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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02682511
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cumberland Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Evan Brittain, MD
Principal Investigator Affiliation	Vanderbilt University Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	India, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited, Sclerosis, Progressive Systemic, Skin Diseases, Connective Tissue Diseases, Pathologic Processes, Autoimmune Diseases

Additional Details

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.

Arms & Interventions

Arms

Experimental: Patients with dcSSc

Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days

Experimental: Patients with SSc-PAH

Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days

Interventions

Drug: - Oral Ifetroban

Subjects will be treated with oral ifetroban or placebo daily for 365 days

Drug: - Oral Placebo

Subjects will be treated with oral ifetroban or placebo daily for 365 days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tucson, Arizona

Status

Recruiting

Address

The Universtity of Arizona Arthrtis Center

Tucson, Arizona, 85724

Site Contact

Jazmin Dagnino

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