A Phase 2 interventional study of Oral Ifetroban and Oral Placebo in Scleroderma, Diffuse, Scleroderma, Systemic and Scleroderma, Limited, sponsored by Cumberland Pharmaceuticals. Active, not recruiting at 13 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Cumberland Pharmaceuticals · Phase 2, Interventional, and Treatment
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).
This study is a randomized, placebo-controlled, double-blind phase 2 trial of patients with dcSSc or SSc-PAH. Twenty participants with SSc-PAH and 14 participants with dcSSc will be randomized to receive either oral ifetroban daily or matching placebo. Study participants will be treated for 12 months, followed by a 30-day follow-up period. The study will test whether ifetroban is safe and statistically superior to placebo in reducing the effects of their disease at month 12 and explore the ability of ifetroban to prevent or reverse progression in patients with early disease duration and reverse established disease in patients with longer disease duration.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
This study's planned enrollment of 34 is below the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →Cumberland Pharmaceuticals is the lead sponsor of 49 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diffuse Cutaneous Criterion:
1. Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria and dcSSc within 7 years following initial diagnosis as defined by the onset of the first non-Raynaud symptom.
SSc-PAH Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
Drug: Oral Ifetroban · Drug: Oral Placebo
Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
Drug: Oral Ifetroban · Drug: Oral Placebo
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Also known as: Ifetroban
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Also known as: Ifetroban
Incidence of adverse events (AEs) and Serious AEs (SAEs)
Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.
Time frame: 56 weeks
Change from baseline in forced vital capacity (FVC)
To determine if ifetroban improves pulmonary function in subjects with diffuse cutaneous SSc or SSc-PAH compared to placebo as measured by a change from baseline FVC.
Time frame: Baseline, 12, 26, and 52 weeks
Change from baseline in diffusion capacity for carbon monoxide (DLCO)
To determine if ifetroban improves pulmonary function in subjects with diffuse cutaneous SSc or SSc-PAH compared to placebo as measured by a change from baseline diffusion capacity for carbon monoxide (DLCO)
Time frame: Baseline, 12, 26, and 52 weeks
Change from baseline in the modified Rodnan skin score (mRSS)
The efficacy of treatment on skin fibrosis will be measured by changes from baseline in mRSS, a measure of skin thickness, at 52 weeks.
Time frame: Baseline, 12, 26, 39, and 52 weeks
Change from baseline in ventricular function as determined by cardiac MRI
Time frame: Baseline, 26, and 52 weeks
Change from baseline in ventricular function as determined by echocardiography
Time frame: Baseline, 26, and 52 weeks
Improve skin and peripheral vascular disease as measured by active digital ulcer count
Time frame: Baseline, 12, 26, 39, and 52 weeks
Improve skin and peripheral vascular disease as measured by the subject's self-assessment of pain in digits by a visual analog scale (VAS), if active digital ulcers are present.
Time frame: Baseline, 12, 26, 39, and 52 weeks
Change from baseline in blood biomarkers
Time frame: Baseline, 26, and 52 weeks
Change from baseline in skin biomarkers
Time frame: Baseline, 26, and 52 weeks
Change from baseline in erythrocyte sedimentation rate
Time frame: Baseline, 26, and 52 weeks
Change from baseline in subject-reported health status assessed by the Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: Baseline, 12, 26, 39, and 52 weeks
Change from baseline in subject health and disability measurements as assessed by the World Health Organization Disability Assessment Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline, 12, 26, 39, and 52 weeks
Change from baseline in subject-reported gastro-intestinal tract symptoms as assessed by the University of California, Los Angles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Tract (GIT) Questionnaire
Time frame: Baseline, 12, 26, 39, and 52 weeks
Change from baseline in subject-reported outcomes as assessed by the short-form health survey (SF-36)
Time frame: Baseline, 12, 26, 39, and 52 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ifetroban