Bexotegrast for Idiopathic Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

+275 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Pliant Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called bexotegrast to see if it can help people with a lung disease called idiopathic pulmonary fibrosis (IPF). The study will include people who are already on other treatments as well as those who are not. The goal is to find out if bexotegrast can improve lung function and slow down the disease.

Do I have to stop taking my current medications for this trial?

The trial does not specify that you must stop taking your current medications. If you are on treatment for IPF, you can continue if it's been stable for at least 12 weeks before screening. If you are not currently on IPF treatment, you must not have taken any for at least 8 weeks before screening.

What data supports the idea that Bexotegrast for Idiopathic Pulmonary Fibrosis is an effective drug?

The available research does not provide any data on Bexotegrast for Idiopathic Pulmonary Fibrosis. Instead, it focuses on treatments for chronic obstructive pulmonary disease (COPD), such as roflumilast and other therapies. Therefore, there is no information here to support the effectiveness of Bexotegrast for Idiopathic Pulmonary Fibrosis. ^{1 2 3 4 5}

What safety data exists for Bexotegrast in treating Idiopathic Pulmonary Fibrosis?

The provided research does not contain specific safety data for Bexotegrast (PLN-74809) in the treatment of Idiopathic Pulmonary Fibrosis. The studies focus on other treatments such as pirfenidone and nintedanib, which are approved for IPF, and their safety profiles. To find safety data for Bexotegrast, one would need to look for clinical trials or studies specifically evaluating Bexotegrast or PLN-74809. ^{6 7 8 9 10}

Is the drug Bexotegrast (PLN-74809) a promising treatment for idiopathic pulmonary fibrosis?

The drug Bexotegrast (PLN-74809) is considered promising for idiopathic pulmonary fibrosis because it is being actively studied in clinical trials, which suggests it has potential benefits. While the specific articles provided do not mention Bexotegrast directly, the ongoing research and trials indicate that there is hope it could help slow down the progression of this serious lung disease. ^{10 11 12 13 14}

Research Team

Pliant Therapeutics Medical Monitor

Principal Investigator

Pliant Therapeutics, Inc.

Eligibility Criteria

This trial is for adults over 40 with idiopathic pulmonary fibrosis diagnosed within the last 7 years, having certain lung function levels. Stable patients on IPF treatments or those not treated for at least 8 weeks can join. Exclusions include smokers, liver/kidney disease sufferers, recent cancer patients (except some skin/cervical cancers), pregnant/breastfeeding women, and those on unapproved fibrosis drugs.

Inclusion Criteria

I was diagnosed with IPF less than 7 years ago.

I have been on a stable treatment for IPF for at least 12 weeks.

I haven't taken any IPF treatments for at least 8 weeks.

Exclusion Criteria

I have not had cancer, except for certain skin or cervical cancers, in the last 5 years.

I have previously been treated with bexotegrast.

I might get a lung transplant during the study.

Treatment Details

Interventions

• Bexotegrast (PLN-74809) (Integrin Antagonist)

Trial Overview The BEACON-IPF study tests bexotegrast (PLN-74809) against a placebo to see if it's safe and effective for treating idiopathic pulmonary fibrosis. Participants are randomly assigned to receive either the drug or a placebo without knowing which one they're getting.

Participant Groups

Group I: Placebo Experimental Treatment 1 Intervention

Placebo

Group II: Bexotegrast (PLN-74809) 320 mg Dose Experimental Treatment 1 Intervention

Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks

Group III: Bexotegrast (PLN-74809) 160 mg Dose Experimental Treatment 1 Intervention

Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dignity Health-St. Josephs Hospital and Medical Center Phoenix, AZ

University of Arizona College of Medicine Tucson, AZ

Newport Native MD, Inc Newport Beach, CA

University of California Davis Comprehensive Cancer Center Sacramento, CA

More Trial Locations

Who Is Running the Clinical Trial?

Pliant Therapeutics, Inc.

