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

• Status: Completed
• Trial end date: 2020-07-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

• 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.