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

Phase 2

Completed

Conditions: Raynaud Phenomenon Secondary to Systemic Sclerosis

Interventions: Drug: Iloprost Injection, for intravenous use
Drug: Placebo IV infusion

Registration Number: NCT03867097

Lead Sponsor: Civi Biopharma, 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iloprost Injection, for intravenous use	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.
Placebo	Placebo IV infusion	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.

Primary Outcome Measures

Name	Time	Method
Change in Frequency of Symptomatic RP Attacks	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. 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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (16): Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸
Phoenix, Arizona, United States
Pacific Arthritis Care Center of Los Angeles
🇺🇸
Los Angeles, California, United States
Stanford University Medical Center
🇺🇸
Palo Alto, California, United States
University of California San Francisco
🇺🇸
San Francisco, California, United States
Georgetown University Medical Center - Department of Rheumatology
🇺🇸
Washington, District of Columbia, United States
Johns Hopkins University School of Medicine
🇺🇸
Baltimore, Maryland, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Robert Wood Johnson Medical School
🇺🇸
New Brunswick, New Jersey, United States
Hospital for Special Surgery
🇺🇸
New York, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
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Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Phoenix, Arizona, United States