Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
- Conditions
- Raynaud Phenomenon Secondary to Systemic Sclerosis
- Interventions
- Drug: Placebo IV infusion
- Registration Number
- NCT03867097
- Lead Sponsor
- Eicos Sciences, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iloprost Injection, for intravenous use Iloprost Injection, for intravenous use Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line. Study drug will be initiated at a starting dose 0.5 ng/kg/min up to 2.0 ng/kg/min. Placebo Placebo IV infusion Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line. Study drug will be initiated at a starting dose 0.5 ng/kg/min up to 2.0 ng/kg/min.
- Primary Outcome Measures
Name Time Method Frequency of symptomatic RP attacks Day 8 - Day 21 will be compared to baseline The primary efficacy parameter is the change in the weekly frequency of symptomatic RP attacks from baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
🇺🇸Houston, Texas, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Arthritis Northwest Rheumatology PLLC
🇺🇸Spokane, Washington, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Pacific Arthritis Care Center of Los Angeles
🇺🇸Los Angeles, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
The University of Toledo Medical Center (UTMC) - Ruppert Health Center
🇺🇸Toledo, Ohio, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Phoenix, Arizona, United States
Georgetown University Medical Center - Department of Rheumatology
🇺🇸Washington, District of Columbia, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States