CELGENE Study

Condition: Idiopathic pulmonary fibrosis

Eligibility

Key Inclusion Criteria

  • ≥40 years old
  • Diagnosed with IPF within four years of screening
  • Diagnosis of IPF is supported by high resolution computed tomography and historical surgical lung biopsy

Key Exclusion Criteria

  • Has any significant medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from participating in the study
  • Has any condition including the presence of laboratory abnormalities
  • Pregnant or lactating

Full Study Name

A Phase II, 24-Week Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With IPF, Followed by a 28-Week Treatment Extension (IRB no. 47812)

Summary

The purpose of this study is to determine the effects of an investigational drug called CC-90001 on patients diagnosed with idiopathic pulmonary fibrosis (IPF), a condition in which scarring of the lungs occurs. Participants will be randomly assigned to receive CC-90001 or placebo (inactive substance). Researchers will assess the effect of CC-90001 on improving IPF, in addition to how well the body tolerates the drug. Another purpose of the study is to determine whether a biomarker test can show how IPF is affected by CC-90001 in a specific group of cells in the body. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease.

Phase

Phase II

Principal Investigator

Jeremy Falk, MD

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