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 Graft-Versus-Host Disease

  • STATUS
    Recruiting
  • sponsor
    Incyte
Updated on 8 December 2020
graft-versus-host disease

Summary

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 Graft-Versus-Host Disease

Description

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).

For more information, please contact Incyte Corporation at 1.855.463.3463

Details
Condition Graft-Versus-Host Disease, Graft-Versus-Host Disease (GVHD)
Clinical Study IdentifierTX151481
SponsorIncyte
Last Modified on8 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Do you have Graft-Versus-Host Disease?
Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible
Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen
Evidence of myeloid engraftment. Use of growth factor supplementation is allowed
Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockroft Gault equation
Willing to avoid pregnancy or fathering children
Able to give written informed consent and comply with all study visits and procedures
Able to swallow and retain oral medication

Exclusion Criteria

Has received more than 1 allo-HSCT
Has received more than 2 days of systemic corticosteroids for aGVHD
Presence of GVHD overlap syndrome
Presence of an active uncontrolled infection
Known human immunodeficiency virus infection
Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation
Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed
Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization
Severe organ dysfunction unrelated to underlying GVHD, including: Cholestatic disorders or unresolved veno-occlusive disease of the liver
Clinically significant or uncontrolled cardiac disease
Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen
Currently breast feeding
Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted
Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment
Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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