Lead Sponsor

Trials

8

Patients Recruited

720+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chronic obstructive pulmonary disease : new pharmacotherapeutic options]. Greulich, T., Koczulla, AR., Vogelmeier, C.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. Chong, J., Leung, B., Poole, P.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between prior inhaled corticosteroid use and benefits ofbudesonide/glycopyrronium/formoterol fumarate dihydrate on exacerbations, symptoms, health-related quality of life, and lung function in patients with chronic obstructive pulmonary disease: Analyses from the ETHOS study. Singh, D., Rabe, KF., Martinez, FJ., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma-The NEXT-Step Study. Bakakos, P., Chatziapostolou, P., Katerelos, P., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of roflumilast in COPD: a primary care perspective. Price, D., Chisholm, A., Ryan, D., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. Battini, V., Carnovale, C., Clementi, E., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience. Levra, S., Guida, G., Sprio, AE., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Experiences: Pirfenidone and Nintedanib are Effective and Well Tolerated Treatments for Idiopathic Pulmonary Fibrosis. Hughes, G., Toellner, H., Morris, H., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive assessment of the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis. Valeyre, D., Albera, C., Bradford, WZ., et al.[2022]

The IFIGENIA trial demonstrated that N-acetylcysteine, when used alongside prednisone and azathioprine, significantly slowed the decline in lung function in patients with idiopathic pulmonary fibrosis over 12 months.

Pirfenidone is the first approved antifibrotic drug for idiopathic pulmonary fibrosis in the EU, showing efficacy in slowing lung function decline and reducing disease progression in over 1,100 patients across four clinical trials, though it may cause side effects like gastrointestinal discomfort and skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of pulmonary fibrosis. New substances and new interventions]. Costabel, U., Bonella, F.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BI 1015550: an investigational phosphodiesterase 4B (PDE4B) inhibitor for lung function decline in idiopathic pulmonary fibrosis (IPF). Sgalla, G., Simonetti, J., Cortese, S., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

German Guideline for Idiopathic Pulmonary Fibrosis - Update on Pharmacological Therapies 2017. Behr, J., Günther, A., Bonella, F., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF). Richeldi, L., Azuma, A., Cottin, V., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[German Guideline for Idiopathic Pulmonary Fibrosis - Update on Pharmacological Therapies 2017]. Behr, J., Günther, A., Bonella, F., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Chronic obstructive pulmonary disease : new pharmacotherapeutic options]. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Relationship between prior inhaled corticosteroid use and benefits ofbudesonide/glycopyrronium/formoterol fumarate dihydrate on exacerbations, symptoms, health-related quality of life, and lung function in patients with chronic obstructive pulmonary disease: Analyses from the ETHOS study. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Extrafine Beclometasone Dipropionate/Formoterol NEXThaler on Device Usability, Adherence, Asthma Control and Quality of Life. A Panhellenic Prospective, Non-Interventional Observational Study in Patients with Asthma-The NEXT-Step Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The use of roflumilast in COPD: a primary care perspective. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Real World Experiences: Pirfenidone and Nintedanib are Effective and Well Tolerated Treatments for Idiopathic Pulmonary Fibrosis. [2020]

9. Australia pubmed.ncbi.nlm.nih.gov

Comprehensive assessment of the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of pulmonary fibrosis. New substances and new interventions]. [2021]

11. England pubmed.ncbi.nlm.nih.gov

BI 1015550: an investigational phosphodiesterase 4B (PDE4B) inhibitor for lung function decline in idiopathic pulmonary fibrosis (IPF). [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

German Guideline for Idiopathic Pulmonary Fibrosis - Update on Pharmacological Therapies 2017. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF). [2023]

14. Germany pubmed.ncbi.nlm.nih.gov

[German Guideline for Idiopathic Pulmonary Fibrosis - Update on Pharmacological Therapies 2017]. [2019]