A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Pilot Study Evaluating Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis
Overview
- Phase
- Phase 2
- Intervention
- Placebo IV infusion
- Conditions
- Raynaud Phenomenon Secondary to Systemic Sclerosis
- Sponsor
- Civi Biopharma, Inc.
- Enrollment
- 34
- Locations
- 16
- Primary Endpoint
- Change in Frequency of Symptomatic RP Attacks
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the effect of iloprost on the symptomatic relief of Raynaud's Phenomenon attacks in subjects with symptomatic Raynaud's Phenomenon secondary to Systemic Sclerosis.
Investigators
Eligibility Criteria
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
- •Subjects must have a diagnosis or history of Raynaud's Phenomenon
- •Subjects must have a minimum of 10 symptomatic Raynaud's Phenomenon attacks
- •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 \<30 mL/min/1.73 m2
- •Subjects with Child-Pugh Class B or Class C liver disease or an alanine aminotransferase and/or aspartate aminotransferase value \>3 × the upper limit of normal at screening.
- •Subjects with gangrene, digital ulcer infection, or requirement of cervical or digital sympathectomy
- •Subjects with intractable diarrhea or vomiting
- •Subjects with a risk of clinically significant bleeding events including those with coagulation or platelet disorders
- •Subjects with a history of major trauma or hemorrhage
- •Subjects with clinically significant chronic intermittent bleeding such as active gastric antral vascular ectasia or active peptic ulcer disease
- •Subjects who have had any cerebrovascular events
Arms & Interventions
Placebo
Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line. Study drug will be initiated at a starting dose 0.5 ng/kg/min up to 2.0 ng/kg/min.
Intervention: Placebo IV infusion
Iloprost Injection, for intravenous use
Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line. Study drug will be initiated at a starting dose 0.5 ng/kg/min up to 2.0 ng/kg/min.
Intervention: Iloprost Injection, for intravenous use
Outcomes
Primary Outcomes
Change in Frequency of Symptomatic RP Attacks
Time Frame: Day 8 - Day 21 will be compared to baseline
The primary efficacy parameter is the change in the weekly frequency of symptomatic RP attacks from baseline. The baseline weekly frequency of symptomatic RP attacks was defined as the average number of weekly symptomatic RP attacks that occurred during the 10- to 25-day baseline ePRO diary completion period. The double-blind endpoint weekly frequency of symptomatic RP attacks was defined as the average number of weekly symptomatic RP attacks that occurred during Days 8 to 21, inclusive.