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RECRUITINGPhase 2INTERVENTIONAL

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

A Randomized, Double-blind, Placebo- and Comparator-controlled, Multicenter, Phase 2 Trial to Assess the Efficacy and Safety of HS-10374 in Adults With Active Psoriatic Arthritis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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). Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

HS-10374

Administered orally QD for 16 weeks

DRUG

HS-10374-matched placebo tablets

Administered orally QD for 16 weeks

DRUG

Tofacitinib 5Mg Tab,Oral

Administered orally BID for 16 weeks

Locations (1)

Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China