Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE July 30, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE October 14, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Raynaud's Phenomenon Secondary to Systemic Sclerosis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo IV infusion
  • 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.
    Intervention: Drug: Iloprost Injection, for intravenous use
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2020)
180
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2019)
160
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kelly Oliver 2677739391 klo@civibio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04040322
Other Study ID Numbers  ICMJE ES-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eicos Sciences, Inc.
Study Sponsor  ICMJE Eicos Sciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wade Benton, Pharm D Eicos Sciences, Inc.
PRS Account Eicos Sciences, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP