Status:
RECRUITING
Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 futu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 28 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06176508
Start Date
February 26 2024
End Date
August 28 2026
Last Update
July 18 2024
Active Locations (1)
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1
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040