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Prostaglandin Receptor Antagonist

Ifetroban for Pulmonary Fibrosis

Phase 2
Recruiting
Led By Todd Rice, MD, MSc
Research Sponsored by Cumberland Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Having UIP or probable UIP based on chest HRCT obtained within 2 months of Day 0, or historical lung biopsy consistent with UIP
Meeting specific requirements for receiving antifibrotic agents pirfenidone or nintedanib
Must not have
History of active or suspected malignancy within 5 years, evidence of active infection
Recent acute IPF exacerbation or ILD associated with other known causes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 12 months

Summary

This trial will test if a drug called Ifetroban can help treat lung fibrosis caused by various factors like bleomycin, genetics, or radiation. The study will look at how safe and effective

Who is the study for?
This trial is for men and women over 40 with Idiopathic Pulmonary Fibrosis (IPF) who meet specific diagnostic criteria. They should have a certain lung function level, may be on stable doses of antifibrotic agents or treatment for pulmonary hypertension, but not have significant emphysema or recent major health events like surgery or heart disease.
What is being tested?
The trial tests the safety and effectiveness of oral Ifetroban in treating IPF compared to a placebo. Participants will either receive Ifetroban Sodium or an inactive substance without knowing which one they are taking to measure true effects.
What are the potential side effects?
While the side effects of Ifetroban in this context aren't detailed here, common risks might include digestive issues, potential liver or kidney function changes, bleeding risks due to its effect on blood cells and vessels, as well as possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My recent chest scan or past lung biopsy shows a pattern of lung scarring.
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I am eligible for treatment with pirfenidone or nintedanib.
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had cancer or an active infection in the last 5 years.
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I recently had a sudden worsening of my lung condition.
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I have a history of heart disease, bleeding risks, or brain bleeds.
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I have not recently coughed up blood, had blood in my urine, or active bleeding in my stomach or intestines.
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My lung function test shows significant airway obstruction.
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I am currently taking pirfenidone and nintedanib.
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I have not recently attempted suicide or been infected with COVID-19.
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I have a history of blood clots or abnormal blood clotting tests.
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I have liver or kidney problems or a chronic liver condition.
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I have severe PAH or emphysema shown on a CT scan.
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I understand and can follow the trial's procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Forced Vital Capacity (FVC) in mL
Secondary study objectives
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ifetroban SodiumExperimental Treatment1 Intervention
Drug: Ifetroban Oral capsule, 250 mg, once daily for 12 months
Group II: PlaceboPlacebo Group1 Intervention
Drug: Placebo Matching placebo, oral capsule, once daily for 12 months

Find a Location

Who is running the clinical trial?

Cumberland PharmaceuticalsLead Sponsor
62 Previous Clinical Trials
9,313 Total Patients Enrolled
Todd Rice, MD, MScPrincipal InvestigatorCumberland Pharmaceuticals
~72 spots leftby Jan 2026
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