Clinical Trial Results:
Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
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Summary
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EudraCT number |
2018-002253-30 |
Trial protocol |
GB FR DE ES IT |
Global end of trial date |
20 Feb 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Aug 2020
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First version publication date |
28 Aug 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
INCB 39110-120
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03721965 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Incyte Corporation
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Sponsor organisation address |
1801 Augustine Cut off, Wilmington, United States, 19803
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Public contact |
Incyte
Corporation Call Center, Incyte
Corporation, +44 (0)330 100 3677, globalmedinfo@incyte.com
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Scientific contact |
Incyte
Corporation Call Center, Incyte
Corporation, +44 (0)330 100 3677, globalmedinfo@incyte.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-002178-PIP01-17 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Feb 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Feb 2020
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.
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Protection of trial subjects |
The study was conducted in compliance with the ethical principles derived from the Declaration of Helsinki and the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of study participants were also followed during the conduct of the trial
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Dec 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 2
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Worldwide total number of subjects |
2
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
2
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study is conducted at 1 site in USA | ||||||||||||
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Pre-assignment
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Screening details |
2 participants were screened and enrolled in the study | ||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Itacitinib + Corticosteroids | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
itacitinib
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Investigational medicinal product code |
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Other name |
INCB039110
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
itacitinib was administered orally at 200 mg once daily
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Baseline characteristics reporting groups
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Reporting group title |
Itacitinib + Corticosteroids
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Itacitinib + Corticosteroids
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Reporting group description |
- | ||
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End point title |
Phase 1: Participants with treatment-emergent adverse events (TEAEs) [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Up to 12 months
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There is no hypothesis testing for this endpoint , descriptive analysis is provided. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Phase 1: Cmax of itacitinib when administered with corticosteroids [2] | ||||||||
End point description |
Maximum observed plasma concentration.
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End point type |
Primary
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End point timeframe |
Day 7
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to small sample size (n=2), PK data was not summarized. |
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| Notes [3] - Due to small sample size (n=2), PK data was not summarized |
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| No statistical analyses for this end point | |||||||||
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End point title |
Phase 1: Cmin of itacitinib when administered with corticosteroids [4] | ||||||||
End point description |
Minimum observed plasma concentration.
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End point type |
Primary
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End point timeframe |
Up to 28 days
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to small sample size (n=2), PK data was not summarized. |
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| Notes [5] - Due to small sample size (n=2), PK data was not summarized |
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| No statistical analyses for this end point | |||||||||
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End point title |
Phase 1: Tmax of itacitinib when administered with corticosteroids [6] | ||||||||
End point description |
Time to maximum concentration.
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End point type |
Primary
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End point timeframe |
Up to 28 days
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to small sample size (n=2), PK data was not summarized. |
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| Notes [7] - Due to small sample size (n=2), PK data was not summarized |
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| No statistical analyses for this end point | |||||||||
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End point title |
Phase 1: AUC of itacitinib when administered with corticosteroids [8] | ||||||||
End point description |
Area under the plasma concentration-time curve.
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End point type |
Primary
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End point timeframe |
Up to 28 days
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to small sample size (n=2), PK data was not summarized. |
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| Notes [9] - Due to small sample size (n=2), PK data was not summarized |
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| No statistical analyses for this end point | |||||||||
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End point title |
Phase 1: Cl/F of itacitinib when administered with corticosteroids [10] | ||||||||
End point description |
Apparent oral dose clearance.
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End point type |
Primary
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End point timeframe |
Up to 28 days
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Due to small sample size (n=2), PK data was not summarized. |
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| Notes [11] - Due to small sample size (n=2), PK data was not summarized |
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| No statistical analyses for this end point | |||||||||
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End point title |
Phase 1: Overall response rate | ||||||
End point description |
Defined as the proportion of participants demonstrating a CR, VGPR, or PR.
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End point type |
Secondary
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End point timeframe |
Day 28
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| Notes [12] - The study was terminated before participants reached Day 28, time point for analysis. |
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to 12 months
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.1
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Reporting groups
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Reporting group title |
Itacitinib + Corticosteroids
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Jan 2019 |
The primary purpose of this amendment (Protocol Amendment 2) was to add recommendations for concomitant administration of potent CYP3A4 inhibitors based on emergent data from the INCB 39110-108 study. Additional clarification on study procedures and other updates have also been included. |
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02 Jul 2019 |
The primary purpose of this amendment (Protocol Amendment 3) was to revise the toxicity monitoring and stopping boundaries. Eligibility criteria referring to renal and liver function have been modified to address comments the Health Authorities. Itacitinib clinical background has also been updated to align with the most recent data available. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
