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Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)

Primary Purpose

Raynaud Phenomenon Secondary to Systemic Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo IV infusion
Iloprost Injection, for intravenous use
Sponsored by
Eicos Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Raynaud Phenomenon Secondary to Systemic Sclerosis focused on measuring systemic sclerosis, raynaud phenomenon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Arizona Arthritis & Rheumatology Research, PLLC
  • Pacific Arthritis Care Center of Los Angeles
  • Stanford University Medical Center
  • University of California San Francisco
  • Georgetown University Medical Center - Department of Rheumatology
  • Johns Hopkins University School of Medicine
  • University of Michigan
  • Robert Wood Johnson Medical School
  • Hospital for Special Surgery
  • Columbia University Medical Center
  • Cleveland Clinic
  • The University of Toledo Medical Center (UTMC) - Ruppert Health Center
  • University of Pittsburgh Medical Center
  • University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
  • Virginia Mason Medical Center
  • Arthritis Northwest Rheumatology PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Iloprost Injection, for intravenous use

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Frequency of symptomatic RP attacks
The primary efficacy parameter is the change in the weekly frequency of symptomatic RP attacks from baseline.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2019
Last Updated
February 12, 2020
Sponsor
Eicos Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03867097
Brief Title
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eicos Sciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Raynaud Phenomenon Secondary to Systemic Sclerosis
Keywords
systemic sclerosis, raynaud phenomenon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Iloprost Injection, for intravenous use
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Placebo IV infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Iloprost Injection, for intravenous use
Intervention Description
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 Measure Information:
Title
Frequency of symptomatic RP attacks
Description
The primary efficacy parameter is the change in the weekly frequency of symptomatic RP attacks from baseline.
Time Frame
Day 8 - Day 21 will be compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wade Benton, Pharm D
Organizational Affiliation
Civibio Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Pacific Arthritis Care Center of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Georgetown University Medical Center - Department of Rheumatology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5422
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The University of Toledo Medical Center (UTMC) - Ruppert Health Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Arthritis Northwest Rheumatology PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)

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