Actively Recruiting
Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
Led by Hansoh BioMedical R&D Company · Updated on 2024-07-18
160
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects between the ages of 18-75 years.
- History of psoriatic arthritis for at least 6 months and meets Classification Criteria for Psoriatic Arthritis (CASPAR) at screening.
- Active arthritis with at least 3 swollen joints (66 joint count) and 3 tender joints (68 joint count) at screening and baseline.
- Active plaque psoriatic skin lesion or documented history of plaque psoriasis at screening.
- High-sensitivity C-reactive protein (hs-CRP) level of 3 mg/L or higher at screening.
- Either no prior exposure to biologics or failed/intolerant to one TNF-inhibitor.
You will not qualify if you...
- Non-plaque psoriasis types such as guttate, inverse, pustular, erythrodermic or drug-induced psoriasis, except nail psoriasis which is allowed.
- Other autoimmune or autoinflammatory conditions like rheumatoid arthritis, systemic lupus erythematosus, or gout, except inactive inflammatory bowel disease or autoimmune uveitis for at least 12 months.
- Active fibromyalgia syndrome.
- Recent or chronic active infection, or risk of serious infection.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
H
Hejian Zou, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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