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

Raynaud Phenomenon Secondary to Systemic Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867097
• Other study ID #: ES-201
• Status: Completed
• Phase: Phase 2
• Start date: March 4, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2020
• Source: Eicos Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Raynaud Disease
• Raynaud Phenomenon Secondary to Systemic Sclerosis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics	Houston	Texas
United States	Pacific Arthritis Care Center of Los Angeles	Los Angeles	California
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Arizona Arthritis & Rheumatology Research, PLLC	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California San Francisco	San Francisco	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Arthritis Northwest Rheumatology PLLC	Spokane	Washington
United States	The University of Toledo Medical Center (UTMC) - Ruppert Health Center	Toledo	Ohio
United States	Georgetown University Medical Center - Department of Rheumatology	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eicos Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of symptomatic RP attacks	The primary efficacy parameter is the change in the weekly frequency of symptomatic RP attacks from baseline.	Day 8 - Day 21 will be compared to baseline