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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03867097
• Date of registration: 06/03/2019
• Prospective Registration: No
• Primary sponsor: Eicos Sciences, Inc.
• Public title: Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
• Scientific 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
• Date of first enrolment: March 4, 2019
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03867097
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Wade Benton, Pharm D
• Affiliation: Civibio Pharma, Inc.

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Raynaud Phenomenon Secondary to Systemic Sclerosis

Intervention(s)

Drug: Iloprost Injection, for intravenous use

Drug: Placebo IV infusion

Primary Outcome(s)

Frequency of symptomatic RP attacks [Time Frame: Day 8 - Day 21 will be compared to baseline]

Secondary ID(s)

ES-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors