AURORA is a Phase 3, multicenter, double-blind randomized clinical trial designed to evaluate efficacy of IV iloprost compared to placebo on the change from baseline on symptomatic digital ischemic episodes, as measured by weekly frequency of RP attacks, in subjects with Systemic Sclerosis.
PRIMARY ENDPOINT is the change in weekly frequency of symptomatic RP attacks from baseline.
SECONDARY ENDPOINTS: Severity of RP attacks as determined by symptoms, duration of attacks and percentage of patients who reach a pre-defined symptomatic response.
Key Study Inclusion Criteria:
- Male or female subjects ≥18 years of age
- Diagnosis of SSc as defined by the 2013 ACR/EULAR criteria
- Diagnosis or history of RP, self-reported or reported by a physician, with ≥2-phase color change in finger(s) of pallor, cyanosis, and/or reactive hyperemia in response to cold exposure or emotion
- ≥10 symptomatic RP attacks, documented in ePRO diary, occurring over ≥3 separate days of 3-to-5-day eligibility period
For Complete Study Details, Please View the Study Listing on: www.ClinicalTrials.gov Identifier: NCT04040322
If you are a Systemic Sclerosis patient and would like to learn more about the AURORA study, please visit the Study website on: https://www.aurorasscstudy.com/