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Raynaud's DiseasePhase 4NCT07112183

Open Label Treprostinil Raynaud's Study

A Phase 4 study testing Oral treprostinil (UT-15C) sustained release tablets in people with Raynaud's Disease and Raynaud Phenomena, run by Brigham and Women's Hospital at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. It can be painful and cause numbness or tingling. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Raynaud's Disease, Raynaud Phenomena, Raynauds
What is being tested?
Oral treprostinil (UT-15C) sustained release tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
15 Oct 2025to 1 Mar 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

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

  • 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 erythematosus (SLE), with diagnosis of the underlying rheumatic disease based on standard criteria.
  • 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.
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  • 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 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.
  • Has a documented hysterectomy, bilaterial oophorectomy, or salpingectomy.

Who cannot join

  • 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
  • Subjects with diverticulosis confirmed via endoscopic evaluation of the sigmoid colon with at least three diverticula noted
  • Subjects with moderate to severe liver disease, Child Pugh Class B or C
  • Subjects currently taking any other prostacyclin.
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  • 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 investigational biologic drug before the start of the screening period.
  • 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.
  • Hospitalization for any indication within 7 days before the start of screening.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olivia G Vayer contact

6175259733

ovayer@bwh.harvard.edu

Ruth Marrero contact

6175259733

rmarrero@bwh.harvard.edu

United States2 sites, 2 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115-6110

    Aaron B Waxman, MD, PhD, 617-525-9733, abwaxman@bwh.harvard.edu

    B, 6175259733, abwaxman@bwh.harvard.edu

    Not yet recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Aaron Waxman, MD, PhD, 617-525-9733, ovayer@bwh.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: An Open Label Study to Assess Efficacy of Oral Treprostinil Titrated to 3.0mg Three Times Daily or Highest Tolerable Dose in 30 Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon Resistant to Standard Vasodilatory Therapy

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. It can be painful and cause numbness or tingling.

When participants have Raynaud's, blood vessels react too strongly to cold or stress. Fingers and toes may turn white (blood moves away from the area), blue (lack of oxygen), or red and feel painful or tingly when warming up. These episodes usually last from a few minutes to several hours.

Read more

There are two types of Raynaud's. Primary Raynaud's (also called Raynaud's disease) itself and isn't connected to other health problems. It's the most common type and affects mostly women under 30. Secondary Raynaud's (also called Raynaud's phenomenon) is caused by other diseases like lupus, scleroderma, or rheumatoid arthritis. This type tends to be more serious and may cause painful sores on fingertips called digital ulcers.

For mild cases, staying warm might be enough. But if symptoms are severe, participants doctor might prescribe various medications including calcium channel blockers - blood pressure medicines that help open blood vessels, or other vasodilators - medicines that widen blood vessels. About 40% of people with scleroderma develop painful sores on their fingertips called digital ulcers. These happen when there isn't enough blood flow to heal small injuries.

For severe cases with digital ulcers, doctors might use prostacyclin therapy - medicines that mimic a natural substance that opens blood vessels. Oral treprostinil is a newer pill form of prostacyclin therapy that helps improve blood flow. The investigators are conducting a research study testing whether oral treprostinil - a pill that mimics prostacyclin (a natural blood vessel opener) - can help people with severe Raynaud's that doesn't respond to usual treatments. This represents hope for better treatment options for people with the most challenging cases of this condition.

Being tested
Oral treprostinil (UT-15C) sustained release tablets
Keywords
Raynaud&#39;s, Raynaud's Disease, Raynaud's Phenomena, Connective Tissue Disease, Systemic Sclerosis
Medical subject headings
Raynaud Disease, Connective Tissue Diseases, Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral treprostinil (UT-15C) sustained release tabletsDrug

    30 patients with symptomatic primary or secondary Raynaud's phenomenon (RP) resistant to standard vasodilatory therapy will be enrolled. Prior to treatment, subjects will record each day for 42 days the number of RP attacks as well as the duration of each RP attack, considered to be baseline data. After the 6-week baseline run in, all subjects will receive oral treprostinil sustained release tablets. Dose escalations can occur every 48 hours in 0.125 mg increments. Subjects will be titrated as tolerated to a goal dose of 3mg three times daily over a 6-week period. Titration can be done as quickly as tolerated. Once at goal dose subjects will enter the 26-week treatment phase. Throughout the study (6-week titration - 26-week treatment phase) subjects will record each day the number of RP attacks.

