Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Civi Biopharma, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
