NCT06176508招募中2 期
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
Hansoh BioMedical R&D Company1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年2月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 16
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
HS-10374 Dose 1
Experimental
干预措施: HS-10374 (Drug)
HS-10374 Dose 2
Experimental
干预措施: HS-10374 (Drug)
Placebo
Placebo Comparator
干预措施: HS-10374-matched placebo tablets (Drug)
tofacitinib
Active Comparator
干预措施: Tofacitinib 5Mg Tab,Oral (Drug)
结局指标
主要结局
Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 16
时间窗: At week 16
The ACR 20, ACR 50 or ACR 70 definition of improvement is a 20%, 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 20%, 50% or 70% improvement, respectively, in 3 of the 5 remaining core data set measures (Subject Global Assessment of disease activity, Physician Global Assessment of psoriatic arthritis, Subject global assessment of pain, HAQ-DI, hs-CRP).
次要结局
- Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 16(At week 16)
- Proportion of participants meeting Psoriasis Area and Severity Index (PASI) 75/90 responses at week 16(At week 16)
- Proportion of participants meeting Static physician's global assessment (sPGA) 0/1 score at week 16(At week 16)
- Change from baseline in the dermatology life quality index (DLQI) scores at week 16(At week 16)
- Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 12(At week 12)
- Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR50) response at Week 16(At week 16)
- Incidence of adverse events (AEs), serious adverse events (SAEs)(Baseline to Week 20)
- Change from baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA) at week 16(At week 16)
- Proportion of participants meeting Minimal Disease Activity (MDA) response at week 16(At week 16)
- Change from baseline in dactylitis by Leed's dactylitis index (LDI) at week 16(At week 16)
- Ctrough of HS-10374(Baseline to Week 16)
- Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR70) response at Week 16(At week 16)
- Change from baseline in Psoriasis body surface area (BSA) at week 16(At week 16)
- Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score at week 16(At week 16)
- Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at week 16(At week 16)
- Change from baseline in enthesitis by Leed's enthesitis index (LEI) at week 16(At week 16)
- Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC) at week 16(At week 16)
- Change from baseline in the Short Form-36 Survey (SF-36) score at week 16(At week 16)
- Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis as one of their presentations of PsA at week 16(At week 16)
研究者
研究点 (1)
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