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AURORA

Condition: Systemic sclerosis

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • Diagnosis of systemic sclerosis
  • Diagnosis or history of Raynaud’s phenomenon 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

Key Exclusion Criteria

  • Pregnant or breastfeeding prior to study group assignment
  • Systolic blood pressure <85 mmHg (sitting position) at screening
  • Estimated glomerular filtration rate <15 mL/min/1.73 m2 at screening

Full Study Name

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (IRB no. 00000961)

Summary

This study focuses on individuals who have been diagnosed with systemic sclerosis (SSc) and are experiencing symptomatic digital ischemic episodes. Digital ischemic episodes are the most common indicator of vascular abnormalities in SSc. Most people with SSc also have symptomatic Raynaud’s phenomenon (RP) attacks, which are caused by blood vessels in the hands and fingers that overreact to cold temperatures or stress and can result in pain, numbness, tingling, discomfort, and discoloration of the fingers.
 
The purpose of this study is to evaluate the investigational use of a drug called iloprost for the treatment of symptomatic RP attacks in people with SSc. Participants will be randomly assigned to receive either iloprost or placebo (inactive substance). Researchers will evaluate the safety and tolerability of iloprost and aim to determine whether the drug has an effect on how often symptomatic RP attacks occur. Additionally, the study will examine participants’ overall improvement in symptomatic RP attacks, as well as assess overall benefits compared to side effects.

Principal Investigator

Francesco Boin, MD

Contact
Bonnie Paul
Phone: 310-423-2422
Email: bonnie.paul@cshs.org