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

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

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.

Study Overview

• Status: Completed
• Conditions: Raynaud Phenomenon Secondary to Systemic Sclerosis
• Intervention / Treatment: Drug: Placebo IV infusion; Drug: Iloprost Injection, for intravenous use

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Arizona Arthritis & Rheumatology Research, PLLC
  • California
    • Los Angeles, California, United States, 90045
      • Pacific Arthritis Care Center of Los Angeles
    • Palo Alto, California, United States, 94305
      • Stanford University Medical Center
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center - Department of Rheumatology
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University School of Medicine
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5422
      • University of Michigan
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Robert Wood Johnson Medical School
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Toledo, Ohio, United States, 43614
      • The University of Toledo Medical Center (UTMC) - Ruppert Health Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest Rheumatology PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Frequency of Symptomatic RP Attacks	The primary efficacy parameter is the change in the weekly frequency of symptomatic RP attacks from baseline. The baseline weekly frequency of symptomatic RP attacks was defined as the average number of weekly symptomatic RP attacks that occurred during the 10- to 25-day baseline ePRO diary completion period. The double-blind endpoint weekly frequency of symptomatic RP attacks was defined as the average number of weekly symptomatic RP attacks that occurred during Days 8 to 21, inclusive.	Day 8 - Day 21 will be compared to baseline

Collaborators and Investigators

• Sponsor: Civi Biopharma, Inc.
• Investigators: Study Director: Wade Benton, Pharm D, Civibio Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2019
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): August 6, 2019

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: systemic sclerosis; raynaud phenomenon
• Additional Relevant MeSH Terms: Livedoid Vasculopathy; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Connective Tissue Diseases; Neoplastic Processes; Embolism and Thrombosis; Skin Diseases; Skin Diseases, Vascular; Peripheral Vascular Diseases; Thrombosis; Sclerosis; Neoplasm Metastasis; Scleroderma, Systemic; Scleroderma, Diffuse; Raynaud Disease; Platelet Aggregation Inhibitors; Vasodilator Agents; Iloprost
• Other Study ID Numbers: ES-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No