- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040322
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
July 13, 2021 updated by: Eicos Sciences, Inc.
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85032
- Arizona Arthritis & Rheumatology Research, PLLC
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic - Scottsdale
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Tucson, Arizona, United States, 85724
- University of Arizona - Arthritis Research Center
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, United States, 90059
- University Of California, Los Angeles Medical Center
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Palo Alto, California, United States, 94305
- Stanford University Medical Center
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San Francisco, California, United States, 94143
- University of California San Francisco
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center - Department of Rheumatology
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Medical Faculty Foundation
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Louisiana
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New Orleans, Louisiana, United States, 70112
- University Medical Center New Orleans
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins University School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109-5422
- University of Michigan
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Grand Rapids, Michigan, United States, 49546
- West Michigan Rheumatology PLLC
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Minnesota
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Minneapolis, Minnesota, United States, 55369
- University of Minnesota Maple Grove
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- Robert Wood Johnson Medical School
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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New York, New York, United States, 10021
- Hospital for Special Surgery
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Ohio
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Cincinnati, Ohio, United States, 45267
- University of Cincinnati - Scleroderma Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Columbus, Ohio, United States, 43210
- Ohio State University
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Toledo, Ohio, United States, 43614
- The University of Toledo Medical Center (UTMC) - Ruppert Health Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh Medical Center
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina (MUSC)
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Texas
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Houston, Texas, United States, 77030
- University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital and the Medical College of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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
Exclusion Criteria:
- 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)
- Subjects with any malignancy that requires treatment during the study period, that has required treatment within 1 year of screening (including excision of skin cancer) 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)
- Subjects who have participated in ES-201 or ES-301 studies and were randomized and treated with study drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
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.
|
Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min.
Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
|
ACTIVE_COMPARATOR: 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.
|
Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min.
Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of symptomatic RP attacks
Time Frame: Day 6 - Day 21 will be compared to baseline
|
The primary efficacy parameter is the change in the weekly frequency of symptomatic RP attacks from baseline
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Day 6 - Day 21 will be compared to baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Wade Benton, Pharm D, Eicos Sciences, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 14, 2019
Primary Completion (ACTUAL)
June 9, 2021
Study Completion (ACTUAL)
June 9, 2021
Study Registration Dates
First Submitted
July 30, 2019
First Submitted That Met QC Criteria
July 30, 2019
First Posted (ACTUAL)
July 31, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 14, 2021
Last Update Submitted That Met QC Criteria
July 13, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Neoplasms
- Connective Tissue Diseases
- Neoplastic Processes
- Peripheral Vascular Diseases
- Sclerosis
- Neoplasm Metastasis
- Scleroderma, Systemic
- Scleroderma, Diffuse
- Raynaud Disease
- Vasodilator Agents
- Platelet Aggregation Inhibitors
- Iloprost
Other Study ID Numbers
- ES-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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