Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Scle… (NCT04040322) | Clinical Trial Compass
CompletedPhase 3
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
United States198 participantsStarted 2019-10-14
Plain-language 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 episodes in subjects with systemic sclerosis.
Who can participate
Age range18 Years
SexALL
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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 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 Criteria:
* 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 cervica…
What they're measuring
1
Change in Frequency of Symptomatic RP Attacks
Timeframe: From baseline (Day 10 to Day 25 of screening period) to the end ofthe efficacy follow-up (Day 8 to Day 21).