Home › Trials › NCT02682511

Using Ifetroban to treat systemic sclerosis and related pulmonary hypertension

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)

Phase 2 Interventional Cumberland Pharmaceuticals · NCT02682511

This study is testing if the medication ifetroban can help people with systemic sclerosis or related lung high blood pressure feel better and slow down their disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment34 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorCumberland Pharmaceuticals Industry-sponsored
Drugs / interventionsrituximab, prednisone
Locations17 sites (Tucson, Arizona and 16 other locations)
Trial IDNCT02682511 on ClinicalTrials.gov

What this trial studies

This phase 2 multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the safety and efficacy of oral ifetroban in patients with diffuse cutaneous systemic sclerosis (dcSSc) or systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH). A total of 34 participants will be randomly assigned to receive either ifetroban or a placebo for 12 months, followed by a 30-day follow-up. The study will assess whether ifetroban can significantly reduce disease effects compared to placebo and explore its potential to prevent or reverse disease progression in patients with varying disease durations.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with diffuse cutaneous systemic sclerosis or systemic sclerosis-associated pulmonary arterial hypertension within specific criteria.

Not a fit: Patients with systemic sclerosis sine scleroderma or those outside the age range of 18 to 80 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from systemic sclerosis and its associated complications.

How similar studies have performed: While this approach is novel for this specific condition, previous studies have explored similar treatments for systemic sclerosis with varying degrees of success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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:

1. 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
2. Stable oral therapy for PAH for at least 30 days (monotherapy or combination)
3. New York Heart Association (NYHA) Class I-III Heart Failure

Exclusion Criteria:

1. Have a diagnosis of systemic sclerosis sine scleroderma;
2. Be less than 18 years of age or greater than or equal to 80 years of age;
3. Be pregnant, nursing, or planning to become pregnant;
4. Current or planned treatment with prostanoid therapy;
5. Current or planned treatment with pirfenidone;
6. Use of rituximab in the last 3 months;
7. Use of mycophenolic acid (Myfortic, CellCept) at a stable dose for less than 3 months;
8. Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent;
9. Significant lung disease, defined as FVC \< 50% predicted or DLCO \<40% predicted;
10. Significant kidney disease, defined as Glomerular Filtration Rate (GFR) \< 60 ml/min;
11. Have moderate or severe hepatic impairment;
12. Contraindication to MRI (e.g., implanted magnetic material, claustrophobia);
13. Known hypersensitivity to gadolinium;
14. Any cause of pulmonary hypertension other than World Health Organization (WHO) Group I associated with SSc;
15. Use of aspirin \> 81 mg per day in the last two weeks;
16. Use of warfarin, heparin or other anticoagulants in the last 30 days;
17. Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias;
18. Have a history of allergy or hypersensitivity to ifetroban;
19. Have taken investigational drugs within 30 days before study treatment administration;
20. 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;
21. Be otherwise unsuitable for the study, in the opinion of the investigator.

Where this trial is running

Tucson, Arizona and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Scleroderma, DiffuseScleroderma, SystemicScleroderma, LimitedSclerosis, Progressive SystemicSkin DiseasesConnective Tissue DiseasesPathologic ProcessesAutoimmune Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.