Clinical Trial: GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graf

Brief Summary: The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

Detailed Summary:
Sponsor: Incyte Corporation

Current Primary Outcome: Overall response rate based on Center for International Blood and Marrow Transplant Research (CIBMTR) response index [ Time Frame: Day 28 ]

Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Nonrelapse mortality [ Time Frame: Month 6 ]
    Defined as the percentage of participants who died due to causes other than malignancy relapse.
  • Duration of response [ Time Frame: Baseline through 30-35 days after end of treatment, expected to average approximately 6 months ]
    Defined as the interval from first response until GVHD progression or death.
  • Cmax of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]
    Defined as maximum observed plasma concentration.
  • Cmin of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]
    Defined as minimum observed plasma concentration.
  • Tmax of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]
    Defined as time to maximum plasma concentration.
  • AUC of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]
    Defined as area under the concentration-time curve.
  • CL/F of itacitinib when administered in combination with corticosteroids [ Time Frame: Protocol-defined timepoints up to Day 28 ]
    Defined as oral dose clearance.


Original Secondary Outcome: Same as current

Information By: Incyte Corporation

Dates:
Date Received: May 2, 2017
Date Started: June 2017
Date Completion: March 2020
Last Updated: May 2, 2017
Last Verified: May 2017