intravenous iloprost in subjects with symptomatic raynaud's phenomenon secondary to systemic sclerosis (phase 2)

Conditions: Raynaud Phenomenon Secondary to Systemic Sclerosis

Summary: this is a phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the effect of iloprost on the symptomatic relief of raynaud's phenomenon attacks in subjects with symptomatic raynaud's phenomenon secondary to systemic sclerosis.


Eligibility criteria:
inclusion criteria: * male or female subjects must be greater than or equal to 18 years of age * subjects must have a diagnosis of systemic sclerosis * subjects must have a diagnosis or history of raynaud's phenomenon * subjects must have a minimum of 10 symptomatic raynaud's phenomenon attacks * female subjects of childbearing potential and male subjects must agree to use contraception for the duration of the study * subjects must be willing and able to comply with the study requirements and give informed consent for participation in the study exclusion criteria: * female subjects who are pregnant or breastfeeding * subjects with systolic blood pressure \<85 mmhg * subjects with an estimated glomerular filtration rate \<30 ml/min/1.73 m2 * subjects with child-pugh class b or class c liver disease or an alanine aminotransferase and/or aspartate aminotransferase value \>3 × the upper limit of normal at screening. * subjects with gangrene, digital ulcer infection, or requirement of cervical or digital sympathectomy * subjects with intractable diarrhea or vomiting * subjects with a risk of clinically significant bleeding events including those with coagulation or platelet disorders * subjects with a history of major trauma or hemorrhage * subjects with clinically significant chronic intermittent bleeding such as active gastric antral vascular ectasia or active peptic ulcer disease * subjects who have had any cerebrovascular events * subjects with a history of myocardial infarction or unstable angina within 6 months of screening * subjects with acute or chronic congestive heart failure * subjects with a history of life-threatening cardiac arrhythmias * subjects with a history of hemodynamically significant aortic or mitral valve disease * subjects with more than mild restrictive or congestive cardiomyopathy uncontrolled by medication or implanted device. * subjects with known pulmonary hypertension, pulmonary arterial hypertension, or pulmonary veno-occlusive disease * subjects with a history of significant restrictive lung disease defined as forced vital capacity \<45% predicted and diffusing capacity of the lungs for carbon monoxide \<40% predicted (uncorrected for hemoglobin). * subjects with a history of cervical or digital sympathectomy * subjects with scleroderma renal crisis * subjects with a concomitant life-threatening disease with a life expectancy \<12 months * subjects who have a clinically significant disorder, that in the opinion of the investigator, could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results * subjects who have taken or are currently taking any parenteral, inhaled, or oral prostacyclin or prostacyclin receptor agonists * subjects must not initiate dosing of oral, topical, or intravenous (iv) vasodilators or if currently receiving any vasodilator must have been stably medicated * subjects with any history of acetaminophen intolerability * subjects with any malignancy that requires treatment during the study period, that has required treatment within 1 year of screening, or that is currently not in remission. * subjects who have used any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer)

Keywords: systemic sclerosis raynaud phenomenon