Chicago, Illinois 60714

  • host Disease


The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).


Inclusion Criteria: - Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria - Underwent allogeneic stem cell transplantation (allo-HCT) - Karnofsky Performance Status score ≥ 60%. - Evidence of myeloid and platelet engraftment. - Willingness to avoid pregnancy or fathering children based on protocol-defined criteria. Exclusion Criteria: - Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD. - Has received any other systemic treatment for cGVHD, including extracorporeal photopheresis (ECP). - Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization. - cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. - Evidence of relapsed primary malignancy.



Primary Contact:

Study Director
Rodica Morariu-Zamfir, MD
Incyte Corporation

Incyte Corporation Call Center (US)
Phone: 1.855.463.3463

Backup Contact:

Incyte Corporation Call Center (ex-US)
Phone: +800 00027423

Location Contact:

Chicago, Illinois 60714
United States

Site Status: Recruiting

Data Source:

Date Processed: July 26, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.