CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 198 enrolled
Drug / intervention
Placebo IV infusion +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04040322
NCT04040322Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study)

Civi Biopharma, Inc.·interventional·Posted Jul 31, 2019·Updated May 25, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo IV infusion and Iloprost Injection, for intravenous use for Raynaud's Phenomenon Secondary to Systemic Sclerosis. Completed, enrolled 198 participants across 30 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRaynaud's Phenomenon Secondary to Systemic Sclerosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 31, 2019
Enrollment StartOct 14, 2019
Primary CompletionJun 9, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.9 years ago

Interventions

Placebo IV infusiondrug

Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.

Iloprost Injection, for intravenous usedrug

Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.