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

NCT03867097 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ES-201
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 16

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

Keywords

systemic sclerosis; raynaud phenomenon

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Iloprost Injection, for intravenous use

ACTIVE COMPARATOR

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

Interventions

Placebo IV infusion 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.

Placebo

Iloprost Injection, for intravenous use 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Civi Biopharma, Inc.: lead

Study Sites (16)

Arizona Arthritis & Rheumatology Research, PLLC

Phoenix, Arizona, 85032, United States

Location

Pacific Arthritis Care Center of Los Angeles

Los Angeles, California, 90045, United States

Location

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Georgetown University Medical Center - Department of Rheumatology

Washington D.C., District of Columbia, 20007, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5422, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

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

Toledo, Ohio, 43614, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics

Houston, Texas, 77030, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Arthritis Northwest Rheumatology PLLC

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Raynaud Disease

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Chief Executive Officer
• Organization: CiVi Biopharma, Inc.

sj@civibio.com

301-968-2390

Study Officials

• Wade Benton, Pharm D

  Civibio Pharma, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 7, 2019
• Study Start: March 7, 2019
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)