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

December 13, 2023 updated by: Cumberland Pharmaceuticals

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • The Universtity of Arizona Arthrtis Center
        • Contact:
        • Principal Investigator:
          • Jawad Bilal, MD
    • California
      • Los Angeles, California, United States, 90095-1670
        • Recruiting
        • UCLA
        • Principal Investigator:
          • Suzanne Kafaja, MD
        • Contact:
          • Nashla Barroso
          • Phone Number: 310-825-9682
    • Florida
      • Hialeah, Florida, United States, 33012
        • Withdrawn
        • New Life Medical Research Center, Inc.
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic - Florida
        • Principal Investigator:
          • Franck Rahaghi, MD
        • Contact:
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins University
        • Contact:
          • Gwen Leatherman, RN, MS, CCRP
          • Phone Number: 410-550-8582
        • Principal Investigator:
          • Laura Hummer, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Ana Frenandez
          • Phone Number: 617-724-2792
        • Principal Investigator:
          • Flavia Castelino, MD
      • Boston, Massachusetts, United States, 02118
        • Withdrawn
        • Boston University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Tammy Wichman, MD
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Principal Investigator:
          • Jessica Gordon, MD
        • Contact:
          • Beemnet Amdemicael
          • Phone Number: 212-774-2123
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Fabian A Mendoza-Ballesteros, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Terminated
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Withdrawn
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75204-651
        • Recruiting
        • Baylor Research Institute
        • Contact:
          • Susan
        • Principal Investigator:
          • Susan Mathai, MD
    • Washington
      • Seattle, Washington, United States, 98101
        • Withdrawn
        • Benaraoya Research Institute at Virginia Mason

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Ifetroban
Drug: Oral Placebo
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Other Names:
  • 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 Names:
  • Ifetroban
Drug: Oral Placebo
Subjects will be treated with oral ifetroban or placebo daily for 365 days
Other Names:
  • Ifetroban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
56 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12, 26, and 52 weeks
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)
Baseline, 12, 26, and 52 weeks
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.
Baseline, 12, 26, 39, and 52 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change from baseline in ventricular function as determined by cardiac MRI
Time Frame: Baseline, 26, and 52 weeks
Baseline, 26, and 52 weeks
Change from baseline in ventricular function as determined by echocardiography
Time Frame: Baseline, 26, and 52 weeks
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
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
Baseline, 12, 26, 39, and 52 weeks
Change from baseline in blood biomarkers
Time Frame: Baseline, 26, and 52 weeks
Baseline, 26, and 52 weeks
Change from baseline in skin biomarkers
Time Frame: Baseline, 26, and 52 weeks
Baseline, 26, and 52 weeks
Change from baseline in erythrocyte sedimentation rate
Time Frame: Baseline, 26, and 52 weeks
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
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
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
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
Baseline, 12, 26, 39, and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumberland Pharmaceuticals

Investigators

  • Principal Investigator: Evan Brittain, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimated)

February 15, 2016

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPI-IFE-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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