Participating in BUILD-3

BUILD 3 stands for Bosentan Use in Interstitial Lung Disease. It is a clinical research study designed to determine whether an investigational drug called bosentan may help people with idiopathic pulmonary fibrosis (IPF). Idiopathic means that the cause of the disease is not known. Investigational drug means that the drug is not yet approved to treat this disease. This is why it is being studied in a clinical trial to determine its efficacy and safety in treating this disease.

Enrolling in a clinical study is a very important decision, and there are many issues to consider including risks and benefits. Here are a few questions you might ask if you're considering taking part in BUILD 3.

Who is the sponsor for BUILD 3?

Actelion Pharmaceuticals Ltd. is the sponsor of the BUILD 3 study and the headquarters are based in Basel, Switzerland, although it has offices in many countries around the world including North America, Europe and the Far East.

What is the objective of BUILD 3?

BUILD 3 is a clinical study that is designed to determine if the investigational drug bosentan may be effective and safe for the treatment of idiopathic pulmonary fibrosis.

Who can participate?

BUILD 3 is a clinical study and has strict rules regarding who can participate. These rules are called exclusion and inclusion criteria. Before enrolling, it's important to talk with your doctor to see if you meet the guidelines set by the study investigators. You can learn more by reviewing the complete list of criteria with your doctor. The complete list can be found at www.clinicaltrials.gov

How does a clinical study work?

BUILD 3 is a randomized, placebo-controlled study. This means that patients are randomly divided into separate groups that either receives the investigational drug (bosentan) or a placebo (a pill without the active drug in it). This is done so that investigators can effectively determine how well a drug works. In this study there are 2 groups: the treatment group and the placebo group - two thirds of the patients will receive bosentan and one third will receive placebo. A placebo group is an essential part of a well-controlled study because it allows the study investigators to determine the efficacy and the safety of the investigational drug compared with placebo by looking at specific outcomes of the patients in both groups. Neither you nor your doctor will know whether you received bosentan or placebo until the study is finished and the results are published.

What are the benefits of participating? What are the risks?

BUILD 3 is a randomized, placebo-controlled study. This means that patients are randomly divided into separate groups that either receives the investigational drug (bosentan) or a placebo (a pill without the active drug in it). This is done so that investigators can effectively determine how well a drug works. In this study there are 2 groups: the treatment group and the placebo group - two thirds of the patients will receive bosentan and one third will receive placebo. A placebo group is an essential part of a well-controlled study because it allows the study investigators to determine the efficacy and the safety of the investigational drug compared with placebo by looking at specific outcomes of the patients in both groups. Neither you nor your doctor will know whether you received bosentan or placebo until the study is finished and the results are published.

What are the benefits of participating? What are the risks?

Participating in a clinical trial is one way to gain access to an investigational drug. During the clinical study, you have the opportunity to receive expert medical care from some of the leading doctors in the treatment of idiopathic pulmonary fibrosis. Keep in mind that no clinical trial is without risk. The therapy in this clinical trial is intended for use by specialized doctors in structured settings. It may not prove to be more effective than standard treatment, and you may experience unpleasant or harmful side effects. In addition, you may be put in the placebo group and will not receive the study drug. It's important to discuss the benefits and risks with your doctor and loved ones before making the decision to enroll.

Will I have to travel?

Participating in BUILD 3 means you will have to attend scheduled appointments with your study investigator. You can find the trial site nearest you on the list of trial sites or at www.clinicaltrials.gov (type 'BUILD 3' into the search box). If there isn't a trial site in your area, be sure to factor in the issue of travel as you consider whether to enroll in the trial.

How are human subjects protected in clinical trials?

Patients' rights such as data confidentiality and safety are protected. The study investigator must obtain approval from an Institutional Review Board or an Independent Ethics committee before conducting the study. This is a committee which evaluates the study protocol to ensure that the patient's rights are protected and the study does not present an undue or unnecessary risk to the patient. Patients will have to read and sign an “informed consent” form before they participate in the study. The informed consent form provides the details of the study, including any known risks that may be involved.

Learn More

For the most up to date list of trial sites please go to www.clinicaltrials.gov and type 'BUILD 3' into the search box. If you need further assistance after checking this site, please contact medinfo@actelion.com.

BUILD-3 Trial Summary

Trial Objective

BUILD-3 is a morbidity and mortality study designed to investigate the efficacy and safety of bosentan in patients with IPF. The primary objective is to evaluate the effect of bosentan on time to disease worsening or death in patients with IPF. Secondary objectives are to assess the effects of bosentan on quality of life, dyspnea, and pulmonary function, and to assess safety and tolerability.

Study Groups

BUILD 3 is a randomized, placebo controlled trial. This means that patients will be separated into 2 groups: placebo and treatment, as described in “How does a clinical study work?” above. The treatment group will have twice as many patients as the placebo group. The trial will have: Approximately 100 centers in 20 countries 390 patients in 2 groups 130 in placebo arm 260 in bosentan arm

Eligibility Criteria

BUILD 3 has strict rules regarding who can participate, these are called inclusion and exclusion criteria. There are 3 key inclusion criteria for BUILD 3; You must be at least 18 years of age You must have proven IPF diagnosis determined with a surgical lung biopsy You must have had the disease for 3 years or less There are also criteria that will mean you cannot take part in the study. These are called exclusion criteria and they include among other things; Having another lung disease in addition to IPF and Being enrolled in another clinical trial

All of the exclusion and inclusion criteria in the study can be reviewed on the website www.clinicaltrials.gov (enter 'BUILD 3' into the search box).