Clinical trial NCT03867097: Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Raynaud Phenomenon Secondary to Systemic Sclerosis
Keywords: systemic sclerosis
raynaud phenomenon
Lead sponsor: Civi Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Frequency of Symptomatic RP Attacks
timeFrame: Day 8 - Day 21 will be compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Los Angeles
country: United States
facility: Pacific Arthritis Care Center of Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center - Department of Rheumatology
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo Medical Center (UTMC) - Ruppert Health Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest Rheumatology PLLC
state: Washington
Study officials:
affiliation: Civibio Pharma, Inc.
name: Wade Benton, Pharm D
role: STUDY_DIRECTOR
References: