RECRUITING

Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Ifetroban prevents and treats lung fibrosis due to multiple causes (bleomycin, genetic, radiation). The safety and efficacy of oral ifetroban will be assessed in patients with IPF.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Determine the Safety and Efficacy of Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Quick Facts

Study Start:2024-01-31

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05571059

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.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female age 40 years or older 2. IPF Diagnosis: 1. Satisfying the 2022 American Thoracic Society/European Respiratory Society /Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu 2022) confirmed by the investigator 2. UIP or probable UIP based on chest HRCT obtained within 2 months of Day 0, or historical lung biopsy consistent with UIP. 3. If receiving antifibrotic agents pirfenidone or nintedanib, patients must be receiving a stable dose for ≥ 2 months prior to Day 0 and planning to stay on stable background therapy; if not receiving pirfenidone or nintedanib, patients must be naive to both drugs or not have received either for at least 4 weeks prior to Day 0 and remain off background therapy with no intention to start or re-start (combination of nintedanib and pirfenidone not allowed). 4. If receiving monotherapy for the treatment of pulmonary hypertension (e.g. phosphodiesterase 5 inhibitors, endothelin receptor antagonists or inhaled or oral prostanoid therapy), patients must be receiving a stable dose for ≥ 4 weeks prior to Day 0 and planning to remain on a stable dose throughout the study. 5. FVC ≥ 40% of predicted normal according to Global Lung Initiative (GLI) 6. Diffusion Capacity of Carbon Monoxide (DLCO) \[corrected for hemoglobin\] ≥ 25% to \<80% of predicted normal	1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second to forced vital capacity ratio less than 70% (FEV1/FVC \< 0.7)) 2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities. 3. Known significant PAH, defined as previous clinical or echocardiographic evidence of significant right heart failure, history of right heart catheterization showing a cardiac index \< 2 L/min/m2, or PAH requiring combination of PAH-specific therapies or any PAH parenteral therapy. 4. Emphysema ≥ 50% on HRCT assessed by the investigator, or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent chest HRCT. 5. Acute IPF exacerbation within 6 weeks prior to screening and/or during the screening period (investigator-determined). 6. ILD associated with other known causes 7. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Day 0 and/or during the screening period. 8. Major surgery (major according to the investigator's assessment) performed within six weeks prior to Day 0 or planned during the course of the trial. (Being on a transplant list is allowed). 9. AST or ALT \> 1.5 x ULN, Bilirubin \> 1.5 x ULN, Creatinine clearance \< 30 mL/min calculated by Cockcroft-Gault formula. 10. Underlying chronic liver disease (Child Pugh A, B or C hepatic impairment). 11. Cardiovascular diseases, any of the following: 1. Severe hypertension, uncontrolled despite treatment (≥160/100 mmHg) 2. Myocardial infarction within 6 months of Day 0 3. Unstable cardiac angina 12. Bleeding risk, any of the following: 1. Known genetic predisposition to bleeding. 2. Patients who require: 13. History of hemorrhagic central nervous system (CNS) event within 12 months of Day 0 14. Any of the following within 3 months of Day 0: 1. Hemoptysis or hematuria 2. Active gastro-intestinal (GI) bleeding needing hospitalization/intervention or peptic ulcer disease 15. Coagulation parameters: International normalized ratio (INR) \>2, prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) by \>1.5 x ULN 16. History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Day 0 17. Use of disease-modifying antirheumatic drugs, B-cell depleting therapies or immunosuppressive medications, within 6 months of Day 0. 18. Use of systemic corticosteroids equivalent to prednisone \>15mg/day within 2 weeks of Day 0. 19. Simultaneous use of pirfenidone and nintedanib at screening. 20. Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial. 21. Any documented active or suspected malignancy within 5 years prior to Day 0, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or "under surveillance" prostate cancer. 22. Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings. 23. The patient has a confirmed infection with Severe Acute Respiratory Syndrome- Coronvirus-2 (SARS-CoV-2) within the four weeks prior to Day 0 or during the screening period. 24. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. 25. Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently for 28 days prior to and three months after Investigational Medicinal Product (IMP) administration. 26. In the opinion of the Investigator, active alcohol or drug abuse. 27. Patients not able to understand or follow trial procedures including completion of self- administered questionnaires without help.

Inclusion Criteria

Exclusion Criteria

1. Male or female age 40 years or older
2. IPF Diagnosis:
1. Satisfying the 2022 American Thoracic Society/European Respiratory Society /Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu 2022) confirmed by the investigator
2. UIP or probable UIP based on chest HRCT obtained within 2 months of Day 0, or historical lung biopsy consistent with UIP.
3. If receiving antifibrotic agents pirfenidone or nintedanib, patients must be receiving a stable dose for ≥ 2 months prior to Day 0 and planning to stay on stable background therapy; if not receiving pirfenidone or nintedanib, patients must be naive to both drugs or not have received either for at least 4 weeks prior to Day 0 and remain off background therapy with no intention to start or re-start (combination of nintedanib and pirfenidone not allowed).
4. If receiving monotherapy for the treatment of pulmonary hypertension (e.g. phosphodiesterase 5 inhibitors, endothelin receptor antagonists or inhaled or oral prostanoid therapy), patients must be receiving a stable dose for ≥ 4 weeks prior to Day 0 and planning to remain on a stable dose throughout the study.
5. FVC ≥ 40% of predicted normal according to Global Lung Initiative (GLI)
6. Diffusion Capacity of Carbon Monoxide (DLCO) \[corrected for hemoglobin\] ≥ 25% to \<80% of predicted normal

1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second to forced vital capacity ratio less than 70% (FEV1/FVC \< 0.7))
2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
3. Known significant PAH, defined as previous clinical or echocardiographic evidence of significant right heart failure, history of right heart catheterization showing a cardiac index \< 2 L/min/m2, or PAH requiring combination of PAH-specific therapies or any PAH parenteral therapy.
4. Emphysema ≥ 50% on HRCT assessed by the investigator, or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent chest HRCT.
5. Acute IPF exacerbation within 6 weeks prior to screening and/or during the screening period (investigator-determined).
6. ILD associated with other known causes
7. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Day 0 and/or during the screening period.
8. Major surgery (major according to the investigator's assessment) performed within six weeks prior to Day 0 or planned during the course of the trial. (Being on a transplant list is allowed).
9. AST or ALT \> 1.5 x ULN, Bilirubin \> 1.5 x ULN, Creatinine clearance \< 30 mL/min calculated by Cockcroft-Gault formula.
10. Underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
11. Cardiovascular diseases, any of the following:
1. Severe hypertension, uncontrolled despite treatment (≥160/100 mmHg)
2. Myocardial infarction within 6 months of Day 0
3. Unstable cardiac angina
12. Bleeding risk, any of the following:
1. Known genetic predisposition to bleeding.
2. Patients who require:
13. History of hemorrhagic central nervous system (CNS) event within 12 months of Day 0
14. Any of the following within 3 months of Day 0:
1. Hemoptysis or hematuria
2. Active gastro-intestinal (GI) bleeding needing hospitalization/intervention or peptic ulcer disease
15. Coagulation parameters: International normalized ratio (INR) \>2, prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) by \>1.5 x ULN
16. History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Day 0
17. Use of disease-modifying antirheumatic drugs, B-cell depleting therapies or immunosuppressive medications, within 6 months of Day 0.
18. Use of systemic corticosteroids equivalent to prednisone \>15mg/day within 2 weeks of Day 0.
19. Simultaneous use of pirfenidone and nintedanib at screening.
20. Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
21. Any documented active or suspected malignancy within 5 years prior to Day 0, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or "under surveillance" prostate cancer.
22. Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings.
23. The patient has a confirmed infection with Severe Acute Respiratory Syndrome- Coronvirus-2 (SARS-CoV-2) within the four weeks prior to Day 0 or during the screening period.
24. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
25. Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently for 28 days prior to and three months after Investigational Medicinal Product (IMP) administration.
26. In the opinion of the Investigator, active alcohol or drug abuse.
27. Patients not able to understand or follow trial procedures including completion of self- administered questionnaires without help.

Contacts and Locations

Study Contact

Ines Macias-Perez, PhD

CONTACT

6159795778

imaciasperez@cumberlandpharma.com

Ingrid Anderson, PhD, CCRP

CONTACT

615-627-4121

ianderson@cumberlandpharma.com

Principal Investigator

Todd Rice, MD, MSc

PRINCIPAL_INVESTIGATOR

Cumberland Pharmaceuticals

Study Locations (Sites)

University of California San Francisco

San Francisco, California, 94143

United States

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

United States

Miami VA Health System

Miami, Florida, 33125

United States

Northwestern Medicine

Chicago, Illinois, 60611

United States

Indiana University Health

Indianapolis, Indiana, 46202

United States

University of Kansas

Kansas City, Kansas, 66160

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48073

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

University of Rochester

Rochester, New York, 14642

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

Baylor University Medical Center

Dallas, Texas, 75246

United States

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, 75020

United States

Collaborators and Investigators

Sponsor: Cumberland Pharmaceuticals

Todd Rice, MD, MSc, PRINCIPAL_INVESTIGATOR, Cumberland Pharmaceuticals

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 Registration Dates

Study Start Date2024-01-31

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-01-31

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Idiopathic Pulmonary Fibrosis