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

About

Brief 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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

80 Years

Inclusion Criteria:

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

Exclusion Criteria:

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.