GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Conditions

• Chronic Graft-versus-host Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Itacitinib — DRUG
  In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
• Placebo — DRUG
  In Part 2, participants will receive matching placebo.
• Methylprednisolone — DRUG
  Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
• Prednisone — DRUG
  Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.

Study Details

The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

Key Dates

Start date

Jan 17, 2019

Status verified

Oct 2025

Primary completion

Nov 3, 2023

Completion

Nov 3, 2023

Study Design

Enrollment

155 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 : Dose determination of itacitinib
  itacitinib administered in combination with corticosteroids.
• Experimental: Part 1 : Dose expansion of itacitinib
  itacitinib administered in combination with corticosteroids or corticosteroids alone.
• Placebo Comparator: Part 2 : itacitinib recommended dose from part 1
  itacitinib or placebo administered in combination with corticosteroids

Primary Outcome Measure

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: up to Day 28 ]

Locations (39)

Find similar trials in Tucson, AZ