70
Participants
Start Date
August 1, 2023
Primary Completion Date
December 31, 2025
Study Completion Date
June 30, 2026
Nintedanib
Nintedanib 150 mg BID
Placebo
Placebo comparator
Standard of Care
Maximum of 2 standard of care immunosuppressant (IS) drugs are allowed, one being a glucocorticoid (GC) and the other being a non-GC IS drug OR 2 non-GC IS drugs in the event that the patient is not on a GC). The patient should be on the IS drug(s) for at least 12 weeks (at least 4 weeks or more for GC) before the screening. The doses should be stable for at least 4 weeks (at least 2 weeks for GC) before the screening visit.
Columbia University Irving Medical Center, New York
Northwell Health, New York
University of Pittsburgh, Pittsburgh
University of South Florida, Tampa
University of Alabama, Birmingham
University of Chicago, Chicago
University of Kansas Medical Center, Kansas City
National Jewish Health, Denver
University of Utah Health Sciences Center, Salt Lake City
Mayo Clinic Arizona, Scottsdale
Collaborators (1)
Boehringer Ingelheim
INDUSTRY
Rohit Aggarwal, MD
OTHER