A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis

JRCT ID: jRCT2051240025

Registered date:07/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: idiopathic pulmonary fibrosis
• Date of first enrollment: 01/08/2024
• Target sample size: 75
• Countries of recruitment: United States,Japan,Canada,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Spain,Japan,United Kingdom,Japan,Australia,Japan,Taiwan,Japan,New Zealand,Japan,South Korea,Japan
• Study type: Interventional
• Intervention(s): Bexotegrast160mg 320mg, or 0mg (placebo) will be taken once daily at approximately 24-hour intervals.

Outcome(s)

• Primary Outcome: To characterize the effect of bexotegrast versus placebo on the change in forced vital capacity (FVC) in participants with idiopathic pulmonary fibrosis (IPF) at Week 52

Secondary Outcome

-To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression
-To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with and without background therapy at baseline with IPF at Week 52
-To characterize the effect of bexotegrast versus placebo after 52 weeks of treatment on overall symptom and functional improvement associated with IPF
-To characterize the effect of bexotegrast versus placebo on change in lung fibrosis by high-resolution computed tomography (HRCT) at Week 52
-To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 40 years of age or above prior to screening
2. IPF diagnosis 7 years or less prior to screening based upon American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Association 2018 guidelines and confirmed with central review (Raghu et al 2018)
3. FVCpp 45% or above
4. DLCOpp (hemoglobin-adjusted) 30% or above and < 90%
5. Current treatment for IPF with background therapy is allowed, if at a stable dose for 12 weeks or more prior to screening
6. If not currently receiving treatment for IPF (either treatment naive or discontinued prior treatment), participant must not have taken background therapy for 8 weeks or more prior to screening
7. Estimated glomerular filtration rate 30 mL/min or above, according to the Cockcroft-Gault equation
8. Female participant of nonchildbearing potential must be surgically sterile or postmenopausal
9. Female participant of childbearing potential must use a highly effective contraceptive method with a failure rate of <1% per year during the Treatment Period and for 4 weeks after the last dose of study drug(s)
10. Male participant with female partner of childbearing potential must agree to use a highly effective contraceptive method with a failure rate of <1% per year during the Treatment Period and for at least 12 weeks after the last dose of study drug(s)
11. Agree to abstain from sperm or egg donation for the duration of the study, through 12 weeks or 4 weeks, respectively, after administration of the last dose of study drug(s)
12. Understand the study procedures and agree to participate in the study by giving written informed consent

Exclude criteria

1. Receiving pharmacologic therapy for pulmonary hypertension
2. Forced expiratory volume in the first second (FEV1)/FVC ratio < 0.7 at screening
3. Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
4. Active viral infection with human immunodeficiency virus, hepatitis A, hepatitis B, or hepatitis C
5. Any other condition that prevents the correct assessment of spirometry performance (for example a broken rib or chest pain of other origin that prevents adequate forced breathing)
6. Known acute IPF exacerbation or suspicion by the Investigator of such, 6 months prior to screening
7. Extent of emphysema that is greater than the extent of fibrotic changes on the most recent HRCT scan (as determined by central reader); an HRCT scan performed within 2 years prior to the screening date may be used
8. Self-reported smoking of any kind (not limited to tobacco) within 12 weeks prior to screening or unwilling to avoid smoking throughout the study
9. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the Screening Period
10. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ
11. Hepatic impairment also known as hepatic failure or liver failure, is characterized as liver dysfunction with a Child-Pugh classification of A, B, or C, or end-stage liver disease
12. Renal impairment, defined as estimated glomerular filtration rate < 30 mL/min, according to the Cockcroft-Gault equation, or end-stage kidney disease requiring dialysis
13. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the 6 months prior to screening

Related Information

• Primary Sponsor: Kanmuri Kazuhiro
• Secondary ID(s): NCT06097260