BEACON-IPF is a Phase 2b/3 clinical trial to evaluate the investigational drug bexotegrast for the treatment of IPF

The main goal of the trial 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 treatment of their IPF disease. Participants can continue to take their existing IPF medications throughout the trial.

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.

This Phase 2b/3 trial follows an adaptive or operationally seamless protocol. This protocol allows for patient enrollment in the Phase 3 portion immediately following the completion of Phase 2b. The Phase 2b/3 trial is being conducted at global sites outside of the United States.

52 weeks
of treatment
Approximately
200 sites across
20 countries

What to Expect

The total duration of participation is approximately 1 year. Participants in the trial 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 trial site visits during the treatment period. During each trial 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, medical scans, physical exams, and health questionnaires.

Resources to support trial participants may include but are not limited to reimbursement for travel expenses and food or food vouchers.

Screening Period
Up to
5
Weeks
Treatment (52 Weeks)
Day
1
 
Week
4
 
Week
12
 
Week
24
 
Week
36
 
Week
52
 
Follow-up Period
 
2
Weeks

IPF Clinical Trial
Available Locations

BEACON-IPF is taking place at global locations. If you don’t live close to a trial 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.


photo of smiling women

Frequently
Asked
Questions

What is a clinical research trial?

A clinical research trial is a medical research study involving human participants. It tests the use of an investigational medical procedure, medical device, drug, or investigational treatment, and is led by researchers and trial doctors. Clinical trials 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 trial 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/3 trial.

Phase 1: Trial 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: Trial 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 trial drug as well as how well it works.

Phase 3: Trial drug is given to a larger group of participants with the targeted disease over a longer duration to evaluate the trial drug’s safety and effectiveness. In this phase comparisons are sometimes made between the trial drug and approved medications for the intended indication.

Phase 4: This phase is conducted after a trial 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.

What is “informed consent”?

Participants should be aware of trial details prior to participating, including what to expect at trial visits, specifics on the administration of the trial drug, the potential risks and benefits, and other important information. Prior to participating, potential trial participants will meet with the trial doctor to review additional details and ask remaining questions. Written information on the trial will be provided for their review as well as to share with their family and friends.

Upon agreeing to take part in the trial, participants will be given the informed consent form to sign. By signing this form, participants voluntarily consent to taking part in the trial. Even after they provide informed consent to participate, they are free to leave the trial at any time and for any reason.

What about side effects?

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, trial procedures may also involve certain risks. Trial participants will be informed about all of the trial drug’s known potential side effects and the trial’s procedures prior to their participation. Should additional risks be discovered during the course of the trial, participants will be immediately informed.

How long will participants take part in this trial?

Participants will take part in the BEACON-IPF trial for approximately 1 year. Participation in BEACON-IPF is voluntary with participants free to leave the trial at any time.

Will participants be compensated for participating in the trial?

BEACON-IPF trial participants will receive procedures including lab work, tests, trial visits, and trial drugs at no charge. Reimbursement to cover out-of-pocket expenses such as meals, transportation, and parking associated with site visits is available.

What is a “placebo”?

BEACON-IPF trial 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 trial doctor or trial staff will know whether the trial participant is receiving bexotegrast or placebo. In the case of an emergency, it is possible for the trial doctor to obtain this information.

What happens if the participant decides that they don’t want to stay in the trial?

Participation in the BEACON-IPF trial is voluntary. Participants are free to leave the trial 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.