Trial · NCT03139604

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

NCT03139604, Phase 3, Completed, Incyte Corporation; results first posted 2020-05-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease. Trials, record NCT03139604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03139604

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
NCT number: NCT03139604
Status: Completed
Phases: Phase 3
Enrollment: 439 participants, actual
Lead sponsor: Incyte Corporation
Conditions: Graft-versus-host Disease (GVHD)
Interventions: Itacitinib, Placebo, Prednisone, Methylprednisolone
First posted: 2017-05-04
Last updated: 2025-09-02
Other registries' IDs: eudract:2017-000538-78
Results first posted: 2020-05-15

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index	Day 28	Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
Secondary	Nonrelapse Mortality	Month 6,9,12 and 24	Defined as the percentage of participants who died due to causes other than malignancy relapse.
Secondary	Duration of Response	Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months	Defined as the interval from first response until GVHD progression or death.
Secondary	Cmax of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	Defined as maximum observed plasma concentration.
Secondary	Cmin of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	Defined as minimum observed plasma concentration.
Secondary	Tmax of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	Defined as time to maximum plasma concentration.
Secondary	AUC of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	Defined as area under the concentration-time curve.
Secondary	CL/F of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	Defined as oral dose clearance.
Secondary	Time to Response	End of Study, total particpation expected to average 24 months	Defined as the interval from treatment initiation to first response
Secondary	Relapse Rate of Malignant and Nonmalignant Hematologic Disease	Randomization through end of Study, study duration expected to average 24 months	Defined as the proportion of subjects whose underlying hematologic disease relapses

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index	Day 28	Full Analysis Set (FAS) Population	Percentage of Participants	NUMBER
SECONDARY	Nonrelapse Mortality	Month 6,9,12 and 24	Full Analysis Set (FAS) Population	participants	NUMBER
SECONDARY	Duration of Response	Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months	Full Analysis Set (FAS) Population	days	MEDIAN
SECONDARY	Cmax of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.	nM	MEAN
SECONDARY	Cmin of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7 as this is more representative of true steady state. Day 28 is positively biased as non responders are withdrawn from study by D28.	nM	MEAN
SECONDARY	Tmax of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.	hrs	MEDIAN
SECONDARY	AUC of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.	nM*h	MEAN
SECONDARY	CL/F of Itacitinib When Administered in Combination With Corticosteroids	Protocol-defined timepoints up to Day 28	All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.	L/h	MEAN
SECONDARY	Time to Response	End of Study, total particpation expected to average 24 months	Full Analysis Set (FAS) Population who were responders	days	MEAN
SECONDARY	Relapse Rate of Malignant and Nonmalignant Hematologic Disease	Randomization through end of Study, study duration expected to average 24 months	Full Analysis Set (FAS) Population	percentage	NUMBER

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group55

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index	Itacitinib Plus Corticosteroids		74.0	95% Confidence Interval 67.6 to 79.7	Percentage of Participants
Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index	Placebo Plus Corticosteroids		66.4	95% Confidence Interval 59.7 to 72.6	Percentage of Participants
Nonrelapse Mortality	Itacitinib Plus Corticosteroids	6 Months	36		participants
Nonrelapse Mortality	Placebo Plus Corticosteroids	6 Months	37		participants
Nonrelapse Mortality	Itacitinib Plus Corticosteroids	9 Months	46		participants
Nonrelapse Mortality	Placebo Plus Corticosteroids	9 Months	45		participants
Nonrelapse Mortality	Itacitinib Plus Corticosteroids	12 Months	51		participants
Nonrelapse Mortality	Placebo Plus Corticosteroids	12 Months	52		participants
Nonrelapse Mortality	Itacitinib Plus Corticosteroids	24 Months	56		participants
Nonrelapse Mortality	Placebo Plus Corticosteroids	24 Months	52		participants

1 to 10 of 55Source ClinicalTrials.gov

See all 55 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Itacitinib Plus Corticosteroids	219
Overall Study	STARTED	Placebo Plus Corticosteroids	220
Overall Study	COMPLETED	Itacitinib Plus Corticosteroids	0
Overall Study	COMPLETED	Placebo Plus Corticosteroids	0
Overall Study	NOT COMPLETED	Itacitinib Plus Corticosteroids	219
Overall Study	NOT COMPLETED	Placebo Plus Corticosteroids	220

Source ClinicalTrials.gov

Adverse events960

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Itacitinib Plus Corticosteroids	26	215	32
other	Abdominal pain	Gastrointestinal disorders	Placebo Plus Corticosteroids	26	216	28
other	Abdominal pain	Gastrointestinal disorders	Total	52	431	60
other	Acute kidney injury	Renal and urinary disorders	Itacitinib Plus Corticosteroids	11	215	13
other	Acute kidney injury	Renal and urinary disorders	Placebo Plus Corticosteroids	21	216	23
other	Acute kidney injury	Renal and urinary disorders	Total	32	431	36
other	Alanine aminotransferase increased	Investigations	Itacitinib Plus Corticosteroids	30	215	39
other	Alanine aminotransferase increased	Investigations	Placebo Plus Corticosteroids	21	216	23
other	Alanine aminotransferase increased	Investigations	Total	51	431	62
other	Anaemia	Blood and lymphatic system disorders	Itacitinib Plus Corticosteroids	63	215	80

1 to 10 of 960Source ClinicalTrials.gov

See all 960 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Itacitinib Plus Corticosteroids	69	215
Total, all-cause mortality	Placebo Plus Corticosteroids	69	216
Total, all-cause mortality	Total	138	431
Total, other adverse events	Itacitinib Plus Corticosteroids	207	215
Total, other adverse events	Placebo Plus Corticosteroids	206	216
Total, other adverse events	Total	413	431
Total, serious adverse events	Itacitinib Plus Corticosteroids	133	215
Total, serious adverse events	Placebo Plus Corticosteroids	131	216
Total, serious adverse events	Total	264	431

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34971577	DERIVED	PubMed
35689489	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Itacitinib Plus Corticosteroids vs Placebo Plus Corticosteroids: Incidence Rate of aGVHD Flares	Trial comparisons
Itacitinib Plus Corticosteroids vs Placebo Plus Corticosteroids: Number of Treatment-emergent Adverse Events With INCB39110	Trial comparisons
Itacitinib Plus Corticosteroids vs Placebo Plus Corticosteroids: Incidence Rate of Secondary Graft Failure	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03139604

GET https://conductscience.org/api/trials/v1/NCT03139604/results?page=2

API reference For AI assistants