Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT06176508

Run by

Hansoh BioMedical R&D Company

People needed

160

Starts

2024-02-26

Expected to finish

2026-08-28

Last updated by the study team

2024-07-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

• Huashan Hospital affiliated to Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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