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

Sponsored by Hansoh BioMedical R&D Company

About this trial

Last updated 2 years ago

Study ID

HS-10374-202

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18 to 75 Years
All Sexes

Trial Timing

Started 2 years ago

What is this trial 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.

What are the participation requirements?

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, which is allowed.

2. 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.

3. Active fibromyalgia syndrome

4. Recent history of active infection, chronic infection history or risk of serious infection.