Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Condition

Study Name

A Double Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) (IRB no. 47976)

Phase

Phase III

Summary

This study focuses on patients with progressive fibrosing interstitial lung disease (PF-ILD). The purpose of the study is to evaluate the investigational use of a drug called nintedanib. Researchers aim to determine how well nintedanib may help participants’ lung disease and will compare the safety and effects of nintedanib with placebo (inactive substance). The study involves two parts. The first part will evaluate the effectiveness and safety of nintedanib, and the second part will collect longer-term effectiveness and safety data of the drug.

Participants will be randomly assigned to receive either nintedanib or placebo. Nintedanib is approved by the U.S. Food and Drug Administration (FDA) to treat idiopathic pulmonary fibrosis. However, it is not approved by the FDA for progressive fibrosing interstitial lung disease.

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • Patients with physician-diagnosed interstitial lung disease (ILD) who fulfill at least one specific criteria for PF-ILD within 24 months of screening visit, despite treatment with unapproved medications used in clinical practice to treat ILD
  • Fibrosing lung disease on high resolution computed tomography

Key Exclusion Criteria

  • Previous treatment with nintedanib or pirfenidone
  • Aspartate aminotransferase, alanine aminotransferase >1.5 x upper limit of normal (ULN) at Visit 1
  • Bilirubin >1.5 x ULN at Visit 1
  • Women who are pregnant, nursing, or who plan to become pregnant while in the study

Please see detailed list of inclusion and exclusion criteria.

Principal Investigator

Jeremy Falk, MD

Contact

Susan Jackman
Phone: 310-423-4765
Email: susan.jackman@cshs.org