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Trial record 2 of 9 for:    iloprost | Systemic Sclerosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04040322
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Eicos Sciences, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Raynaud's Phenomenon Secondary to Systemic Sclerosis Drug: Placebo IV infusion Drug: Iloprost Injection, for intravenous use Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Iloprost

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.
Drug: Placebo IV infusion
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.
Drug: Iloprost Injection, for intravenous use
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.




Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040322


Contacts
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Contact: Kelly Oliver 2677739391 klo@civibio.com

Locations
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United States, Arizona
Arizona Arthritis & Rheumatology Research, PLLC Recruiting
Phoenix, Arizona, United States, 85032
Contact: Jessica Shelton    480-768-7798    Jessica.Shelton@azarthritis.com   
Principal Investigator: Saima Chohan, MD         
Mayo Clinic - Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Andrea Francone    480-301-6198    francone.andrea@mayo.edu   
Principal Investigator: Leroy Griffing, MD         
University of Arizona - Arthritis Research Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Jazmin Dagnino    520-626-8379    jazmindagnino@arthritis.arizona.edu   
Principal Investigator: Kent Kwoh, MD         
United States, California
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Bonnie Paul    310-423-1232    bonnie.paul@cshs.org   
Principal Investigator: Francesco Boin, MD         
University of California, Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90059
Contact: Maria I Verdel       MVerdel@mednet.ucla.edu   
Principal Investigator: Suzanne Kafaja, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94305
Contact: Joel Nicholus    650-725-4612    nicholus@stanford.edu   
Principal Investigator: Lorinda Chung, MD         
University of California San Francisco Completed
San Francisco, California, United States, 94143
United States, District of Columbia
Georgetown University Medical Center - Department of Rheumatology Recruiting
Washington, District of Columbia, United States, 20007
Contact: Sabrina Elliott    202-444-6211    se510@georgetown.edu   
Principal Investigator: Virginia Steen, MD         
United States, Illinois
Northwestern Medical Faculty Foundation Recruiting
Chicago, Illinois, United States, 60611
Contact: Kathleen Aren       kathleen.aren@northwestern.edu   
Principal Investigator: Chase Correia, MD         
United States, Louisiana
University Medical Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Shana Lennard    504-702-5171    shana.lennard@lcmchealth.org   
Principal Investigator: Lesley Ann Saketkoo         
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21224
Contact: Gwendolyn Leatherman    410-550-8582    gleathe@jhmi.edu   
Principal Investigator: Ami Shah, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Mary Hays       mhays@tuftsmedicalcenter.org   
Principal Investigator: Harrison Farber, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-5422
Contact: Sara Jaafar    734-232-2119    jaafarsa@med.umich.edu   
Principal Investigator: Vivek Nagaraja, MD         
West Michigan Rheumatology PLLC Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Vicky Brougham, LPN         
Principal Investigator: Richard Martin, MD         
United States, Minnesota
University of Minnesota Maple Grove Recruiting
Minneapolis, Minnesota, United States, 55369
Contact: Rodolfo Batres       rbatres@umn.edu   
Principal Investigator: Erik Peterson, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Cindy Marr    402-559-4873    cmarr@unmc.edu   
Principal Investigator: Marcus Snow, MD         
United States, New Jersey
Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Fei Chen    732-418-8476    chenf2@rwjms.rutgers.edu   
Principal Investigator: Vivien Hsu, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Beemnet Amdemicael    212-774-2123    amdemicaelb@hss.edu   
Principal Investigator: Jessica Gordon, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Rachel Broderick    212-342-2713    rb3173@cumc.columbia.edu   
Principal Investigator: Elana Bernstein, MD         
United States, Ohio
University of Cincinnati - Scleroderma Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Tammy Roads    513-558-2148    roadst@ucmail.uc.edu   
Principal Investigator: Surabhi Khanna, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sonya Crook    216-444-3290    crooks@ccf.org   
Principal Investigator: Soumya Chatterjee, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Hilary Kleppel       hilary.kleppel@osumc.edu   
Principal Investigator: Ali Ajam, MD         
The University of Toledo Medical Center (UTMC) - Ruppert Health Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Jennifer Gilmore    419-383-6761    Jennifer.gilmore@utoledo.edu   
Principal Investigator: Bashar Kahaleh, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Hannah McCague    215-614-4426    hannah.mccague@pennmedicine.upenn.edu   
Principal Investigator: Peter Merkel, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Alexandra Boucher       alb329@pitt.edu   
Principal Investigator: Siamak Moghadam-Kia, MD         
United States, South Carolina
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Nathan Wilson       wilsonn@musc.edu   
Principal Investigator: Edwin Smith, MD         
United States, Texas
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics Recruiting
Houston, Texas, United States, 77030
Contact: Patricia Gonzales    713-500-7118    patricia.gonzales@uth.tmc.edu   
Principal Investigator: Maureen Mayes, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Caitlin Romney    801-587-1069    caitlin.romney@hsc.utah.edu   
Principal Investigator: Tracy Frech, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Kate Duran    206-287-6268    Kate.Duran@virginiamason.org   
Principal Investigator: Jeffrey Carlin, MD         
United States, Wisconsin
Froedtert Hospital and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Amy Blair       ablair@mcw.edu   
Principal Investigator: Mary Ellen Csuka, MD         
Sponsors and Collaborators
Eicos Sciences, Inc.
Investigators
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Study Director: Wade Benton, Pharm D Eicos Sciences, Inc.
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Responsible Party: Eicos Sciences, Inc.
ClinicalTrials.gov Identifier: NCT04040322    
Other Study ID Numbers: ES-301
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eicos Sciences, Inc.:
systemic sclerosis
raynaud's phenomenon
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Iloprost
Neoplasm Metastasis
Raynaud Disease
Pathologic Processes
Neoplastic Processes
Neoplasms
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents