BEACON-IPF for the treatment of idiopathic pulmonary fibrosis
- Study HIC#:2000035682
- Last Updated:04/30/2024
The study is for people who: Are 40 years of age or older at screening. Have a current diagnosis of IPF (within 7 years prior to screening). The study will examine whether bexotegrast can slow down or halt the progression of IPF by reducing scar formation (fibrosis) in participants over the study period. The study will also assess what effects bexotegrast has on participants’ lung function. Your participation in the study will last for approximately one year.
Contact Us
For more information about this study, including how to volunteer, contact:
Danielle Antin-Ozerkis, MD
- Phone Number: 1-203-785-4196
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
The study is for people who: Are 40 years of age or older at screening. Have a current diagnosis of IPF (within 7 years prior to screening). The study will examine whether bexotegrast can slow down or halt the progression of IPF by reducing scar formation (fibrosis) in participants over the study period. The study will also assess what effects bexotegrast has on participants’ lung function. Your participation in the study will last for approximately one year.
Eligibility Criteria
Inclusion Criteria:
Each participant must meet the following criteria to be enrolled in this study:
1. ≥ 40 years of age prior to screening
2. IPF diagnosis ≤ 7 years 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%
4. DLCOpp (hemoglobin-adjusted) ≥ 30% and < 90%
5. Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
6. If not currently receiving treatment for IPF (either treatment naïve or discontinued prior treatment), participant must not have taken background therapy for at least 8 weeks prior to screening
7. Estimated glomerular filtration rate ≥ 30 mL/min, according to the Cockcroft-Gault equation
8. Female participant of nonchildbearing potential must be surgically sterile or postmenopausal (refer to Section 5.7.4)
9. Female participant of childbearing potential must use a contraceptive method with a failure rate of < 1% per year or remain abstinent (refrain from heterosexual intercourse) during the Treatment Period and for 4 weeks after the last dose of study drug(s) (refer to Section 5.7.4)
10. Male participant with female partner of childbearing potential must agree to use contraceptive measures (refer to Section 5.7.4) or remain abstinent (refrain from heterosexual intercourse) 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
