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

Description

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).

Conditions

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

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Scleroderma, Diffuse
Intervention / Treatment

-

Contacts and Locations

Tucson

The Universtity of Arizona Arthrtis Center, Tucson, Arizona, United States, 85724

Los Angeles

UCLA, Los Angeles, California, United States, 90095-1670

Hialeah

New Life Medical Research Center, Inc., Hialeah, Florida, United States, 33012

Weston

Cleveland Clinic - Florida, Weston, Florida, United States, 33331

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21224

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Boston University School of Medicine, Boston, Massachusetts, United States, 02118

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

New York

Hospital for Special Surgery, New York, New York, United States, 10021

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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
  • 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cumberland Pharmaceuticals,

Evan Brittain, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2025-12