t |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Shanghai Institute Of Biological Products |
| Locations | Bengbu, Anhui, China |
| Start date | 2023-03-03 |
| NCT ID | NCT06298071 |
| Official listing | https://clinicaltrials.gov/study/NCT06298071 |