Raynaud Phenomenon Secondary to Systemic SclerosisPhase 2NCT03867097
Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
A Phase 2 study testing Iloprost Injection, for intravenous use in people with Raynaud Phenomenon Secondary to Systemic Sclerosis, run by Civi Biopharma, Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Raynaud Phenomenon Secondary to Systemic Sclerosis
- What is being tested?
- Iloprost Injection, for intravenous use
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 16 sitesUnited States
- Study dates
- 7 Mar 2019to 6 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- Subjects with a history of myocardial infarction or unstable angina within 6 months of screening
- Subjects with acute or chronic congestive heart failure
- Subjects with a history of life-threatening cardiac arrhythmias
- Subjects with a history of hemodynamically significant aortic or mitral valve disease
- Subjects with more than mild restrictive or congestive cardiomyopathy uncontrolled by medication or implanted device.
- Subjects with known pulmonary hypertension, pulmonary arterial hypertension, or pulmonary veno-occlusive disease
- Subjects with a history of significant restrictive lung disease defined as forced vital capacity <45% predicted and diffusing capacity of the lungs for carbon monoxide <40% predicted (uncorrected for hemoglobin).
- Subjects with a history of cervical or digital sympathectomy
- Subjects with scleroderma renal crisis
- Subjects with a concomitant life-threatening disease with a life expectancy <12 months
- Subjects who have a clinically significant disorder, that in the opinion of the Investigator, could contraindicate the administration of study drug, affect compliance, interfere with study evaluations, or confound the interpretation of study results
- Subjects who have taken or are currently taking any parenteral, inhaled, or oral prostacyclin or prostacyclin receptor agonists
- Subjects must not initiate dosing of oral, topical, or intravenous (IV) vasodilators or if currently receiving any vasodilator must have been stably medicated
- Subjects with any history of acetaminophen intolerability
- Subjects with any malignancy that requires treatment during the study period, that has required treatment within 1 year of screening, or that is currently not in remission.
- Subjects who have used any investigational medication or device for any indication within 30 days or 5 half-lives (whichever is longer)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Michigan
Ann Arbor, Michigan, 48109-5422
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
Houston, Texas, 77030
Pacific Arthritis Care Center of Los Angeles
Los Angeles, California, 90045
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Hospital for Special Surgery
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Stanford University Medical Center
Palo Alto, California, 94305
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
University of California San Francisco
San Francisco, California, 94143
Virginia Mason Medical Center
Seattle, Washington, 98101
Arthritis Northwest Rheumatology PLLC
Spokane, Washington, 99204
The University of Toledo Medical Center (UTMC) - Ruppert Health Center
Toledo, Ohio, 43614
Georgetown University Medical Center - Department of Rheumatology
Washington D.C., District of Columbia, 20007
About this study
Official title: 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
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.
- Being tested
- Placebo IV infusion, Iloprost Injection, for intravenous use
- Keywords
- systemic sclerosis, raynaud phenomenon
- Medical subject headings
- Scleroderma, Systemic, Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo IV infusion |
| Iloprost Injection, for intravenous use | Active comparator | 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. Receives: Drug: Iloprost Injection, for intravenous use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Frequency of Symptomatic RP Attacks
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.
Measured: Day 8 - Day 21 will be compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start7 Mar 2019
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Raynaud Phenomenon Secondary to Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Civi Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wade Benton, Pharm D, Study director, Civibio Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867097
- Sponsor's protocol ID
- ES-201
- Status last verified
- May 2025
- First submitted
- 6 Mar 2019
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03867097
- Acronym / sponsor ID
- ES-201
- Keywords
- systemic sclerosis, raynaud phenomenon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Civi Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo IV infusionSubjects 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. |
| Iloprost Injection, for intravenous use | Active comparator | Drug: Iloprost Injection, for intravenous useSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo IV infusionStudy 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. | Drug | Placebo |
| Iloprost Injection, for intravenous useStudy 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. | Drug | Iloprost Injection, for intravenous use |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Raynaud Phenomenon Secondary to Systemic Sclerosis
Not yet recruitingPhase 3
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
Not yet recruitingPhase 2
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Raynaud's Phenomenon Secondary to Systemic Sclerosis
RecruitingPhase 4
Open Label Treprostinil Raynaud's Study
Raynaud's Disease, Raynaud Phenomena
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wade Benton, Pharm D study director
Civibio Pharma, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iloprost Injection, for intravenous use in people with Raynaud Phenomenon Secondary to Systemic Sclerosis, run by Civi Biopharma, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frequency of Symptomatic RP Attacks (time frame: Day 8 - Day 21 will be compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.