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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo IV infusion | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 8 - Day 21 will be compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wade Benton, Pharm D | Civibio Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix | Arizona | 85032 | United States | ||
| Pacific Arthritis Care Center of Los Angeles |
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In this study 41 participants with Systemic Sclerosis (SSc) were screened.34 participants who had at least 10 symptomatic Raynaud's phenomenon (RP) attacks on the 5-day eligibility period were randomized on to the study: 17 to the placebo arm and 17 to the Iloprost arm.
The study was initiated on 07 March 2019 and completed on 06 August 2019. It was conducted in 16 sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Placebo IV infusion: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2019 | Apr 23, 2025 |
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| Iloprost Injection, for intravenous use | Drug | 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. |
|
| Los Angeles |
| California |
| 90045 |
| United States |
| Stanford University Medical Center | Palo Alto | California | 94305 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Georgetown University Medical Center - Department of Rheumatology | Washington D.C. | District of Columbia | 20007 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21224 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-5422 | United States |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The University of Toledo Medical Center (UTMC) - Ruppert Health Center | Toledo | Ohio | 43614 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | United States |
| University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics | Houston | Texas | 77030 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Arthritis Northwest Rheumatology PLLC | Spokane | Washington | 99204 | United States |
| FG001 | 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. Iloprost Injection, for intravenous use: 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Placebo IV infusion: 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. |
| BG001 | 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. Iloprost Injection, for intravenous use: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Phosphodiesterase inhibitor at baseline | Number | n (%) |
| ||||||||||||||||
| Weekly frequency of symptomatic RP attacks at baseline | Median | Standard Deviation | no. of attacks |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The modified Intention-to-Treat (mITT) Population was defined as all randomized subjects who initiated infusion of study drug. | Posted | Least Squares Mean | 95% Confidence Interval | Number of RP attacks per week | Day 8 - Day 21 will be compared to baseline |
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|
Day 1 to Day 35
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Placebo IV infusion: 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. | 0 | 17 | 0 | 17 | 14 | 17 |
| EG001 | 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. Iloprost Injection, for intravenous use: 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. | 0 | 17 | 0 | 17 | 17 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Vessel puncture site pruritus | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Infected skin ulcer | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Non-systematic Assessment |
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| Breast discharge | Reproductive system and breast disorders | MedDRA 21.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Executive Officer | CiVi Biopharma, Inc. | 301-968-2390 | sj@civibio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2019 | Apr 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D011928 | Raynaud Disease |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
|
| Change in the Weekly Frequency of Symptomatic Raynaud's Phenomenon Attacks From Baseline to the Double-Blind Endpoint Using Nonparametric Analysis - Modified Intent-to-Treat Population. Treatment comparison of change versus placebo. | Wilcoxon (Mann-Whitney) | 0.9729 | Median Difference (Final Values) | -0.24 | 2-Sided | 95 | -9.97 | 9.32 | Superiority |