CTRI/2023/07/054769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 progressive systemic sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
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
入选标准
- •1. Male or female patients aged =18 years at time of consent (or above legal age, e.g. UK =16 years).
- •2. Patients must fulfil the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for SSc.
- •3. 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.
- •4. SSc disease onset (defined by first non-RP symptom) must be within 5 years of Visit 1.
- •5. 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
- •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 of either chest or abdomen within 6 months of Visit 1
- •Worsening of skin thickening (=2 mRSS points) within 6 months of Visit 1 OR
- •=1 tendon friction rub.
- •6.Elevated biomarkers on Visit 1 (screening) defined as at least
- •one of the following:
- •C-reactive protein (CRP) =6 mg/L (=0.6 mg/dL), OR
- •Erythrocyte sedimentation rate =28 mm/h, OR
- •Krebs von den Lungen 6 (KL-6) =1000 U/mL
- •7. 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 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 interstitial lung disease (ILD) has been confirmed
- •8. Evidence of early fibrosis at Visit 1, defined as a
- •mRSS of =12 points, AND
- •FVC =50% of predicted normal
- •9. If patients receive concomitant treatments for dcSSc, these need to be on stable doses for a predefined period.
- •10. Male patients able to father a child must be willing to use condoms if their sexual partner is a woman of childbearing potential (WOCBP). WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2). Such methods should be used throughout the trial. A list of contraceptive methods meeting these criteria is provided in the CTP
排除标准
- •1. Any known form of pulmonary hypertension.
- •2. Limited cutaneous SSc at screening. Other autoimmune connective tissue diseases, except for fibromyalgia, scleroderma-associated myopathy and secondary Sjogren syndrome.
- •3. Diffusing capacity for carbon monoxide (DLCO) (haemoglobin corrected) <40% of predicted at screening.
- •4. Any history of scleroderma renal crisis.
- •5. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology [CKD-EPI] formula) or on dialysis at screening.
- •6. Cirrhosis of any Child-Pugh class (A, B or C).
- •7. Cholestasis at present, or alkaline phosphatase (ALP) > 4 x upper limit of normal (ULN), or ALP > 2 x ULN and gammaglutamyl transferase (GGT) > 3 x ULN at Screening.
- •8. Known, severe gastric antral telangiectasias (watermelon stomach).
- •9. 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).
- •10. Active hemoptysis or pulmonary hemorrhage, including events managed by bronchial artery embolization.
- •11. 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.
- •12. Sitting heart rate (HR) <50 beats per minute (BPM) at them Screening Visit.
- •13. Known heart failure with left ventricular ejection fraction <40% prior to screening.
- •14. A marked baseline prolongation of QT/QTc interval
研究者
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