A Phase 1 interventional study of Itacitinib (200 mg) and Itacitinib (300 mg) in Graft-versus-host Disease (GVHD), sponsored by Incyte Corporation. Completed at 23 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Incyte Corporation · Phase 1, Interventional, and Treatment
To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 31 is below the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids)
Drug: Itacitinib (200 mg) · Drug: prednisone or methylprednisolone (corticosteroids)
Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids)
Drug: Itacitinib (300 mg) · Drug: prednisone or methylprednisolone (corticosteroids)
Also known as: INCB039110
Also known as: INCB039110
All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56.
Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events
Time frame: First dose of study drug to 30 days after the last dose of study drug
Overall Response Rate (ORR)
Time frame: Days 14, 28, 56 and 100
Maximum Observed Plasma Concentration (Cmax) of the two treatment groups Itacitinib
Time frame: Day 1 and Day 7
Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups Itacitinib
Time frame: Day 1 and Day 7
Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups Itacitinib
Time frame: Day 1 and Day 7
Minimum observed plasma concentration (Cmin) of the two treatment groups Itacitinib
Time frame: Day 1 and Day 7
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Incyte Corporation