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A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

GVHD,Acute Clinical Trial

Official title:
An Open Label, Multicenter, Phase I/II Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

Clinical Trial Summary

The purpose of this study is to evaluate itacitinib in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

Clinical Trial Description

This is an open label, single-arm, multicenter Phase I/II study of IBI377 in combination with corticosteroids as first-line treatment of subjects with Grade II to IV aGVHD. In Phase I, the PK, safety, tolerability and efficacy of IBI377 will be assessed in 12 subjects. In Phase II, the efficacy and safety will be assessed in 48 subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04220632
Study type Interventional
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date June 18, 2020
Completion date October 10, 2020
View Details
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