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Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT04040322
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : October 15, 2019
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 : 160 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)
Estimated Study Start Date : October 14, 2019
Estimated Primary Completion Date : March 16, 2020
Estimated Study Completion Date : June 2020

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 <30 mL/min/1.73 m2
  • Subjects with Child-Pugh Class B or Class C liver disease at screening.
  • 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)

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

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Sponsors and Collaborators
Eicos Sciences, Inc.
Investigators
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Study Director: Wade Benton, Pharm D Civibio Pharma, Inc.

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Responsible Party: Eicos Sciences, Inc.
ClinicalTrials.gov Identifier: NCT04040322     History of Changes
Other Study ID Numbers: ES-301
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
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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Neoplasm Metastasis
Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Neoplastic Processes
Neoplasms
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents