Active, not recruiting
Phase 2
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
Condition(s) studied
Scleroderma, DiffuseScleroderma, SystemicScleroderma, LimitedSclerosis, Progressive SystemicSkin DiseasesConnective Tissue DiseasesPathologic ProcessesAutoimmune Diseases
Investigational drug(s) / intervention(s)
Oral Ifetroban: Subjects will be treated with oral ifetroban or placebo daily for 365 days
Oral Placebo: Subjects will be treated with oral ifetroban or placebo daily for 365 days
Study 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).
Eligibility
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.
Primary outcome measure(s)
- Incidence of adverse events (AEs) and Serious AEs (SAEs) — 56 weeks
Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.
Trial sites (13)
| Facility | City | Region | Status |
| The Universtity of Arizona Arthrtis Center |
Tucson |
Arizona |
|
| UCLA |
Los Angeles |
California |
|
| Cleveland Clinic - Florida |
Weston |
Florida |
|
| Johns Hopkins University |
Baltimore |
Maryland |
|
| Massachusetts General Hospital |
Boston |
Massachusetts |
|
| University of Nebraska Medical Center |
Omaha |
Nebraska |
|
| Hospital for Special Surgery |
New York |
New York |
|
| Thomas Jefferson University |
Philadelphia |
Pennsylvania |
|
| Medical University of South Carolina |
Charleston |
South Carolina |
|
| Baylor Research Institute |
Dallas |
Texas |
|
| PGIMER |
Chandigarh |
Chandigarh |
|
| KDH - Kokilaben Dhirubhai Ambani Hospital |
Mumbai |
Maharashtra |
|
| B. J. Government Medical College |
Pune |
Maharashtra |
|