Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
ConditionIdiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorCumberland Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female age 40 years or older
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
UIP or probable UIP based on chest HRCT obtained within 2 months of Day 0, or historical lung biopsy consistent with UIP.
If receiving antifibrotic therapy, patients must be receiving a stable dose for ≥ 4 months prior to Day 0 and planning to stay on stable background therapy. Allowable antifibrotic therapy includes: pirfenidone, nintedanib, nerandomilast, pirfenidone with nerandomilast, or nintedanib with nerandomilast (combination of pirfenidone and nintedanib not allowed). If not receiving antifibrotic therapy, patients must be naive to each drug (pirfenidone, nintedanib, nerandomilast) 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. Changes in antifibrotic therapy are not allowed on study.
Disqualifiers
Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second to forced vital capacity ratio less than 70% (FEV1/FVC < 0.7))
In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
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.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ifetroban Sodium
DrugOnce daily oral ifetroban
Placebo
DrugMatching oral placebo
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Ifetroban SodiumExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in Forced Vital Capacity (FVC) in mL
To demonstrate a reduction in lung function decline for ifetroban compared to placebo over 52 weeks.
Time frame
Baseline through 12 monthsSecondary outcomes
1
Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death
Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death over 52 weeks
Time frame
Baseline through 12 months2
Time to first acute IPF exacerbation or death
Time to first acute IPF exacerbation or death over 52 weeks
Time frame
Baseline through 12 months3
Proportion of patients with acute exacerbations of lung fibrosis
Proportion of patients with acute exacerbations of lung fibrosis, defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as deemed by the investigator, for the following: * Acute worsening or development of dyspnea (\<1-month duration). * Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern of lung fibrosis. * Respiratory deterioration not fully explained by cardiac failure or fluid overload.
Time frame
Baseline through 12 months4
Time to hospitalization for respiratory cause or death
Time to hospitalization for respiratory cause or death over 52 weeks
Time frame
Baseline through 12 monthsSponsors and contacts
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Source ClinicalTrials.gov