This study will evaluate the safety and effects of using nintendanib over 18 months in subjects with systemic sclerosis (SSc) and associated Interstitial Lung Disease 18 years old and older.This study will also see if treatment with nintedanib for SSc can slow the rate of lung scarring (fibrosis).
The purpose of this study is to find out what effects, good or bad, lebrikizumab or placebo treatment has on the subject and IPF.
Lebrikizumab is an antibody that is dissolved in a solution like water that can be injected under 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.
The study 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 drug. Placebo is not expected to provide any benefit for IPF. The study team will also examine whether or not treatment with lebrikizumab has an effect on symptoms of IPF like shortness of breath, as well as what negative effects the drug may have on patients with IPF. The study is also studying whether a new blood test to measure the level of a protein in blood called periostin can be used to determine which patients are more likely to benefit from lebrikizumab treatment.