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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Treatments: Ifetroban

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.