BridgeMD
New treatment option for Familial Pulmonary Fibrosis
Official title A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT07201922
What this study is testing
What is Nerandomilast?
Nerandomilast is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for familial pulmonary fibrosis.
Also referred to as BI 1015550, JASCAYD®.
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 people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe.
- Phase 3: a large, late-stage study
- 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
- Individuals ≥40 years of age at the time of first signed informed consent at Visit 1a
- Participants must have at least 1 first-degree relative (biological parent, sibling, or child) with confirmed pulmonary fibrosis (idiopathic...
- High resolution computed tomography (HRCT) scan with evidence of interstitial lung abnormalities involving at least 5% of a single lung zone or...
- Forced vital capacity (FVC) ≥80% of predicted normal at Visit 1b
- Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥70% of predicted normal at Visit 1b Further apply.
You likely can't join if
- Prior known pulmonary fibrosis that, in the opinion of the Investigator, requires treatment with approved therapies
- Prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7 at Visit 1b
- HRCT findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern
- Any medical condition that is known to predispose to the development of pulmonary fibrosis (e.g. known connective tissue disease)
- Prior or current use of nerandomilast, nintedanib, or pirfenidone Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Kissimmee, Florida, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Buenos Aires, Argentina
- CABA, Argentina
- Capital Federal, Argentina
- Camperdown, New South Wales, Australia
- Chermside, Queensland, Australia
- Melbourne, Victoria, Australia
- Brussels, Belgium
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Los Angeles, California, United States; Aurora, Colorado, United States; Kissimmee, Florida, United States; Kansas City, Kansas, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States and 45 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.