This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to
receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance
immunosuppression or placebo (sterile normal saline) plus standard triple maintenance
immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids).
The primary objective is to test the hypothesis that treatment with triple maintenance
immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression
plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) listed for
re-transplantation, and c) death
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)