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Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03867097•Civi Biopharma, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+16 more criteria

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 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

Key Dates

Start Date

March 7, 2019

Primary Completion Date

August 6, 2019

Completion Date

August 6, 2019

Last Updated

May 25, 2025

Enrollment

ACTUAL participants

Conditions

Raynaud Phenomenon Secondary to Systemic Sclerosis

Interventions

Placebo IV infusion

DRUG

Iloprost Injection, for intravenous use

DRUG