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New treatment option for Idiopathic Pulmonary Fibrosis
Official title A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
ClinicalTrials.gov ID: NCT07036523
What this study is testing
What is BI 765423?
BI 765423 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 40 years of age or older at the time of informed consent signature.
- Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals...
- Male or female patients. Male patients with Woman of childbearing potential (WOCBP) sexual partners must use contraception (male condom) to avoid...
- Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy)
- Postmenopausal, defined as no menses for 12 months without an alternative medical cause. In questionable cases of postmenopausal status:
You likely can't join if
- Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and/or during the screening period (investigator-determined).
- Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7) at Visit 1.
- Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
- Significant PH defined by any of the following:
- Previous clinical or echocardiographic evidence of significant right heart failure according to investigator's judgement
- History of right heart catheterisation showing a cardiac index ≤2 L/min/m\^²
See the full eligibility criteria
- 40 years of age or older at the time of informed consent signature.
- Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation...
- Male or female patients. Male patients with Woman of childbearing potential (WOCBP) sexual partners must use contraception (male condom) to avoid exposure via seminal fluid during treatment and for a specific period...
- Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy)
- Postmenopausal, defined as no menses for 12 months without an alternative medical cause. In questionable cases of postmenopausal status:
- Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of follicle stimulating hormone (FSH) \> 40 U/L and estradiol \< 30 ng/L"
- Patients with a documented diagnosis of IPF prior to Visit 1, confirmed by the investigator as per the 2022 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin...
- Patients with a high-resolution computed tomography (HRCT) taken within 12 months of Visit 1 (or during the screening period, if not available) confirming "UIP" or "probable UIP" HRCT pattern consistent with the...
- Patients with an "indeterminate" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a "UIP" or...
- Patients with an "alternative diagnosis" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a...
- Patients with an extent of fibrosis ≥20% as per an HRCT of the chest performed within 12 months prior to Visit 1 or during the screening period (if not available) and confirmed by central review.
- Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI).
- Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1. Further apply.
- Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and/or during the screening period (investigator-determined).
- Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7) at Visit 1.
- Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
- Significant PH defined by any of the following:
- Previous clinical or echocardiographic evidence of significant right heart failure according to investigator's judgement
- History of right heart catheterisation showing a cardiac index ≤2 L/min/m\^²
- PH requiring parenteral therapy with prostanoids
- On nintedanib or pirfenidone treatment for less than 12 weeks prior Visit 1, planning to start nintedanib or pirfenidone within the first 12 weeks of investigational medicinal product (IMP) treatment or on combined...
- Cardiovascular comorbidities including
- Severe hypertension (uncontrolled under treatment≥160/100 mmHg at multiple occasions) within 3 months of Visit 1
- Myocardial infarction, stroke, or transient ischemic attack within 6 months of Visit 1
- Unstable cardiac angina within 6 months of Visit 1
- Life expectancy for any concomitant disease other than IPF \<2.5 years (investigator assessment). Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gainesville, Florida, United States
- Ocala, Florida, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Minneapolis, Minnesota, United States
- Chesterfield, Missouri, United States
- Columbia, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Franklin, Tennessee, United States
- Charlottesville, Virginia, United States
- Chermside, Queensland, Australia
- Clayton, Victoria, Australia
- Nedlands, Western Australia, Australia
- Brussels, Belgium
- Yvoir, Belgium
- Sherwood Park, Alberta, Canada
+ 25 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gainesville, Florida, United States; Ocala, Florida, United States; Iowa City, Iowa, United States; Kansas City, Kansas, United States; Minneapolis, Minnesota, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.