A Study of IBI377 in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
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Updated on 16 February 2024
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cancer
corticosteroids
growth factor
stem cell transplantation
graft versus host disease
hematologic malignancy
acute graft versus host disease
itacitinib

Summary

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

Description

This is an open label, single-arm, multicenter Phase I/II study of IBI377 in combination with corticosteroids as first-line treatment of subjects with Grade II to IV aGVHD. In Phase I, the PK, safety, tolerability and efficacy of IBI377 will be assessed in 12 subjects. In Phase II, the efficacy and safety will be assessed in 48 subjects.

Details
Condition GVHD,Acute
Age 18years - 100years
Treatment Methylprednisolone, Prednisone, Itacitinib
Clinical Study IdentifierNCT04220632
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Has undergone 1 allo-HSCT(hematopoietic stem cell transplantation) from any donor (related or unrelated with any degree of HLA(human leukocyte antigen) 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 acute-GVHD
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 (HCV) 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(Janus kinase) 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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