RecruitingPhase 2NCT06176508

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

Sponsor

Hansoh BioMedical R&D Company

Enrollment

160 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

Psoriatic Arthritis

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 future clinical development of HS-10374.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria4

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.

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