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

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ClinicalTrials.gov Identifier: NCT02682511
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 8, 2016
First Posted Date  ICMJE February 15, 2016
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 10, 2016)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Scleroderma, Diffuse
  • Scleroderma, Systemic
  • Scleroderma, Limited
  • Sclerosis, Progressive Systemic
  • Skin Diseases
  • Connective Tissue Diseases
  • Pathologic Processes
  • Autoimmune Diseases
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Patients with dcSSc
    Patients with dcSSc will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
    Interventions:
    • Drug: Oral Ifetroban
    • Drug: Oral Placebo
  • Experimental: Patients with SSc-PAH
    Patients with SSc-PAH will be randomized to receive either oral ifetroban or oral placebo daily for 365 days
    Interventions:
    • Drug: Oral Ifetroban
    • Drug: Oral Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2016)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02682511
Other Study ID Numbers  ICMJE CPI-IFE-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cumberland Pharmaceuticals
Study Sponsor  ICMJE Cumberland Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evan Brittain, MD Vanderbilt University Medical Center
PRS Account Cumberland Pharmaceuticals
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP