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GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

NCT03584516•Incyte Corporation

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (133)

University of Arizona Cancer Center - Out Pt.

Tucson, Arizona, United States

University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute

Little Rock, Arkansas, United States

City of Hope National Medical Center

Duarte, California, United States

University of California San Diego Medical Center, Moores Cancer Center

La Jolla, California, United States

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Augusta University - Medical College of Georgia

Augusta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Illinois Cancer Specialists

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Key Dates

Start Date

January 17, 2019

Primary Completion Date

November 3, 2023

Completion Date

November 3, 2023

Last Updated

October 20, 2025

Enrollment

155

ACTUAL participants

Conditions

Chronic Graft-versus-host Disease

Interventions

Itacitinib

DRUG

Placebo

DRUG

Methylprednisolone

DRUG

Prednisone

DRUG

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

NCT06660355

Chronic Graft-versus-host Disease (cGVHD)

View study

ACTIVE_NOT_RECRUITING

Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

NCT02611180

Acute Graft-versus-host DiseaseAcute GVHD+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Inclusion Criteria

Exclusion Criteria

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

A Prospective Observational Study for Evaluating CGVHD

Imatinib Mesylate and Mycophenolate Mofetil for Steroid-Refractory Sclerotic/Fibrotic cGVHD in Children

Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD