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

NCT ID: NCT02682511

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2026-05-31

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).

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Patients with dcSSc

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

Group Type: EXPERIMENTAL

Oral Ifetroban

Intervention Type: DRUG

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

Oral Placebo

Intervention Type: DRUG

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

Patients with SSc-PAH

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

Group Type: EXPERIMENTAL

Oral Ifetroban

Intervention Type: DRUG

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

Oral Placebo

Intervention Type: DRUG

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

Interventions

Oral Ifetroban

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

Intervention Type: DRUG

Oral Placebo

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

Intervention Type: DRUG

Other Intervention Names

Ifetroban; Ifetroban

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan Brittain, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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

Countries

United States; India

Other Identifiers

CPI-IFE-004

Identifier Type: -

Identifier Source: org_study_id