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

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ClinicalTrials.gov Identifier: NCT03867097
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Eicos Sciences, Inc.

Brief Summary:
This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the effect of iloprost on the symptomatic relief of Raynaud's Phenomenon attacks in subjects with symptomatic Raynaud's Phenomenon secondary to Systemic Sclerosis.

Condition or disease Intervention/treatment Phase
Raynaud Phenomenon Secondary to Systemic Sclerosis Drug: Placebo IV infusion Drug: Iloprost Injection, for intravenous use Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

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 8 - 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
  • Subjects must have a diagnosis or history of Raynaud's Phenomenon
  • Subjects must have a minimum of 10 symptomatic Raynaud's Phenomenon attacks
  • 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 or an alanine aminotransferase and/or aspartate aminotransferase value >3 × the upper limit of normal at screening.
  • Subjects with gangrene, digital ulcer infection, or requirement of cervical or digital sympathectomy
  • Subjects with intractable diarrhea or vomiting
  • Subjects with a risk of clinically significant bleeding events including those with coagulation or platelet disorders
  • Subjects with a history of major trauma or hemorrhage
  • Subjects with clinically significant chronic intermittent bleeding such as active gastric antral vascular ectasia or active peptic ulcer disease
  • Subjects who have had any cerebrovascular events
  • Subjects with a history of myocardial infarction or unstable angina within 6 months of screening
  • Subjects with acute or chronic congestive heart failure
  • Subjects with a history of life-threatening cardiac arrhythmias
  • Subjects with a history of hemodynamically significant aortic or mitral valve disease
  • Subjects with more than mild restrictive or congestive cardiomyopathy uncontrolled by medication or implanted device.
  • Subjects with 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 a history of cervical or digital sympathectomy
  • Subjects with scleroderma renal crisis
  • 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
  • Subjects must not initiate dosing of oral, topical, or intravenous (IV) vasodilators or if currently receiving any vasodilator must have been stably medicated
  • Subjects with any history of acetaminophen intolerability
  • Subjects with any malignancy that requires treatment during the study period, that has required treatment within 1 year of screening, 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): NCT03867097


Contacts
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Contact: Kelly Oliver 2677739391 klo@civibio.com

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Lidia Espino    415-502-5108    Lidia.Espino@ucsf.edu   
Principal Investigator: Francesco Boin, MD         
United States, Washington
Arthritis Northwest Rheumatology PLLC Recruiting
Spokane, Washington, United States, 99204
Contact: Erica Peterson    509-838-6500 ext 271    epetersen@arthritisnw.com   
Principal Investigator: Howard Kenney, MD         
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: NCT03867097     History of Changes
Other Study ID Numbers: ES-201
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 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 phenomenon

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Sclerosis
Neoplasm Metastasis
Scleroderma, Systemic
Scleroderma, Diffuse
Raynaud Disease
Pathologic Processes
Neoplastic Processes
Neoplasms
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Vasodilator Agents