A Phase II Randomized Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients with Idiopathic Pulmonary Fibrosis
ID Number 13-1749Principal Investigator(s)
Maria L Padilla
Department(s) or Division(s)
Pulmonary, Critical Care and Sleep Medicine
The purpose of this study is to find out what effects good or bad lebrikizumab or placebo treatment has on subjects and their Idiopathic Pulmonary Fibrosis (IPF). Lebrikizumab is considered “investigational” because it has not been approved by the U.S. Food and Drug Administration (FDA) for doctors to prescribe to their patients and it has not been used in patients with IPF before. Lebrikizumab is an antibody that is dissolved in a solution like water that can be injected under the skin. This type of injection is known as a subcutaneous injection. Lebrikizumab attaches to interleukin-13 (IL-13 for short). Many doctors believe IL-13 plays a part in IPF. Blocking IL-13 might slow down lung fibrosis and prevent the disease from getting worse but this is unknown at this time.
We will examine whether or not lebrikizumab reduces the loss of lung function the need for hospitalization or death caused by IPF compared with the placebo solution. The placebo is made of the same liquid solution that lebrikizumab is dissolved in but contains no protein or study drug. In this study subjects will get either lebrikizumab or placebo. Placebo is not expected to provide any benefit for subject's IPF.
Subjects will be randomized (assigned) to one of two treatment groups: 250 mg lebrikizumab or placebo. A computer program will randomly assign them to one of these two treatment groups. Neither the subject nor their doctor may choose the group they will be in. Subjects have a 50% chance of receiving lebrikizumab. The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is 250.
Recruiting Patients: No