JPRN-jRCT2041220079招募中2 期
A Phase II, randomised, placebo-controlled, double-blind, parallel-group, efficacy and safety study of at least 48 weeks of oral BI 685509 treatment in adults with early progressive diffuse cutaneous systemic sclerosis
Ogawa Shintaro0 个研究点目标入组 200 人开始时间: 2022年10月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •- Male or female patients aged 18 years at time of consent (or above legal age).
- •- Patients must fulfil the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for SSc.
- •- Patients must be diagnosed with diffuse cutaneous SSc (widespread skin fibrosis with skin involvement proximal to elbows and/or knees) as defined by LeRoy et al.
- •- SSc disease onset (defined by first non-RP symptom) must be within 5 years of Visit 1.
- •- Evidence of active disease.
排除标准
- •- Any known form of pulmonary hypertension.
- •- Limited cutaneous SSc at screening. Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren syndrome.
- •- Diffusing capacity for carbon monoxide (DLCO) (haemoglobin corrected) <40% of predicted at screening.
- •- Any history of scleroderma renal crisis.
- •- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology [CKD-EPI] formula) or on dialysis at screening.
- •- Cirrhosis of any Child-Pugh class (A, B or C).
- •- Cholestasis at present, or alkaline phosphatase (ALP) > 4 x upper limit of normal (ULN), or ALP > 2 x ULN and gamma-glutamyl transferase (GGT) > 3 x ULN at Screening.
- •- Known, severe gastric antral telangiectasias (watermelon stomach).
- •- Any history of bronchial artery embolization or massive hemoptysis. (Massive hemoptysis is defined as acute bleeding >240 mL in a 24-hour period or recurrent bleeding >100 mL/day over consecutive days).
- •- Active hemoptysis or pulmonary hemorrhage, including events managed by bronchial artery embolization.
- •- Systolic blood pressure <100 mm Hg or known history of moderate or severe symptomatic orthostatic dysregulation as judged by the Investigator before start of trial treatment.
- •- Sitting heart rate (HR) <50 beats per minute (BPM) at the Screening Visit.
- •- Left ventricular ejection fraction <40% prior to screening.
- •- A marked baseline prolongation of QT/QTc interval.
研究者
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