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Terminated Phase 2Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03584516

Public ClinicalTrials.gov record NCT03584516. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03584516
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Incyte Corporation
Industry
Enrollment
155 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 16, 2019
Primary completion
Nov 2, 2023
Completion
Nov 2, 2023
Last update posted
Oct 19, 2025

2019 – 2023

United States locations

U.S. sites
39
U.S. states
23
U.S. cities
33
Facility City State ZIP Site status
University of Arizona Cancer Center - Out Pt. Tucson Arizona 85724
University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute Little Rock Arkansas 72205
City of Hope National Medical Center Duarte California 91010
University of California San Diego Medical Center, Moores Cancer Center La Jolla California 92093
University of Miami Sylvester Comprehensive Cancer Center Miami Florida 33136-1002
Winship Cancer Institute of Emory University Atlanta Georgia 30322
Augusta University - Medical College of Georgia Augusta Georgia 30912
Rush University Medical Center Chicago Illinois 60612
Illinois Cancer Specialists Chicago Illinois 60714
Loyola University Medical Center Maywood Illinois 60153-3328
Advocate Lutheran General Hospital - Oncology Specislists Sc Park Ridge Illinois 60028
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana 46202-5201
University of Kansas Hospital Authority Westwood Kansas 66160
Tulane University New Orleans Louisiana 70112-2618
University of Maryland - Greenebaum Cancer Center Baltimore Maryland 21201
Tufts Medical Center Boston Massachusetts 02111-1552
Massachusetts General Hospital Boston Massachusetts 02114
University of Michigan Ann Arbor Michigan 48109
Henry Ford Health System Detroit Michigan 48202
Spectrum Health Grand Rapids Michigan 49503
University of Minnesota, Masonic Cancer Center Minneapolis Minnesota 55455
Saint Louis University Cancer Center St Louis Missouri 63110
Hackensack University Medical Center Hackensack New Jersey 07601-8550
University of Rochester, James P. Wilmot Cancer Center Rochester New York 14642-0001
Stony Brook University Medical Center Stony Brook New York 11794
Duke University Medical Center Durham North Carolina 27710
Oncology Hematology Care, Inc Cincinnati Ohio 45236
University Hospitals Cleveland Medical Center Cleveland Ohio 44106-1716
University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania 19104
Jefferson University Hospitals Philadelphia Pennsylvania 19107
Western Pennsylvania Hospital Pittsburgh Pennsylvania 15224
University of Pittsburgh Pittsburgh Pennsylvania 15232-1309
Avera Cancer Institute Sioux Falls South Dakota 57105-2108
Tri Star Bone Marrow Transplant Nashville Tennessee 37203
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232
St David'S South Austin Medical Center Austin Texas 78704
Texas Oncology - Medical City Dallas Dallas Texas 75230
Texas Oncology - Baylor Sammons Cancer Center Dallas Texas 75246
Fred Hutchinson Cancer Research Center Seattle Washington 98109

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 94 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03584516, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 19, 2025 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03584516 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →