Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
Recruiting · NCT06176508 · Interventional (participants receive a specific treatment) · Lead sponsor: Hansoh BioMedical R&D Company
View the official record on ClinicalTrials.gov →Interventions studied
HS-10374HS-10374-matched placebo tabletsTofacitinib 5Mg Tab,Oral
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female subjects between the ages of 18-75 years.
- Has a history of psoriatic arthritis (PsA) for at least 6 months, and meets the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening.
- Active arthritis as shown ≥ 3 swollen joints (66 joints) and ≥ 3 tender joints (68 joints) at both screening and baseline.
- Active plague psoriatic skin lesion or documented history of plague psoriatic at screening.
- hs-CRP ≥ 3mg/L at screening.
- 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
- Non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis), with the exception of nail psoriasis, which is allowed.
- Other autoimmune or autoinflammatory condition ( ie, rheumatoid arthritis, systemic lupus erythematous, gout), with the exception of inflammatory bowel disease and/or autoimmune uveitis being inactive at least 12 months before the screening, as assessed by the investigator.
- Active fibromyalgia syndrome
- Recent history of active infection, chronic infection history or risk of serious infection.
Where it is running
1 location listed.
- Huashan Hospital affiliated to Fudan University - Shanghai, Shanghai Municipality, China