Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)

PHASE3CompletedINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

October 14, 2019

Primary Completion Date

June 9, 2021

Study Completion Date

June 9, 2021

Conditions
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Interventions
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.

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.

Trial Locations (30)

10021

Hospital for Special Surgery, New York

10032

Columbia University Medical Center, New York

15261

University of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennsylvania, Philadelphia

20007

Georgetown University Medical Center - Department of Rheumatology, Washington D.C.

21224

Johns Hopkins University School of Medicine, Baltimore

29425

Medical University of South Carolina (MUSC), Charleston

43210

Ohio State University, Columbus

43614

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

44195

Cleveland Clinic, Cleveland

45267

University of Cincinnati - Scleroderma Center, Cincinnati

49546

West Michigan Rheumatology PLLC, Grand Rapids

53226

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee

55369

University of Minnesota Maple Grove, Minneapolis

60611

Northwestern Medical Faculty Foundation, Chicago

68198

University of Nebraska Medical Center, Omaha

70112

University Medical Center New Orleans, New Orleans

77030

University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics, Houston

84132

University of Utah, Salt Lake City

85032

Arizona Arthritis & Rheumatology Research, PLLC, Phoenix

85259

Mayo Clinic - Scottsdale, Scottsdale

85724

University of Arizona - Arthritis Research Center, Tucson

90048

Cedars-Sinai Medical Center, Los Angeles

90059

University of California, Los Angeles Medical Center, Los Angeles

94143

University of California San Francisco, San Francisco

94305

Stanford University Medical Center, Palo Alto

98101

Virginia Mason Medical Center, Seattle

02111

Tufts Medical Center, Boston

48109-5422

University of Michigan, Ann Arbor

08903

Robert Wood Johnson Medical School, New Brunswick

Sponsors
All Listed Sponsors
lead

Civi Biopharma, Inc.

INDUSTRY