Idiopathic Pulmonary FibrosisPhase 2NCT05571059
Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing Ifetroban Sodium in people with Idiopathic Pulmonary Fibrosis, run by Cumberland Pharmaceuticals at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Ifetroban Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 20 sitesUnited States
- Study dates
- 31 Jan 2024to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
- 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
Who cannot join
- 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
Show all 37Show fewer
- 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:
- Known genetic predisposition to bleeding.
- Patients who require:
- Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, direct oral anticoagulants, heparin, hirudin) ii. High dose antiplatelet therapy (> 325 mg/day of aspirin; > 75 mg/day ticlodipine or clopidogrel; any dose of other 2b3a anti-platelet agents)
- History of hemorrhagic central nervous system (CNS) event within 12 months of Day 0
- Any of the following within 3 months of Day 0:
- Hemoptysis or hematuria
- Active gastro-intestinal (GI) bleeding needing hospitalization/intervention or peptic ulcer disease
- Coagulation parameters: International normalized ratio (INR) >2, prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) by >1.5 x ULN
- Note: Prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. less than or equal to enoxaparin 40 mg subcutaneously (SC) per day or heparin 5000 units SC every eight hours), low-dose FXa inhibitors (rivaroxaban/apixaban: 2.5mg twice daily (max 5mg/day), edoxaban: 15mg/day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid [ASA] up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent doses of other antiplatelet therapy) are not prohibited.
- History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Day 0
- Use of disease-modifying antirheumatic drugs, B-cell depleting therapies or immunosuppressive medications, within 6 months of Day 0.
- Use of systemic corticosteroids equivalent to prednisone >15mg/day within 2 weeks of Day 0.
- Simultaneous use of pirfenidone and nintedanib at screening.
- 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.
- 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.
- Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings.
- 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.
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- 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.
- Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy
- In the opinion of the Investigator, active alcohol or drug abuse.
- Patients not able to understand or follow trial procedures including completion of self- administered questionnaires without help.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 18 recruiting
- Recruiting
Bend Memorial Hospital
Bend, Oregon, 97701
Natanya Hernandez, 541-706-2302, nahernandez@summithealth.com
Jeremy Feldman, MD
- Recruiting
UNC Chapel Hill
Chapel Hill, North Carolina, 27514
Jackson Pettee, 919-843-4450, jackson.pettee@med.unc.edu
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60611
Aaron Gundersheimer, 312-503-7475, aaron.gundersheimer@northwestern.edu
Krishnan Warrior, MD
- Recruiting
Baylor University Medical Center
Dallas, Texas, 75246
Jordan Brown, (214) 820-1737, jordan.brown1@BSWHealth.org
Susan Mathai, MD
- Recruiting
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020
Muhammad (Mo) Butt, 469-714-9864, crc@premierpsm.com
Sanober Kable, MD
- Active, not recruiting
Pulmonary & Sleep Specialists
Dickson, Tennessee, 37055
- Recruiting
UConn Health
Farmington, Connecticut, 06030
Nicole Glidden, (860) 679-4647, nglidden@uchc.edu
- Recruiting
Indiana University Health
Indianapolis, Indiana, 46202
Kim McPeak, 317-962-1138, kmcpeak@iuhealth.org
Damien Patel, MD
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Jhozia Duncan, 904-953-4991, duncan.jhozia@mayo.edu
Augustine Lee, MD
- Recruiting
University of Kansas
Kansas City, Kansas, 66160
Amber Okunrinboye, 913-945-9253, aokunrinboye@kumc.edu
Mark Hamblin, MD
- Active, not recruiting
Biosolutions Clinical Research
La Mesa, California, 91942
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Joan Hamlyn, 502-852-0560, joan.hamlyn@louisville.edu
Mohamed Saad, MD
- Recruiting
UW Health University Hospital
Madison, Wisconsin, 53792
Yuliya Henes, 608-262-1789, yhenes@clinicaltrials.wisc.edu
- Recruiting
Miami VA Health System
Miami, Florida, 33125
Carol Ramos, 305-310-2614, carol.ramos@va.gov
Robert Jackson, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Olia Ali, 347-393-6217, olia.ali@mssm.edu
Maria Padilla, MD
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Debasree Sana Boral, (215) 707-7249, debasree.sanaboral@tuhs.temple.edu
Gerard Criner, MD
- Recruiting
University of Rochester
Rochester, New York, 14642
Karen McCarthy, 585-276-7294, karen_mccarthy@urmc.rochester.edu
David Nagel, MD, PhD
- Recruiting
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48073
Coleen Tessmar, 248-551-0312, coleen.tessmar@beaumont.org
Enrique Calvo-Ayala, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Sheyla Yamato, 415-353-2296, sheyla.yamato@ucsf.edu
Jeffrey Golden, MD
- Recruiting
Avera Research Institute
Sioux Falls, South Dakota, 57108
Nicholas Sorensen, 605-504-3151, nicholas.sorensen@avera.org
Fady Jamous, MD
About this study
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)
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.
Read the detailed description
This is a multicenter, prospective, randomized, placebo-controlled, phase II study to determine the safety and efficacy of oral ifetroban compared to placebo in subjects with IPF. Patients who meet the inclusion criteria and none of the exclusion criteria will receive oral ifetroban or placebo once daily for 12 months. Subjects will be randomly assigned to one of two oral treatment groups: ifetroban or placebo and block randomized by background therapy. All subjects who receive treatment will be assessed for safety. All subjects with at least one efficacy assessment post-baseline will be evaluated for efficacy. Blood and urine will be collected for standard and novel PPF biomarkers.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Ifetroban Sodium, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifetroban SodiumDrug
Also called ifetroban
Once daily oral ifetroban
PlaceboDrug
Matching oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Ifetroban Sodium | Experimental | Drug: Ifetroban Oral capsule, 250 mg, once daily for 12 months Receives: Drug: Ifetroban Sodium |
| Placebo | Placebo comparator | Drug: Placebo Matching placebo, oral capsule, once daily for 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Baseline through 12 months
Time to first acute IPF exacerbation or death
Time to first acute IPF exacerbation or death over 52 weeks
Measured: Baseline through 12 months
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.
