Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)

Completed · Phase 3 · Has a placebo group

Conditions studied: Raynaud's Phenomenon Secondary to Systemic Sclerosis

In brief

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with systemic sclerosis.

Key facts

Study ID

NCT04040322

Run by

Civi Biopharma, Inc.

People needed

198

Starts

2019-10-14

Expected to finish

2021-06-09

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 as defined by the 2013 American College of Rheumatology criteria/EULAR criteria
• Subjects must have a diagnosis or history of Raynaud's Phenomenon, self-reported or reported by a physician, with at least a 2-phase color change in finger(s) of pallor, cyanosis, and/or reactive hyperemia in response to cold exposure or emotion
• Subjects must have a minimum of 10 symptomatic Raynaud's Phenomenon attacks, documented in the electronic patient-reported outcomes (ePRO) diary, occurring over at least 3 separate days of the 3- to 5-day eligibility period
• Subjects must complete a minimum of 80% of the daily ePRO diary entry during the baseline period
• 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 <15 mL/min/1.73 m2
• Subjects with an alanine aminotransferase and/or aspartate aminotransferase value >3 × the upper limit of normal at screening
• Subjects who have a digital ulcer infection within 30 days of screening
• Subjects with a history of cervical or digital sympathectomy, or botulism toxin injections in their hands [for RP or digital ulcers] within 90 days of screening. Subjects should not have a planned botulism toxin or sympathectomy during their participation in the study.
• Subjects with gangrene or digital amputation within 6 months of screening
• Subjects with current intractable diarrhea or vomiting
• Subjects with a risk of clinically significant bleeding events, including those with coagulation or platelet disorders at screening
• Subjects with a history of major trauma or hemorrhage within 30 days of screening.
• Subjects with clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of screening
• Subjects who have had any cerebrovascular events (eg, transient ischemic attack or stroke) within 6 months of screening
• Subjects with a history of myocardial infarction or unstable angina within 6 months of screening. Subjects should not have a planned coronary procedure during their participation in the study
• Subjects with acute or chronic congestive heart failure (New York Heart Association Class III [moderate] or Class IV [severe]) at screening
• Subjects with a history of more than mild restrictive or congestive cardiomyopathy uncontrolled by medication or implanted device
• Subjects with a history of life-threatening cardiac arrhythmias
• Subjects with a history of hemodynamically significant aortic or mitral valve disease
• Subjects with a history of 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 scleroderma renal crisis within 6 months of screening
• 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 (eg, epoprostenol, treprostinil, iloprost, and selexipag) within 8 weeks of screening
• Subjects who have initiated or had a dose change of any of the following within 2 weeks of screening: oral, topical, or intravenous (IV) vasodilators (eg, calcium channel blockers, phosphodiesterase-5 (PDE5) inhibitors [eg, sildenafil, tadalafil, or vardenafil], nitrates, and fluoxetine)
• Subjects with any history of acetaminophen intolerability (eg, allergic reaction to acetaminophen)

Where it is running

• Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States
• Mayo Clinic - Scottsdale — Scottsdale, Arizona, United States
• University of Arizona - Arthritis Research Center — Tucson, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, Los Angeles Medical Center — 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
• Northwestern Medical Faculty Foundation — Chicago, Illinois, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• West Michigan Rheumatology PLLC — Grand Rapids, Michigan, United States
• University of Minnesota Maple Grove — Minneapolis, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, 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
• University of Cincinnati - Scleroderma Center — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• The University of Toledo Medical Center (UTMC) - Ruppert Health Center — Toledo, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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