Status:
COMPLETED
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
Lead Sponsor:
Civi Biopharma, Inc.
Conditions:
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iloprost on the frequency of and relief from symptomatic digital ischemic epis...
Eligibility Criteria
Inclusion
- Male or female subjects must be greater than or equal to 18 years of age.
- Subjects must have a diagnosis of Systemic Sclerosis as defined by the 2013 American College of Rheumatology criteria/EULAR criteria
- Subjects must have a diagnosis or history of Raynaud's Phenomenon, self-reported or reported by a physician, with at least a 2-phase color change in finger(s) of pallor, cyanosis, and/or reactive hyperemia in response to cold exposure or emotion
- Subjects must have a minimum of 10 symptomatic Raynaud's Phenomenon attacks, documented in the electronic patient-reported outcomes (ePRO) diary, occurring over at least 3 separate days of the 3- to 5-day eligibility period
- Subjects must complete a minimum of 80% of the daily ePRO diary entry during the baseline period
- 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
- Female subjects who are pregnant or breastfeeding
- Subjects with systolic blood pressure \<85 mmHg
- Subjects with an estimated glomerular filtration rate \<15 mL/min/1.73 m2
- Subjects with an alanine aminotransferase and/or aspartate aminotransferase value \>3 × the upper limit of normal at screening
- Subjects who have a digital ulcer infection within 30 days of screening
- Subjects with a history of cervical or digital sympathectomy, or botulism toxin injections in their hands \[for RP or digital ulcers\] within 90 days of screening. Subjects should not have a planned botulism toxin or sympathectomy during their participation in the study.
- Subjects with gangrene or digital amputation within 6 months of screening
- Subjects with current intractable diarrhea or vomiting
- Subjects with a risk of clinically significant bleeding events, including those with coagulation or platelet disorders at screening
- Subjects with a history of major trauma or hemorrhage within 30 days of screening.
- Subjects with clinically significant chronic intermittent bleeding, such as active gastric antral vascular ectasia or active peptic ulcer disease, within 60 days of screening
- Subjects who have had any cerebrovascular events (eg, transient ischemic attack or stroke) within 6 months of screening
- Subjects with a history of myocardial infarction or unstable angina within 6 months of screening. Subjects should not have a planned coronary procedure during their participation in the study
- Subjects with acute or chronic congestive heart failure (New York Heart Association Class III \[moderate\] or Class IV \[severe\]) at screening
- Subjects with a history of more than mild restrictive or congestive cardiomyopathy uncontrolled by medication or implanted device
- Subjects with a history of life-threatening cardiac arrhythmias
- Subjects with a history of hemodynamically significant aortic or mitral valve disease
- Subjects with a history of 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 scleroderma renal crisis within 6 months of screening
- 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 (eg, epoprostenol, treprostinil, iloprost, and selexipag) within 8 weeks of screening
- Subjects who have initiated or had a dose change of any of the following within 2 weeks of screening: oral, topical, or intravenous (IV) vasodilators (eg, calcium channel blockers, phosphodiesterase-5 (PDE5) inhibitors \[eg, sildenafil, tadalafil, or vardenafil\], nitrates, and fluoxetine)
- Subjects with any history of acetaminophen intolerability (eg, allergic reaction to acetaminophen)
- Subjects with any malignancy that requires treatment during the study period, that has required treatment within 1 year of screening (including excision of skin cancer) 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)
- Subjects who have participated in ES-201 or ES-301 studies and were randomized and treated with study drug
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2021
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04040322
Start Date
October 14 2019
End Date
June 9 2021
Last Update
May 25 2025
Active Locations (30)
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1
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States, 85032
2
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
3
University of Arizona - Arthritis Research Center
Tucson, Arizona, United States, 85724
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048