Measured: Baseline through 12 months
Time to hospitalization for respiratory cause or death
Time to hospitalization for respiratory cause or death over 52 weeks
Measured: Baseline through 12 months
Change from baseline in quality of life (SOBQ)
The University of California, San Diego (UCSD) Medical Center Shortness of Breath Questionnaire (SOBQ) assesses the impact of a subject's lung disease on their quality of life. The assessment scale asks the patient to rate their breathlessness while performing a specific task using a numeric scale from 0 - 5, with 0 being "none at all" and 5 being "maximal or unable to do because of breathlessness". Lower scores = low impact; higher scores = higher impact. Scores from the survey will be evaluated at each timepoint and compared to baseline to assess for changes.
Measured: Baseline through 12 months
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score
The Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire assesses the impact of a subject's lung disease on their quality of life in three areas: dyspnea, cough and fatigue. The assessment scale asks the patient several questions in each domain. In the dyspnea domain, the patient is to rate each question based on how they have been feeling over the last 7 days using a numeric scale from 0 - 4, with 0 being "not at all" or "extremely poor" and 4 being "extremely" or "excellent". Lower scores = low impact; higher scores = higher impact. Scores from the survey will be evaluated at each timepoint and compared to baseline to assess for changes.
Measured: Baseline through 12 months
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score
The Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire assesses the impact of a subject's lung disease on their quality of life in three areas: dyspnea, cough and fatigue. The assessment scale asks the patient several questions in each domain. In the Cough domain, the patient is to rate each question based on how they have been feeling over the last 7 days using a numeric scale from 0 - 4, with 0 being "never" or "none at all" or "none" or "Not at all" or very little time" and 4 being "extremely" or "all of the time" or "A lot" or "extremely long time". Lower scores = low impact; higher scores = higher impact. Scores from the survey will be evaluated at each timepoint and compared to baseline to assess for changes.
Measured: Baseline through 12 months
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score
The Living with Pulmonary Fibrosis (L-PF) Impacts Questionnaire assesses the impact of a subject's lung disease on their quality of life in three areas: dyspnea, cough and fatigue. The assessment scale asks the patient several questions in each domain. In the Fatigue domain, the patient is to rate each question based on how they have been feeling over the last 7 days using a numeric scale from 0 - 4, with 0 being "Made my quality of life extremely poor" or "Extremely poor" and 4 being "No negative effect" or "Excellent". Lower scores = high impact; higher scores = low impact. Scores from the survey will be evaluated at each timepoint and compared to baseline to assess for changes.
Measured: Baseline through 12 months
Time to death
Time to death over 52 weeks
Measured: Baseline through 12 months
Incidence of Treatment Emergent Adverse Events (safety & tolerability)
Percentage of subjects with one or more treatment emergent adverse event
Measured: Baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start31 Jan 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Rice, MD, MSc, Principal investigator, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571059
- Sponsor's protocol ID
- CPI-IFE-008
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35728047
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05571059
- Acronym / sponsor ID
- CPI-IFE-008
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, prospective, randomized, placebo-controlled, phase II study to determine the safety and efficacy of oral ifetroban compared to placebo in subjects with IPF. Patients who meet the inclusion criteria and none of the exclusion criteria will receive oral ifetroban or placebo once daily for 12 months. Subjects will be randomly assigned to one of two oral treatment groups: ifetroban or placebo and block randomized by background therapy. All subjects who receive treatment will be assessed for safety. All subjects with at least one efficacy assessment post-baseline will be evaluated for efficacy. Blood and urine will be collected for standard and novel PPF biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Ifetroban Sodium | Experimental | Drug: Ifetroban SodiumDrug: Ifetroban Oral capsule, 250 mg, once daily for 12 months |
| Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo Matching placebo, oral capsule, once daily for 12 months |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female age 40 years or older
- IPF Diagnosis:
- 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.
- 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)
Key exclusion criteria (37 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ifetroban SodiumAlso: ifetrobanOnce daily oral ifetroban | Drug | Ifetroban Sodium |
| PlaceboMatching oral placebo | Drug | Placebo |
Primary outcome
Change from baseline in Forced Vital Capacity (FVC) in mL
Time frame: Baseline through 12 months
To demonstrate a reduction in lung function decline for ifetroban compared to placebo over 52 weeks.
10 secondary outcomes
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 frame: Baseline through 12 months
Time to first acute IPF exacerbation or death
Time frame: Baseline through 12 months
Proportion of patients with acute exacerbations of lung fibrosis
Time frame: Baseline through 12 months
Time to hospitalization for respiratory cause or death
Time frame: Baseline through 12 months
Change from baseline in quality of life (SOBQ)
Time frame: Baseline through 12 months
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score
Time frame: Baseline through 12 months
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score
Time frame: Baseline through 12 months
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score
Time frame: Baseline through 12 months
Time to death
Time frame: Baseline through 12 months
Incidence of Treatment Emergent Adverse Events (safety & tolerability)
Time frame: Baseline through 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 35728047Suzuki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Todd Rice, MD, MSc principal investigator
Cumberland Pharmaceuticals
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ifetroban Sodium in people with Idiopathic Pulmonary Fibrosis, run by Cumberland Pharmaceuticals at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ines Macias-Perez, PhD (6159795778, imaciasperez@cumberlandpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Forced Vital Capacity (FVC) in mL (time frame: Baseline through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.