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New treatment option for Raynaud's Disease
Official title Open Label Treprostinil Raynaud's Study
ClinicalTrials.gov ID: NCT07112183
What this study is testing
What is Oral treprostinil (UT-15C) sustained release tablets?
Oral treprostinil (UT-15C) sustained release tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for raynaud's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Raynaud's phenomenon is a condition where the blood vessels in participants fingers and toes get too narrow when cold or stressed. This makes participants fingers and toes change colors - they might turn white, then blue, and finally red as blood flow returns.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged ≥ 18 years
- Active Raynaud's Phenomenon defined as patients with refractory RP having four or more RP attacks per week in the 4 weeks before inclusion in the...
- Patients with either:
- Primary Raynaud's Phenomenon
- Patients with Raynaud's secondary to connective tissue diseases (including scleroderma (SSc), limited scleroderma (CREST), mixed connective tissue...
You likely can't join if
- Uncontrolled hypertension, diabetes mellitus, acute coronary or cerebrovascular event within 3 months, history of sympathectomy
- Smoking within 3 months or smoking cessation using nicotine products
- History of alcohol or other substance abuse within the previous year
- people with diverticulosis confirmed via endoscopic evaluation of the sigmoid colon with at least three diverticula noted
- people with moderate to severe liver disease, Child Pugh Class B or C
- people currently taking any other prostacyclin.
See the full eligibility criteria
- Patients aged ≥ 18 years
- Active Raynaud's Phenomenon defined as patients with refractory RP having four or more RP attacks per week in the 4 weeks before inclusion in the study.
- Patients with either:
- Primary Raynaud's Phenomenon
- Patients with Raynaud's secondary to connective tissue diseases (including scleroderma (SSc), limited scleroderma (CREST), mixed connective tissue disease (MCTD), primary Sjogren's syndrome (SS), systemic lupus...
- If patients are on phosphodiesterase inhibitors (sildenafil, tadalafil or vardenafil), endothelin antagonists, alpha adrenergic antagonists, or calcium channel blockers, their dose must be stable, defined as 3-months...
- If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol
- If female of non-childbearing potential, meets either of the following criteria:
- Is in a postmenopausal state defined as no menses for 12 months without an alternative medical cause and follicle-stimulating hormone (FSH) level consistent with postmenopause (\>25 mIU/mL). If a participant is \>60...
- Has a documented hysterectomy, bilaterial oophorectomy, or salpingectomy.
- Uncontrolled hypertension, diabetes mellitus, acute coronary or cerebrovascular event within 3 months, history of sympathectomy
- Smoking within 3 months or smoking cessation using nicotine products
- History of alcohol or other substance abuse within the previous year
- people with diverticulosis confirmed via endoscopic evaluation of the sigmoid colon with at least three diverticula noted
- people with moderate to severe liver disease, Child Pugh Class B or C
- people currently taking any other prostacyclin.
- Pregnant or breast feeding or considering pregnancy in next 4 months
- Was dosed in any clinical research study evaluating another investigational drug (including biologics) or therapy (including specific immunotherapy) within 30 days or 5 half-lives (whichever is longer) of an...
- Any serious chronic, and/or unstable pre-existing medical, surgical, psychiatric or other condition that could interfere with the participant's safety, obtaining informed consent, or compliance with study procedures per...
- Hospitalization for any indication within 7 days before the start of screening.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.