The main goal of the study is to find out whether bexotegrast slows down or halts disease progression over a 52-week treatment period by reducing scar formation (fibrosis) of the lungs.
BEACON-IPF is now recruiting adults aged 40 years and older with Idiopathic Pulmonary Fibrosis (IPF). People are eligible regardless of whether they are or are not taking the medications nintedanib or pirfenidone for their IPF. Participants can continue to take existing medications throughout the study.
Participants will be randomly placed into 3 groups to receive either one of two doses of bexotegrast or receive a placebo. Participants will take the different doses of bexotegrast and placebo by mouth, as tablets, once a day.
The total duration of participation is approximately 1 year. Participants in the study will go through a screening period, a treatment period and a follow-up period after the completion of their last dose of bexotegrast or placebo.
Participants will be asked to attend 8 study site visits during the treatment period. During each study site visit, the doctor will assess the participant’s overall health and conduct tests as part of routine care and research, such as lung function tests, blood and urine tests, physical exams, and health questionnaires.
Resources to support study participants may include but are not limited to reimbursement for travel expenses, food or food vouchers.
BEACON-IPF is taking place at locations across the US and globally. If you don’t live close to a study site, but you want to take part in the trial, then some travel-related costs may be reimbursed. Further details will be provided.
The trial is taking place at the locations shown on the map below.
A clinical research study is a medical research study involving human participants. It tests the use of an investigational medical procedure, medical device, drug, or potential treatment, and is led by researchers and study doctors. Clinical studies provide researchers with valuable information such as a better understanding of a condition, which opens doors for new or improved treatments to be made available in the future. A study drug must pass three phases of clinical testing before it is considered for approval by a country’s regulatory authority and made available to the public. BEACON-IPF is a Phase 2b study.
Phase 1: Study drug is given to a small group of healthy volunteers or patients. Researchers evaluate the safety, side effects, best dose, and timing of a new treatment.
Phase 2: Study drug is given to a group of participants with the target disease that the drug is intended to treat. Researchers evaluate the appropriate dosage and learn more about the safety and tolerability profile of the study drug as well as how well it works.
Phase 3: Study drug is given to a larger group of participants with the targeted disease over a longer duration to evaluate the study drug’s safety and effectiveness. In this phase comparisons are sometimes made between the study drug and approved medications for the intended indication.
Phase 4: This phase is conducted after a study drug has been approved for public use. The approved drug may be compared with other drugs on the market or researchers may monitor the drug’s long-term effectiveness and impact on patients’ quality of life.
Participants should be aware of study details prior to participating, including what to expect at study visits, specifics on the administration of the study drug, the potential risks and benefits, and other important information. Prior to participating, potential study participants will meet with the study doctor to review additional details and ask remaining questions. Written information on the study will be provided for their review as well as to share with their family and friends.
Upon agreeing to take part in the study, participants will be given the informed consent form to sign. By signing this form, participants voluntarily consent to taking part in the study. Even after they provide informed consent to participate, they are free to leave the study at any time and for any reason.
All medications, whether approved or undergoing clinical evaluation, may potentially cause side effects – some of which are known, while others may not have been previously observed. In addition, study procedures may also involve certain risks. Study participants will be informed about all of the study drug’s known potential side effects and the study’s procedures prior to their participation. Should additional risks be discovered during the course of the study, participants will be immediately informed.
Participants will take part in the BEACON-IPF study for approximately 1 year. Participation in BEACON-IPF is voluntary with participants free to leave the study at any time.
BEACON-IPF study participants will receive procedures including lab work, tests, study visits, and study drugs at no charge. Reimbursement to cover out-of-pocket expenses such as meals, transportation and parking associated with site visits is available.
BEACON-IPF study participants will be randomly assigned to receive one of two doses of bexotegrast or placebo. The placebo looks identical to bexotegrast but contains no active drug. In clinical trials, experimental drugs are often compared with a placebo to evaluate the treatment’s safety and effectiveness.
In BEACON-IPF, one of every three participants will take placebo. Neither the participant nor the study doctor or study staff will know whether the study participant is receiving bexotegrast or placebo. In the case of an emergency, it is possible for the study doctor to obtain this information.
Participation in the BEACON-IPF study is voluntary. Participants are free to leave the study at any time, with their future care not impacted in any way. The participant’s doctor will continue to look after them and advise them about alternative treatment options.