Clinical Trials /

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

NCT03584516

Description:

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).

Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
  • Official Title: GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Clinical Trial IDs

  • ORG STUDY ID: INCB 39110-309
  • NCT ID: NCT03584516

Conditions

  • Chronic Graft-versus-host Disease

Interventions

DrugSynonymsArms
ItacitinibINCB039110Part 1 : Dose determination of itacitinib
PlaceboPart 1 : Dose expansion of itacitinib
MethylprednisoloneMedrol, Medrol Dosepak, Solu-MedrolPart 1 : Dose determination of itacitinib
PrednisoneDeltasone, Prednicot, predniSONE Intensol, Rayos, Sterapred, Sterapred DSPart 1 : Dose determination of itacitinib

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Part 1 : Dose determination of itacitinibExperimentalitacitinib administered in combination with corticosteroids.
  • Itacitinib
  • Methylprednisolone
  • Prednisone
Part 1 : Dose expansion of itacitinibExperimentalitacitinib administered in combination with corticosteroids or corticosteroids alone.
  • Itacitinib
  • Placebo
  • Methylprednisolone
  • Prednisone
Part 2 : itacitinib recommended dose from part 1Placebo Comparatoritacitinib or placebo administered in combination with corticosteroids
  • Itacitinib
  • Methylprednisolone
  • Prednisone

Eligibility Criteria

        Inclusion Criteria:

          -  Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria

          -  Underwent allogeneic stem cell transplantation (allo-HCT)

          -  Karnofsky Performance Status score ≥ 60%.

          -  Evidence of myeloid and platelet engraftment.

          -  Willingness to avoid pregnancy or fathering children based on protocol-defined
             criteria.

        Exclusion Criteria:

          -  Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD.

          -  Has received any other systemic treatment for cGVHD, including extracorporeal
             photopheresis (ECP).

          -  Prior treatment with a Janus kinase (JAK) inhibitor for acute GVHD, unless the
             participant achieved complete or partial response and has been off JAK inhibitor
             treatment for at least 8 weeks before randomization.

          -  cGVHD occurring after a nonscheduled donor lymphocyte infusion (DLI) administered for
             pre-emptive treatment of malignancy recurrence.

          -  Evidence of relapsed primary malignancy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1 : Dose Determination: Number of dose-limiting toxicities
Time Frame:28 days
Safety Issue:
Description:To identify an appropriate dose of itacitinib in combination with corticosteroids as initial treatment for moderate or severe cGVHD.

Secondary Outcome Measures

Measure:Part 1, 1 expansion, and Part 2: Cmax of itacitinib when administered in combination with corticosteroids
Time Frame:Up to 28 days
Safety Issue:
Description:Maximum observed concentration.
Measure:Part 1, 1 expansion, and Part 2: Cmin of itacitinib when administered in combination with corticosteroids
Time Frame:Up to 28 days
Safety Issue:
Description:Minimum observed plasma or serum concentration over the dose interval.

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Graft-versus-host-disease
  • itacitinib
  • Janus kinase inhibitor
  • corticosteroids

Last Updated

October 27, 2020