NCT02614612

Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD

A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).

Conditions

• Graft-versus-host Disease (GVHD)

Interventions

Type	Name	Description
DRUG	Itacitinib (200 mg)
DRUG	Itacitinib (300 mg)
DRUG	prednisone or methylprednisolone (corticosteroids)	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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-06-01
• Completion: 2018-08-01
• First posted: 2015-11-25
• Last updated: 2019-03-08

Locations

23 sites across 1 country: United States