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 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.

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.

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.

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.

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.

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.

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.