Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited, Sclerosis, Progressive Systemic, Skin Diseases, Connective Tissue Diseases, Pathologic Processes, Autoimmune Diseases

In brief

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).

Key facts

Study ID

NCT02682511

Run by

Cumberland Pharmaceuticals

People needed

34

Starts

2017-01-01

Expected to finish

2026-08-01

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diffuse Cutaneous Criterion:
• 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

You may not qualify if…

• 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;
• 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.

Where it is running

• The Universtity of Arizona Arthrtis Center — Tucson, Arizona, United States
• UCLA — Los Angeles, California, United States
• Cleveland Clinic - Florida — Weston, Florida, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hospital for Special Surgery — New York, New York, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor Research Institute — Dallas, Texas, United States
• PGIMER — Chandigarh, Chandigarh, India
• KDH - Kokilaben Dhirubhai Ambani Hospital — Mumbai, Maharashtra, India
• B. J. Government Medical College — Pune, Maharashtra, India

Full record on ClinicalTrials.gov

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