The AURORA clinical research study is for people who have Idiopathic Pulmonary Fibrosis (IPF). The study will test a new investigational medication to learn if it can potentially prevent further lung damage.
Study participants may be able to join the study if they meet the following criteria:
.png)
40 years of age or older
Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) according to the American Thoracic Society (ATS)
Note: Participants who are on stable antifibrotic (medication that helps slow down further lung damage) therapy may be eligible.
Other study requirements will apply.
Participation in the AURORA study lasts about 11 months. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The investigational study drug, CAL101, is an intravenously administered medication designed to block the activity of a protein called S100A4, which is linked to scarring in the lungs.
You will be assigned at random to a study treatment (CAL101 or placebo*). There is a 60% chance that you will receive the active study drug.
For every 5 participants in the study, 3 will receive CAL101, and 2 will receive placebo .
*A placebo is a substance (such as sugar pills or saline solution) that looks like the study medication but does not have any active ingredients.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), and it can only be used in clinical research studies like AURORA.
.png)
Pulmonary Fibrosis is a disease that causes scarring in the lungs. Idiopathic Pulmonary Fibrosis (IPF) is the most common type of Pulmonary Fibrosis. The word “idiopathic” means it has no known cause. The tiny air sacs in the lungs get damaged, which leads to scarring. Over time, the scarring makes it harder for their lungs to work well, and people can find it hard to breathe because their lungs cannot take in as much air. The symptoms of IPF tend to develop gradually and get slowly worse over time.1
Symptoms can include:
One protein that scientists study in IPF is called S100A4. This protein is often found in cells that play a role in scarring. In IPF, S100A4 may be part of why the lungs keep getting damaged.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you.
Contact the study clinic to learn more.