Study groups in NCT07112183
Study groupRoleWhat they receive
An open label study to assess efficacy of oral treprostinil in patients with Raynaud'sExperimentalA single center open label study to assess efficacy of oral treprostinil titrated to a tolerable goal dose of 3.0 mg three times per day (TID) in 30 patients with symptomatic primary or secondary Raynaud's phenomenon resistant to standard vasodilatory therapy. Eligible subjects at the time of signing an informed consent will have a diagnosis of primary or secondary Raynaud's phenomenon. Once enrolled, subjects will enter a run in period and record each day for 42 days the number of RP attacks as well as the duration of each RP attack. Frequency and duration of RP recorded within 6-weeks before active treatment phase will be baseline data. After the run in period subjects will be titrated as tolerated to a goal dose of 3mg TID over a 6-week period. Throughout the study (6-week titration - 26-week treatment phase) subjects will record each day the number of RP attacks as well as the duration of each RP attack.
Receives: Drug: Oral treprostinil (UT-15C) sustained release tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Raynaud's Condition Score from baseline (6-week run in), comparing treprostinil treatment phase vs. baseline phase.

    Once enrolled, throughout the study (6-weeks before active treatment; 6-week titration; 26-week treatment phase) subjects will record each day the number of RP attacks as well as the duration of each RP attack.. Frequency and duration of RP recorded within 6-weeks before active treatment phase will be considered to be baseline data.

    Every day subjects will complete the Raynaud's Condition Score (RCS). The RCS is an 11-point numerical rating scale (0-10) where 0 = "no difficulty" and 10 = "extreme difficulty". Patients complete the scale daily, and the average scores are calculated. The scale asks patients to consider multiple factors when rating their difficulty, including the number and duration of Raynaud's attacks, symptoms such as pain, numbness, burning, and tingling, and how the condition affects their ability to use their hands and perform daily activities.

    Measured: 38 weeks

Secondary outcomes (1)

  1. Digital Ulcer Score

    Digital Ulcer Score (DUS) will be assessed at every 4-week visit, Weeks 4, 8, 12, 16, 20, 24 and 28. Minimum Value: 0; No theoretical maximum. Higher scores indicate worse outcomes (more severe digital ulcers). The DUS is calculated by assessing each individual ulcer and multiplying the depth of the ulcer (1 point for hyperkeratosis, 10 points for ulcer) by the diameter (1 point if <0.5 cm, 2 points for ≥0.5 cm). The total score is then calculated as the sum of all individual ulcer scores.

    Measured: 32 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start15 Oct 2025
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion1 Mar 2029 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
30 patients with symptomatic primary or secondary Raynaud's phenomenon (RP) resistant to standard vasodilatory therapy will be enrolled. Prior to treatment, subjects will record each day for 42 days the number of RP attacks as well as the duration of each RP attack, considered to be baseline data. After the 6-week baseline run in, all subjects will receive oral treprostinil sustained release tablets. Dose escalations can occur every 48 hours in 0.125 mg increments. Subjects will be titrated as tolerated to a goal dose of 3mg three times daily over a 6-week period. Titration can be done as quickly as tolerated. Once at goal dose subjects will enter the 26-week treatment phase. Throughout the study (6-week titration - 26-week treatment phase) subjects will record each day the number of RP attacks.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07112183
Sponsor's protocol ID
2025P001219
Status last verified
Mar 2026
First submitted
1 Aug 2025
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Maverakis E, Patel F, Kronenberg DG, Chung L, Fiorentino D, Allanore Y, Guiducci S, Hesselstrand R, Hummers LK, Duong C, Kahaleh B, Macgregor A, Matucci-Cerinic M, Wollheim FA, Mayes MD, Gershwin ME. International consensus criteria for the diagnosis of Raynaud's phenomenon. J Autoimmun. 2014 Feb-Mar;48-49:60-5. doi: 10.1016/j.jaut.2014.01.020. Epub 2014 Feb 1.

    PubMed 24491823

  • Shah AA, Schiopu E, Hummers LK, Wade M, Phillips K, Anderson C, Wise R, Boin F, Seibold JR, Wigley F, Rollins KD. Open label study of escalating doses of oral treprostinil diethanolamine in patients with systemic sclerosis and digital ischemia: pharmacokinetics and correlation with digital perfusion. Arthritis Res Ther. 2013 Apr 18;15(2):R54. doi: 10.1186/ar4216.

