Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthri
This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of active psoriatic arthritis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.
| Condition(s) | Psoriatic Arthritis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of active psoriatic arthritis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374. |
| Who can participate | Inclusion Criteria: 1. Male or female subjects between the ages of 18-75 years. 2. Has a history of psoriatic arthritis (PsA) for at least 6 months, and meets the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening. 3. Active arthritis as shown ≥ 3 swollen joints (66 joints) and ≥ 3 tender joints (68 joints) at both screening and baseline. 4. Active plague psoriatic skin lesion or documented history of plague psoriatic at screening. 5. hs-CRP ≥ 3mg/L at screening. 6. Subjects either (i) do not have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 TNF-inhibitor (TNFi-experienced). Exclusion Criteria: 1. Non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis), with the exception of nail psoriasis |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Hansoh BioMedical R&D Company |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2024-02-26 |
| NCT ID | NCT06176508 |
| Official listing | https://clinicaltrials.gov/study/NCT06176508 |