GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

Graft-versus-host Disease (GVHD) Clinical Trial

Official title:
GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03139604
Study type	Interventional
Source	Incyte Corporation
Contact
Status	Completed
Phase	Phase 3
Start date	July 19, 2017
Completion date	July 13, 2020

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See also
Status	Clinical Trial	Phase
Completed	`NCT03112603` - A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)	Phase 3
Completed	`NCT02953678` - A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)	Phase 2
Completed	`NCT02614612` - Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD	Phase 1
Approved for marketing	`NCT03147742` - An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
Approved for marketing	`NCT05722912` - Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD