Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)

• Status: Completed
• Trial end date: 2019-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eicos Sciences, Inc.
• Treatments: Iloprost

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)