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

Completed · Phase 2 · Has a placebo group

Conditions studied: Raynaud Phenomenon Secondary to Systemic Sclerosis

In brief

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.

Key facts

Study ID

NCT03867097

Run by

Civi Biopharma, Inc.

People needed

34

Starts

2019-03-07

Expected to finish

2019-08-06

Last updated by the study team

2025-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States
• Pacific Arthritis Care Center of Los Angeles — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• University of California San Francisco — San Francisco, California, United States
• Georgetown University Medical Center - Department of Rheumatology — Washington D.C., District of Columbia, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The University of Toledo Medical Center (UTMC) - Ruppert Health Center — Toledo, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics — Houston, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Arthritis Northwest Rheumatology PLLC — Spokane, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.