New pill offers hope for fingers that turn white and blue in the cold
NCT ID NCT07112183
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an oral pill called treprostinil in 30 adults with severe Raynaud's phenomenon that hasn't improved with usual therapies. Raynaud's causes fingers and toes to change color and become painful when cold or stressed. Participants will take the pill three times daily for 26 weeks and track their daily symptoms to see if the medication reduces attack frequency and severity.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged ≥ 18 years 2. 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. 3. Patients with either: 1. Primary Raynaud's Phenomenon 2. 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 erythematosus (SLE), with diagnosis of the underlying rheumatic disease based on standard criteria. 4. 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 with no change in dose or frequency. 5. 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 6. If female of non-childbearing potential, meets either of the following criteria: 1. 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 years old and has been amenorrheic for \>5 years, the participant may be enrolled with an FSH \<25 mIU/mL after discussion with the PI. 2. Has a documented hysterectomy, bilaterial oophorectomy, or salpingectomy. Exclusion Criteria: 1. Uncontrolled hypertension, diabetes mellitus, acute coronary or cerebrovascular event within 3 months, history of sympathectomy 2. Smoking within 3 months or smoking cessation using nicotine products 3. History of alcohol or other substance abuse within the previous year 4. Subjects with diverticulosis confirmed via endoscopic evaluation of the sigmoid colon with at least three diverticula noted 5. Subjects with moderate to severe liver disease, Child Pugh Class B or C 6. Subjects currently taking any other prostacyclin. 7. Pregnant or breast feeding or considering pregnancy in next 4 months 8. 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 investigational biologic drug before the start of the screening period. 9. 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 investigator's discretion. 10. Hospitalization for any indication within 7 days before the start of screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
NOT_YET_RECRUITINGBoston, Massachusetts, 02115-6110, United States
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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