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

Part of paid clinical trials in Duarte, California.

Sponsor
Incyte Corporation
Study ID
NCT02614612
Phase
PHASE1
Status
Completed

Conditions

  • Graft-versus-host Disease (GVHD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib (200 mg) — DRUG
  • Itacitinib (300 mg) — DRUG
  • prednisone or methylprednisolone (corticosteroids) — DRUG
    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.

Study Details

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

Key Dates

Start date
Dec 31, 2015
Status verified
Mar 2019
Primary completion
Jun 30, 2016
Completion
Aug 31, 2018

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib (200 mg)
    Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids)
  • Experimental: Itacitinib (300 mg)
    Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids)

Primary Outcome Measure

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 ]

Locations (23)

FacilityCityStateZIPSite coordinators
-DuarteCalifornia--
-La JollaCalifornia--
-Los AngelesCalifornia--
-DenverColorado--
-Coral GablesFlorida--
-AtlantaGeorgia--
-ChicagoIllinois--
-Kansas CityKansas--
-WestwoodKansas--
-New OrleansLouisiana--
-BostonMassachusetts--
-DetroitMichigan--
-St LouisMissouri--
-OmahaNebraska--
-New YorkNew York--
-RochesterNew York--
-CincinnatiOhio--
-ClevelandOhio--
-PortlandOregon--
-HersheyPennsylvania--
-PittsburghPennsylvania--
-NashvilleTennessee--
-San AntonioTexas--

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