An Open-Label Single-Arm Phase 1 Study Evaluating Safety of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects

Incyte Corporation17 sites in 1 country14 target enrollmentMarch 20, 2018

ConditionsAcute Graft-versus-host Disease

InterventionsItacitinib Corticosteroid

DrugsItacitinib Corticosteroid

Overview

Phase: Phase 1
Intervention: Itacitinib
Conditions: Acute Graft-versus-host Disease
Sponsor: Incyte Corporation
Enrollment: 14
Locations: 17
Primary Endpoint: Number of treatment-emergent adverse events
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD).

Registry

clinicaltrials.gov

Start Date

March 20, 2018

End Date

February 17, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Incyte Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Japanese; subject was born in Japan and has not lived outside of Japan for a total of \> 10 years, and subject can trace maternal and paternal Japanese ancestry.
•Has undergone 1 allo-hematopoietic stem cell transplant (HSCT) from any donor and source (unrelated, sibling, haploidentical donors with any matching) using bone marrow, peripheral blood or cord blood for hematologic malignancies. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
•Clinically suspected Grades II to IV aGVHD as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, occurring after allo-HSCT and any anti-GVHD prophylactic medication.
•Evidence of myeloid engraftment (eg, absolute neutrophil count \[ANC\] ≥ 0.5 × 10\^9/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed.
•Female subjects should agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration if of childbearing potential or must have evidence of non-childbearing potential by fulfilling protocol-defined criteria at screening.

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 (defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection; persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection).
•Known human immunodeficiency virus infection.
•Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. For subjects with negative HBsAg and positive total hepatitis B core antibody and for subjects who are positive for HCV antibody, HBV DNA and HCV RNA must be undetectable upon testing.
•Evidence of relapsed primary disease or having been treated for relapse after the allo-HSCT was performed.
•Any corticosteroid therapy (for indication other than GVHD) at doses \> 1 mg/kg per day methylprednisolone or equivalent within 7 days of enrollment.
•Severe organ dysfunction unrelated to underlying GVHD, including the following:
•Cholestatic disorders or unresolved veno-occlusive disease of the liver.