INCB 39110-309 (GRAVITAS)

A phase 3 study of Itacitinib or Placebo in combination with corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Study Treatments

Itacitinib/placebo

Inclusion criteria

• Age >/= 18 years
• Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria
• Underwent allo-HCT from any donor HLA type using any graft source. Recipients of myeloablative or reduced intensity conditioning are eligible. 
• Evidence of myeloid and platelet engraftment.

Exclusion criteria

• Has received more than 1 allo-HSCT.
• Has received more than 3 days of systemic corticosteroids for acute-GVHD.
• Prior treatment with JAK inhibitor for aGVHD

Participating sites 

• AZ Delta Roeselare
• ZNA Stuivenberg
• Institut Jules Bordet
• UZA
• UZ Gent
• CHU Luik
• University Hospital Leuven Gasthuisberg