    PubMed 23597147

  • Milio G, Corrado E, Genova C, Amato C, Raimondi F, Almasio PL, Novo S. Iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis and the quality of life: a new therapeutic protocol. Rheumatology (Oxford). 2006 Aug;45(8):999-1004. doi: 10.1093/rheumatology/kel038. Epub 2006 Feb 16.

    PubMed 16484290

  • Roustit M, Blaise S, Allanore Y, Carpentier PH, Caglayan E, Cracowski JL. Phosphodiesterase-5 inhibitors for the treatment of secondary Raynaud's phenomenon: systematic review and meta-analysis of randomised trials. Ann Rheum Dis. 2013 Oct;72(10):1696-9. doi: 10.1136/annrheumdis-2012-202836. Epub 2013 Feb 20.

    PubMed 23426043

  • Denton CP, Hachulla E, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.

    PubMed 29193819

  • Garcia de la Pena Lefebvre P, Nishishinya MB, Pereda CA, Loza E, Sifuentes Giraldo WA, Roman Ivorra JA, Carreira P, Rua-Figueroa I, Pego-Reigosa JM, Munoz-Fernandez S. Efficacy of Raynaud's phenomenon and digital ulcer pharmacological treatment in systemic sclerosis patients: a systematic literature review. Rheumatol Int. 2015 Sep;35(9):1447-59. doi: 10.1007/s00296-015-3241-1. Epub 2015 Apr 1.

    PubMed 25824427

  • Costa E, Cunha-Santos F, Dourado E, Oliveira D, Falzon L, Romao V, Duarte AC, Cordeiro A, Santiago T, Sepriano A. Systematic literature review to inform the Portuguese recommendations for the management of Raynaud's phenomenon and digital ulcers in systemic sclerosis and other connective tissue diseases. ARP Rheumatol. 2024 Jul 1;3(Apr-Jun):128-144. doi: 10.63032/YHBL8967.

    PubMed 38306796

  • Khouri C, Lepelley M, Bailly S, Blaise S, Herrick AL, Matucci-Cerinic M, Allanore Y, Trinquart L, Cracowski JL, Roustit M. Comparative efficacy and safety of treatments for secondary Raynaud's phenomenon: a systematic review and network meta-analysis of randomised trials. Lancet Rheumatol. 2019 Dec;1(4):e237-e246. doi: 10.1016/S2665-9913(19)30079-7.

    PubMed 38229380

  • Flavahan NA, Flavahan S, Mitra S, Chotani MA. The vasculopathy of Raynaud's phenomenon and scleroderma. Rheum Dis Clin North Am. 2003 May;29(2):275-91, vi. doi: 10.1016/s0889-857x(03)00021-8.

    PubMed 12841295

  • Stjernbrandt A, Pettersson H, Lundstrom R, Liljelind I, Nilsson T, Wahlstrom J. Incidence, remission, and persistence of Raynaud's phenomenon in the general population of northern Sweden: a prospective study. BMC Rheumatol. 2022 Jul 21;6(1):41. doi: 10.1186/s41927-022-00272-0.

    PubMed 35858907

  • Maciejewska M, Sikora M, Maciejewski C, Alda-Malicka R, Czuwara J, Rudnicka L. Raynaud's Phenomenon with Focus on Systemic Sclerosis. J Clin Med. 2022 Apr 28;11(9):2490. doi: 10.3390/jcm11092490.

    PubMed 35566614

  • Curtiss P, Svigos K, Schwager Z, Lo Sicco K, Franks AG Jr. Part I: Epidemiology, pathophysiology, and clinical considerations of primary and secondary Raynaud's phenomenon. J Am Acad Dermatol. 2024 Feb;90(2):223-234. doi: 10.1016/j.jaad.2022.06.1199. Epub 2022 Jul 7.

    PubMed 35809798

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral treprostinil (UT-15C) sustained release tablets in people with Raynaud's Disease and Raynaud Phenomena, run by Brigham and Women's Hospital at 2 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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olivia G Vayer (6175259733, ovayer@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Raynaud's Condition Score from baseline (6-week run in), comparing treprostinil treatment phase vs. baseline phase. (time frame: 38 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07112183, which also lists 12 linked publications.

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 24 Mar 2026.

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