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

This study is currently recruiting participants.
Verified November 2017 by Cumberland Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02682511
First Posted: February 15, 2016
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
  Purpose
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).

Condition Intervention Phase
Scleroderma, Diffuse Scleroderma, Systemic Scleroderma, Limited Sclerosis, Progressive Systemic Skin Diseases Connective Tissue Diseases Pathologic Processes Autoimmune Diseases Drug: Oral Ifetroban Drug: Oral Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) and Serious AEs (SAEs) [ Time Frame: 56 weeks ]
    Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.


Secondary Outcome Measures:
  • Change from baseline in forced vital capacity (FVC) [ Time Frame: Baseline, 12, 26, and 52 weeks ]
    To determine if ifetroban improves pulmonary function in subjects with diffuse cutaneous SSc or SSc-PAH compared to placebo as measured by a change from baseline FVC.

  • Change from baseline in diffusion capacity for carbon monoxide (DLCO) [ Time Frame: Baseline, 12, 26, and 52 weeks ]
    To determine if ifetroban improves pulmonary function in subjects with diffuse cutaneous SSc or SSc-PAH compared to placebo as measured by a change from baseline diffusion capacity for carbon monoxide (DLCO)

  • Change from baseline in the modified Rodnan skin score (mRSS) [ Time Frame: Baseline, 12, 26, 39, and 52 weeks ]
    The efficacy of treatment on skin fibrosis will be measured by changes from baseline in mRSS, a measure of skin thickness, at 52 weeks.


Other Outcome Measures:
  • Change from baseline in ventricular function as determined by cardiac MRI [ Time Frame: Baseline, 26, and 52 weeks ]
  • Change from baseline in ventricular function as determined by echocardiography [ Time Frame: Baseline, 26, and 52 weeks ]
  • Improve skin and peripheral vascular disease as measured by active digital ulcer count [ Time Frame: Baseline, 12, 26, 39, and 52 weeks ]
  • Improve skin and peripheral vascular disease as measured by the subject's self-assessment of pain in digits by a visual analog scale (VAS), if active digital ulcers are present. [ Time Frame: Baseline, 12, 26, 39, and 52 weeks ]
  • Change from baseline in blood biomarkers [ Time Frame: Baseline, 26, and 52 weeks ]
  • Change from baseline in skin biomarkers [ Time Frame: Baseline, 26, and 52 weeks ]
  • Change from baseline in erythrocyte sedimentation rate [ Time Frame: Baseline, 26, and 52 weeks ]
  • Change from baseline in subject-reported health status assessed by the Scleroderma Health Assessment Questionnaire (SHAQ) [ Time Frame: Baseline, 12, 26, 39, and 52 weeks ]
  • Change from baseline in subject health and disability measurements as assessed by the World Health Organization Disability Assessment Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: Baseline, 12, 26, 39, and 52 weeks ]
  • Change from baseline in subject-reported gastro-intestinal tract symptoms as assessed by the University of California, Los Angles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Tract (GIT) Questionnaire [ Time Frame: Baseline, 12, 26, 39, and 52 weeks ]
  • Change from baseline in subject-reported outcomes as assessed by the short-form health survey (SF-36) [ Time Frame: Baseline, 12, 26, 39, and 52 weeks ]

Estimated Enrollment: 34
Actual Study Start Date: January 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with dcSSc
Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
Drug: Oral Ifetroban
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Other Name: Ifetroban
Drug: Oral Placebo
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Other Name: Ifetroban
Experimental: Patients with SSc-PAH
Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
Drug: Oral Ifetroban
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Other Name: Ifetroban
Drug: Oral Placebo
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Other Name: Ifetroban

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 5 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 65 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 rituximab or pirfenidone;
  6. Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent;
  7. Significant lung disease, defined as FVC < 50% predicted or DLCO <40% predicted;
  8. Significant kidney disease, defined as Glomerular Filtration Rate (GFR) < 60 ml/min;
  9. Have moderate or severe hepatic impairment;
  10. Contraindication to MRI (e.g., implanted magnetic material, claustrophobia);
  11. Known hypersensitivity to gadolinium;
  12. Any cause of pulmonary hypertension other than World Health Organization (WHO) Group I associated with SSc;
  13. Use of aspirin > 81 mg per day in the last two weeks;
  14. Use of warfarin, heparin or other anticoagulants in the last 30 days;
  15. Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias;
  16. Have a history of allergy or hypersensitivity to ifetroban;
  17. Have taken investigational drugs within 30 days before study treatment administration;
  18. 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;
  19. Be otherwise unsuitable for the study, in the opinion of the investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682511


Contacts
Contact: Byron Kaelin, RN, BSHS 615-255-0068 ext 250 bkaelin@cumberlandpharma.com
Contact: Jerry Fox, DVM 615-255-0068 ext 226 jfox@cumberlandpharma.com

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095-1670
Contact: Nashla Barroso    310-825-9682      
Principal Investigator: Suzanne Kafaja, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Gwen Leatherman, RN, MS, CCRP    410-550-8582      
Principal Investigator: Laura Hummer, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kaitlin Schalago    617-724-2792      
Contact: Ana Fernandez    617-724-2792      
Principal Investigator: Flavia Castelino, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Alexandra Morquette    212-774-7194      
Principal Investigator: Jessica Gordon, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Contact: Kelley Kajdasz    843-792-5290      
Principal Investigator: Richard Silver, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Rezzan Hekmat, MHS    615-875-8937      
Principal Investigator: Evan Brittain, MD         
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
Principal Investigator: Evan Brittain, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02682511     History of Changes
Other Study ID Numbers: CPI-IFE-004
First Submitted: February 8, 2016
First Posted: February 15, 2016
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cumberland Pharmaceuticals:
Ifetroban
Scleroderma
Systemic Sclerosis

Additional relevant MeSH terms:
Hypertension
Sclerosis
Familial Primary Pulmonary Hypertension
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Autoimmune Diseases
Skin Diseases
Connective Tissue Diseases
Pathologic Processes
Scleroderma, Limited
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Immune System Diseases
Ifetroban
Platelet Aggregation Inhibitors