Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT05571059 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CPI-IFE-008
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

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.

  Baseline through 12 months

Secondary Outcomes (10)

• 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

  Baseline through 12 months

• Time to first acute IPF exacerbation or death

  Baseline through 12 months

• Proportion of patients with acute exacerbations of lung fibrosis

  Baseline through 12 months

• Time to hospitalization for respiratory cause or death

  Baseline through 12 months

• Change from baseline in quality of life (SOBQ)

  Baseline through 12 months

Study Arms (2)

Ifetroban Sodium

EXPERIMENTAL

Drug: Ifetroban Oral capsule, 250 mg, once daily for 12 months

Drug: Ifetroban Sodium

Placebo

PLACEBO COMPARATOR

Drug: Placebo Matching placebo, oral capsule, once daily for 12 months

Drug: Placebo

Interventions

Ifetroban Sodium DRUG

Once daily oral ifetroban

Also known as: ifetroban

Ifetroban Sodium

Placebo DRUG

Matching oral placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 40 years or older
• IPF Diagnosis:
• 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 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).
• 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.
• FVC ≥ 40% of predicted normal according to Global Lung Initiative (GLI)
• Diffusion Capacity of Carbon Monoxide (DLCO) \[corrected for hemoglobin\] ≥ 25% to \<80% of predicted normal

You may not qualify if:

• 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.
• Acute IPF exacerbation within 6 weeks prior to screening and/or during the screening period (investigator-determined).
• ILD associated with other known causes
• Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Day 0 and/or during the screening period.
• 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).
• AST or ALT \> 1.5 x ULN, Bilirubin \> 1.5 x ULN, Creatinine clearance \< 30 mL/min calculated by Cockcroft-Gault formula.
• Underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
• Cardiovascular diseases, any of the following:
• Severe hypertension, uncontrolled despite treatment (≥160/100 mmHg)
• Myocardial infarction within 6 months of Day 0
• Unstable cardiac angina
• Bleeding risk, any of the following:

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (19)

Biosolutions Clinical Research

La Mesa, California, 91942, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Miami VA Health System

Miami, Florida, 33125, United States

RECRUITING

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Indiana University Health

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Kansas

Kansas City, Kansas, 66160, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48073, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

UNC Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Bend Memorial Hospital

Bend, Oregon, 97701, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Avera Research Institute

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Pulmonary & Sleep Specialists

Dickson, Tennessee, 37055, United States

RECRUITING

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, 75020, United States

RECRUITING

UW Health University Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Related Publications (1)

• Suzuki T, Kropski JA, Chen J, Carrier EJ, Chen X, Sherrill TP, Winters NI, Camarata JE, Polosukhin VV, Han W, Rathinasabapathy A, Gutor S, Gulleman P, Sabusap C, Banovich NE, Tanjore H, Freeman ML, Tada Y, Young LR, Gokey JJ, Blackwell TS, West JD. Thromboxane-Prostanoid Receptor Signaling Drives Persistent Fibroblast Activation in Pulmonary Fibrosis. Am J Respir Crit Care Med. 2022 Sep 1;206(5):596-607. doi: 10.1164/rccm.202106-1503OC.

  PMID: 35728047 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

ifetroban

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Todd Rice, MD, MSc

  Cumberland Pharmaceuticals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ines Macias-Perez, PhD

CONTACT

6159795778; imaciasperez@cumberlandpharma.com

Ingrid Anderson, PhD, CCRP

CONTACT

615-627-4121; ianderson@cumberlandpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each individual bottle is labelled with a unique numeric code that identifies the contents to the unblinded sponsor representative.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 7, 2022
• Study Start: January 31, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)