Scleroderma, DiffusePhase 2NCT02682511
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
A Phase 2 study testing Oral Ifetroban in people with Scleroderma, Diffuse and Scleroderma, Systemic, run by Cumberland Pharmaceuticals at 13 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited
- What is being tested?
- Oral Ifetroban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jan 2017to Sep 2026
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Adults fulfilling the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria with confirmed SSc-PAH (limited or dcSSc) confirmed via previous cardiac catheterization
- Stable oral therapy for PAH for at least 30 days (monotherapy or combination)
- New York Heart Association (NYHA) Class I-III Heart Failure
Who cannot join
- Have a diagnosis of systemic sclerosis sine scleroderma;
- Be less than 18 years of age or greater than or equal to 80 years of age;
- Be pregnant, nursing, or planning to become pregnant;
- Current or planned treatment with prostanoid therapy;
- Current or planned treatment with pirfenidone;
- Use of rituximab in the last 3 months;
Show all 21Show fewer
- Use of mycophenolic acid (Myfortic, CellCept) at a stable dose for less than 3 months;
- Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent;
- Significant lung disease, defined as FVC < 50% predicted or DLCO <40% predicted;
- Significant kidney disease, defined as Glomerular Filtration Rate (GFR) < 60 ml/min;
- Have moderate or severe hepatic impairment;
- Contraindication to MRI (e.g., implanted magnetic material, claustrophobia);
- Known hypersensitivity to gadolinium;
- Any cause of pulmonary hypertension other than World Health Organization (WHO) Group I associated with SSc;
- Use of aspirin > 81 mg per day in the last two weeks;
- Use of warfarin, heparin or other anticoagulants in the last 30 days;
- Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias;
- Have a history of allergy or hypersensitivity to ifetroban;
- Have taken investigational drugs within 30 days before study treatment administration;
- Inability to understand the requirements of the study, inability to understand spoken English and abide by the study restrictions and to return for the required treatments and assessments;
- Be otherwise unsuitable for the study, in the opinion of the investigator.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29403
Baylor Research Institute
Dallas, Texas, 75204-651
UCLA
Los Angeles, California, 90095-1670
Hospital for Special Surgery
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
The Universtity of Arizona Arthrtis Center
Tucson, Arizona, 85724
Cleveland Clinic - Florida
Weston, Florida, 33331
India3 sites
PGIMER
Chandigarh, Chandigarh, 160012
KDH - Kokilaben Dhirubhai Ambani Hospital
Mumbai, Maharashtra, 400053
B. J. Government Medical College
Pune, Maharashtra, 411001
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)
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).
Read the detailed description
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.
- Conditions
- Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited, Sclerosis, Progressive Systemic, Skin Diseases, Connective Tissue Diseases
- Being tested
- Oral Ifetroban, Oral Placebo
- Keywords
- Ifetroban, Scleroderma, Systemic Sclerosis
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited, Skin Diseases, Connective Tissue Diseases, Pathologic Processes, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral IfetrobanDrug
Also called Ifetroban
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Oral PlaceboDrug
Also called Ifetroban
Subjects will be treated with oral ifetroban or placebo daily for 365 days
| Study group | Role | What they receive |
|---|---|---|
| Patients with dcSSc | Experimental | Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days Receives: Drug: Oral Ifetroban; Drug: Oral Placebo |
| Patients with SSc-PAH | Experimental | Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days Receives: Drug: Oral Ifetroban; Drug: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 weeks
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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.
Measured: Baseline, 12, 26, 39, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, DiffuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evan Brittain, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682511
- Sponsor's protocol ID
- CPI-IFE-004
- Status last verified
- Aug 2026
- First submitted
- 8 Feb 2016
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)
- ClinicalTrials.gov ID
- NCT02682511
- Acronym / sponsor ID
- CPI-IFE-004
- Conditions
- Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited, Sclerosis, Progressive Systemic, Skin Diseases, Connective Tissue Diseases
- Keywords
- Ifetroban, Scleroderma, Systemic Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with dcSSc | Experimental | Drug: Oral Ifetroban, Drug: Oral PlaceboPatients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days |
| Patients with SSc-PAH | Experimental | Drug: Oral Ifetroban, Drug: Oral PlaceboPatients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Adults fulfilling the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria with confirmed SSc-PAH (limited or dcSSc) confirmed via previous cardiac catheterization
- Stable oral therapy for PAH for at least 30 days (monotherapy or combination)
- New York Heart Association (NYHA) Class I-III Heart Failure
Key exclusion criteria (21 listed)
- Have a diagnosis of systemic sclerosis sine scleroderma;
- Be less than 18 years of age or greater than or equal to 80 years of age;
- Be pregnant, nursing, or planning to become pregnant;
- Current or planned treatment with prostanoid therapy;
- Current or planned treatment with pirfenidone;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral IfetrobanAlso: IfetrobanSubjects will be treated with oral ifetroban or placebo daily for 365 days | Drug | Patients with SSc-PAH, Patients with dcSSc |
| Oral PlaceboAlso: IfetrobanSubjects will be treated with oral ifetroban or placebo daily for 365 days | Drug | Patients with SSc-PAH, Patients with dcSSc |
Primary outcome
Incidence of adverse events (AEs) and Serious AEs (SAEs)
Time frame: 56 weeks
Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.
3 secondary outcomes
Change from baseline in forced vital capacity (FVC)
Time frame: Baseline, 12, 26, and 52 weeks
Change from baseline in diffusion capacity for carbon monoxide (DLCO)
Time frame: Baseline, 12, 26, and 52 weeks
Change from baseline in the modified Rodnan skin score (mRSS)
Time frame: Baseline, 12, 26, 39, and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Scleroderma, Diffuse
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
RecruitingPhase 1
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Systemic Lupus Erythematosus, Systemic Sclerosis
Not yet recruitingObservational study
A Clinical Study on Systemic Sclerosis and the Validation of French-language Questionnaires Assessing Disability, Quality of Life, and Disease Status.
Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Brittain, MD principal investigator
Vanderbilt University Medical Center
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Ifetroban in people with Scleroderma, Diffuse and Scleroderma, Systemic, run by Cumberland Pharmaceuticals at 13 sites in 2 countries.
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 6 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, India. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and Serious AEs (SAEs) (time frame: 56 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.