2023-509783-23-00已完成2 期
A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis
Horizon Therapeutics Ireland Designated Activity Company46 个研究点 分布在 9 个国家目标入组 167 人开始时间: 2024年9月30日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 46
- 主要终点
- Change from both Baselines in FVC % predicted at Week 52
研究概览
简要总结
The overall objective is to investigate the efficacy, safety and tolerability of HZN-825, a selective antagonist of LPAR1, administered BID to subjects with diffuse cutaneous SSc in a 52-week open-label extension following completion of the randomized, double-blind, 52-week clinical trial (HZNP-HZN-825-301).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Open-label, repeat-dose, multicenter extension trial of HZNP-HZN-825-301
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent.
- •Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301; subjects prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons other than safety or toxicity can be included at the discretion of the Investigator after completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments.
- •Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. "
排除标准
- •Anticipated use of another investigational agent for any condition during the course of the trial.
- •New diagnosis of malignant condition after enrolling in Trial HZNPHZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
- •Women of childbearing potential (WOCBP) or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug. Male subjects must refrain from sperm donation and females from egg/ova donation for this same time period. Women are considered of childbearing potential if they are not postmenopausal and not surgically sterile (documented bilateral salpingectomy, bilateral oophorectomy or hysterectomy). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Fertile male subjects must use a condom throughout the trial and for 4 weeks after the last dose of trial drug. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
- •Pregnant or lactating women.
- •Any new development with the subject's disease or condition or any significant laboratory test abnormality during the course of Trial HZNPHZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk.
- •Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial. "
结局指标
主要结局
Change from both Baselines in FVC % predicted at Week 52
Change from both Baselines in FVC % predicted at Week 52
次要结局
- "1. Change from both Baselines in HAQ-DI at Week 52. 2. Change from both Baselines in MDGA at Week 52. 3. Change from both Baselines in PTGA at Week 52. 4. Change from both Baselines in the Physical Effects subscale of the SSPRO-18 at Week 52. "
研究者
Arati Kanchi
Scientific
Horizon Therapeutics Ireland Designated Activity Company
研究点 (46)
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