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

Conditions

• Acute Graft-versus-host Disease

Eligibility Criteria

Sex

ALL

Age

28 Days - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Itacitinib — DRUG
  Phase 1: Itacitinib administered orally once daily at the protocol-defined dose according to age cohort, with dose reductions or modifications based on safety assessments. Phase 2: Itacitinib administered orally once daily at the recommended dose from Phase 1.
• Corticosteroids — DRUG
  Phase 1 and 2: Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of disease as outlined per local treatment guidelines as background treatment.

Study Details

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.

Key Dates

Start date

Dec 31, 2019

Status verified

Oct 2025

Primary completion

Feb 17, 2020

Completion

Feb 17, 2020

Study Design

Enrollment

2 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Itacitinib + Corticosteroids

Primary Outcome Measure

Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: up to 45 days ]

Locations (14)

Find similar trials in Duarte, CA

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