Trial · NCT03721965

Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects

NCT03721965, Phase 1, Phase 2, Terminated, Incyte Corporation; results first posted 2023-02-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects. Trials, record NCT03721965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03721965

On this page

Trial

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

Title: Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
NCT number: NCT03721965
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 2 participants, actual
Lead sponsor: Incyte Corporation
Conditions: Acute Graft-versus-host Disease
Interventions: Itacitinib, Corticosteroids
First posted: 2018-10-26
Last updated: 2025-11-04
Other registries' IDs: eudract:2018-002253-30
Results first posted: 2023-02-21

Source ClinicalTrials.gov

Registered outcomes29

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

List	Outcome	Time frame	Description
Primary	Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	up to 45 days	A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug.
Primary	Phase 1: Cmax of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	Cmax was defined as the maximum observed plasma concentration.
Primary	Phase 1: Cmin of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	Cmin was defined as the minimum observed plasma concentration.
Primary	Phase 1: Tmax of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	Tmax was defined as the time to the maximum concentration.
Primary	Phase 1: AUC of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	AUC was defined as the area under the plasma concentration-time curve.
Primary	Phase 1: Cl/F of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	Cl/F was defined as the apparent oral dose clearance.
Primary	Phase 2: Overall Response Rate up to Day 28	up to Day 28	Overall response rate was defined as the number of participants demonstrating a complete response (CR), a very good partial response (VGPR), or a partial response (PR).
Secondary	Phase 2: Number of Participants With TEAEs	up to 12 months	A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug.
Secondary	Phase 2: Cmax of Itacitinib When Administered With Corticosteroids	Day 7: predose; 1, 2, and 4 hours post-dose	Cmax was defined as the maximum observed plasma concentration.
Secondary	Phase 2: Cmin of Itacitinib When Administered With Corticosteroids	Day 7: predose; 1, 2, and 4 hours post-dose	Cmin was defined as the minimum observed plasma concentration.

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	up to 45 days	All enrolled participants	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase 1: Cmax of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy.
PRIMARY	Phase 1: Cmin of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy.
PRIMARY	Phase 1: Tmax of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy.
PRIMARY	Phase 1: AUC of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy.
PRIMARY	Phase 1: Cl/F of Itacitinib When Administered With Corticosteroids	Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose	Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy.
PRIMARY	Phase 2: Overall Response Rate up to Day 28	up to Day 28	No participants enrolled in Phase 2 due to early termination of the study.
SECONDARY	Phase 2: Number of Participants With TEAEs	up to 12 months	No participants enrolled in Phase 2 due to early termination of the study.
SECONDARY	Phase 2: Cmax of Itacitinib When Administered With Corticosteroids	Day 7: predose; 1, 2, and 4 hours post-dose	No participants enrolled in Phase 2 due to early termination of the study.
SECONDARY	Phase 2: Cmin of Itacitinib When Administered With Corticosteroids	Day 7: predose; 1, 2, and 4 hours post-dose	No participants enrolled in Phase 2 due to early termination of the study.

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group1

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

Outcome	Group	Category	Value	Spread	Units
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Cohort 1 : Itacitinib + Corticosteroids		2		Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1 : Itacitinib + Corticosteroids	2
Overall Study	COMPLETED	Cohort 1 : Itacitinib + Corticosteroids	0
Overall Study	NOT COMPLETED	Cohort 1 : Itacitinib + Corticosteroids	2

Source ClinicalTrials.gov

Adverse events25

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	Anemia	Blood and lymphatic system disorders	Cohort 1 : Itacitinib + Corticosteroids	1	2	1
other	Neutropenia	Blood and lymphatic system disorders	Cohort 1 : Itacitinib + Corticosteroids	1	2	2
other	Diarrhoea	Gastrointestinal disorders	Cohort 1 : Itacitinib + Corticosteroids	1	2	1
other	Oedema peripheral	General disorders	Cohort 1 : Itacitinib + Corticosteroids	1	2	1
other	Ejection fraction decreased	Investigations	Cohort 1 : Itacitinib + Corticosteroids	1	2	1
other	Neutrophil count decreased	Investigations	Cohort 1 : Itacitinib + Corticosteroids	1	2	1
other	White blood cell count decreased	Investigations	Cohort 1 : Itacitinib + Corticosteroids	1	2	1
other	Hypertriglyceridaemia	Metabolism and nutrition disorders	Cohort 1 : Itacitinib + Corticosteroids	1	2	1
other	Arthralgia	Musculoskeletal and connective tissue disorders	Cohort 1 : Itacitinib + Corticosteroids	1	2	2
other	Back pain	Musculoskeletal and connective tissue disorders	Cohort 1 : Itacitinib + Corticosteroids	1	2	2

1 to 10 of 25Source ClinicalTrials.gov

See all 25 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1 : Itacitinib + Corticosteroids	1	2
Total, other adverse events	Cohort 1 : Itacitinib + Corticosteroids	2	2
Total, serious adverse events	Cohort 1 : Itacitinib + Corticosteroids	2	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT03721965

GET https://conductscience.org/api/trials/v1/NCT03721965/registered?page=2

API reference For AI assistants