A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extende
The purpose of this study is to evaluate the efficacy, safety, tolerability and drug survival of guselkumab in high-dose and extended-interval versus standard-dose in Chinese participants with moderate to severe plaque psoriasis.
| Condition(s) | Psoriasis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The purpose of this study is to evaluate the efficacy, safety, tolerability and drug survival of guselkumab in high-dose and extended-interval versus standard-dose in Chinese participants with moderate to severe plaque psoriasis. |
| Who can participate | Inclusion Criteria: * Has a diagnosis of plaque-type psoriasis (with or without \[Psoriatic Arthritis\] PsA) for at least 6 months before the first administration of study drug. * Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score \>=3, or Investigator's Global Assessment (IGA) \>=3, or Affected Body Surface Area (BSA) \>= 10% at baseline (Week 0). * Be suitable for receiving systemic treatment of psoriasis, as whether biologic-naïve or biologic-experienced participant. * A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections. * Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical e |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2024-07-10 |
| NCT ID | NCT07532486 |
| Official listing | https://clinicaltrials.gov/study/NCT07532486 |