CTIS2022-500332-11-00招募中1 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 progressive systemic sclerosis - 1366-0031
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 18 至 64（—）
- 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, e.g. UK =16 years)., Patients must fulfil the 2013 ACR/EULAR classification criteria for SSc., Patients must be diagnosed with limited or diffuse cutaneous SSc as defined by LeRoy et al. Patients diagnosed with limited cutaneous SSc may be included if they are anti Scl-70 antibody positive., Diffuse cutaneous SSc disease onset (defined by first non-RP symptom) must be within 7 years of Visit 1. Limited cutaneous SSc onset must be within 2 years of Visit 1, Evidence of active disease, defined as having at least one of the following: - New onset of SSc within the last 2 years of Visit 1 OR - New skin involvement or worsening of two new body areas within 6 months of Visit 1 (out of the 17 body areas defined by mRSS assessment, documented in clinical files) OR - New involvement or worsening of one new body area if either chest or abdomen within 6 months of Visit 1 OR - Worsening of skin thickening (e.g. =2 mRSS points) within 6 months of Visit 1 OR - =1 tendon friction rub., Elevated biomarkers on Visit 1 (screening) defined as at least one of the following: - CRP =6 mg/L (=0.6 mg/dL), OR - Erythrocyte sedimentation rate (ESR) =28 mm/h, OR - KL-6 =1000 U/mL. --> If none of the three criteria are met or should not be available, the patient can be entered if the mDAI is = 2.5., Evidence of significant vasculopathy, defined as: - Active DU(s) on Visit 1 OR - Documented history of DU(s), OR - Previous treatment of RP with prostacyclin analogues or = 1 other medications, including calcium channel blockers, nitrates, NO donors in any form, including topical; phosphodiesterase 5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil); nonspecific PDE5 inhibitors (theophylline, dipyridamole) OR - RP with elevated CRP =6 mg/L --> If none of the four criteria above are met, the patient can be entered if the diagnosis of ILD has been confirmed, Further inclusion criteria apply.
排除标准
- •Any known form of pulmonary hypertension., Pulmonary disease with FVC <50% of predicted 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 within the last 6 months., Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (CKD-EPI formula) or on dialysis at screening., Cirrhosis of any Child-Pugh class (A, B or C), Cholestasis at present, or ALP > 4 x ULN, or ALP > 2 x ULN and GGT > 3 x ULN at screening., Further criteria apply.
研究者
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