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



Status:Recruiting
Conditions:Skin Cancer, High Blood Pressure (Hypertension), Skin and Soft Tissue Infections, Infectious Disease, Neurology, Orthopedic, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Neurology, Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:11/18/2018
Start Date:January 2017
End Date:February 2020
Contact:Byron Kaelin, RN, BSHS
Email:bkaelin@cumberlandpharma.com
Phone:615-255-0068

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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)

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).

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.

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.
We found this trial at
7
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Laura Hummer, MD
Phone: 410-550-8582
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Flavia Castelino, MD
Phone: 617-724-2792
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Evan Brittain, MD
Phone: 615-875-8937
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Richard Silver, MD
Phone: 843-792-5290
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Hialeah, Florida 33012
Principal Investigator: Odalys P Frontela, MD
Phone: 786-360-3750
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Suzanne Kafaja, MD
Phone: 310-825-9682
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Jessica Gordon, MD
Phone: 212-774-7194
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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