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

NCT ID: NCT03867097

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-07
• Study Completion Date: 2019-08-06

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.

Conditions

Raynaud Phenomenon Secondary to Systemic Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo IV infusion

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Iloprost Injection, for intravenous use

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Civi Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wade Benton, Pharm D

Role: STUDY_DIRECTOR

Civibio Pharma, Inc.

Locations

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 D.C., 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

Cleveland Clinic

Cleveland, Ohio, United States

The University of Toledo Medical Center (UTMC) - Ruppert Health Center

Toledo, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics

Houston, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Arthritis Northwest Rheumatology PLLC

Spokane, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ES-201

Identifier Type: -

Identifier Source: org_study_id