Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)

Summary

The primary objective of this study is to evaluate the effect of entospletinib (ENTO) on the best overall response rate in adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic corticosteroids as part of first-line therapy for cGVHD.

Timeline

Start

2016-05-27

Primary completion

2017-12-19

Completion

2018-03-06

Outcome

Missed primary endpoint

registry analysis (superiority test); ENTO vs Placebo; p = 0.99 NCT02701634 ↗

Drugs

Indications