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Aurora Study

The Aurora Study

 

What is the purpose of the Aurora study?

The main purpose of this study is to evaluate the safety and effectiveness of the investigational study drug, iloprost, compared to placebo (which has no active ingredients) in decreasing the frequency and symptoms (pain, numbness, tingling, and discomfort) of symptomatic Raynaud’s phenomenon (RP) attacks in people with systemic sclerosis (SSc).

Who is conducting the study?

The study is being conducted by Eicos Sciences.

Who can take part in the study?

You may qualify to participate in the Aurora study if you meet basic study requirements:
  • are at least 18 years old
  • have a diagnosis of SSc
  • are experiencing frequent symptomatic (pain, numbness, tingling, and/or discomfort) RP attacks

What will happen during the study?

Please note that some, or all, of your study participation may take place at the study site, your home with a home healthcare professional, or at a local ambulatory infusion suite. Your study doctor will determine what is best for you and your study care.

Screening

The Screening Period is used to determine if you meet the requirements to enroll in the study. During this period, you will:
  • read and sign the consent form where you agree to participate in the study
  • attend your first study site visit (or complete the visit at home)
  • have health assessments and evaluations
  • enter information daily into an electronic participant diary (ePRO diary) about your symptomatic RP attacks, including:
    • the number of symptomatic RP attacks
    • the duration of the symptomatic RP attacks
    • the number of times you go outside
    • any time you take pain relief or anti-inflammatory medication for ANY reason, not only related to your RP attacks

If you have any trouble remembering the number or duration of your attacks, please consider keeping a log, journal, or record of your attacks to help you complete your daily diary entries.

A symptomatic RP attack, for this study, is defined as at least 1-color change of the finger(s) (blue, white, or red) associated with at least 1 symptom (pain, numbness, tingling, and/or discomfort of the finger[s]).

A symptomatic RP attack ends when the color (blue, white, or red) and symptoms (pain, numbness, tingling, and/or discomfort) return to how they were before the start of the attack.

You will be instructed by the study doctor/staff to record symptomatic RP attacks ONLY if you have color change AND symptoms. We realize that your fingers sometimes remain cold throughout the day, but this should not be recorded as a symptomatic RP attack.


Study Drug Administration

Once you complete Screening and are determined eligible to continue into the Study Drug Administration Period, you will:
  • be randomly assigned a study therapy with a 50% chance of receiving either the study drug, iloprost, or placebo (no active ingredients)
  • receive study therapy intravenously directly into a vein for 5 consecutive days
    • the 5 study drug infusion visits may last about 8 hours each
    • a caregiver may join you for study visits at the study site or at a local ambulatory infusion suite, if needed/ preferred and allowed at the site
  • follow the instructions you receive from the study doctor and study staff
  • continue entering information into the electronic participant diary every day about your symptomatic RP attacks and any pain relief or anti-inflammatory medication taken for ANY reason 

Post-Study Drug Administration Follow-up

After completing the Study Drug Administration Period, you will:
  • continue to enter information into the electronic participant diary every day about your symptomatic RP attacks and any pain relief or anti-inflammatory medication taken for ANY reason
  • be contacted by the study team twice via phone to check in on how you are feeling since receiving study drug
  • complete 1 follow-up visit

Learn more about the study drug, iloprost



 

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