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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.
Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Overall response rate based on Center for International Bloe index
Defined as the percentage of participants demonstrating a complete response (CR), very good partial responseod and Marrow Transplant Research (CIBMTR) respons (VGPR), or partial response (PR).
Time frame: 28 days
Nonrelapse mortality
Defined as the percentage of participants who died due to causes other than malignancy relapse
Time frame: Month 6
Duration of response
Defined as the interval from first response until GVHD progression or death.
Time frame: Baseline through 30-35 days after end of treatment, expected to average approximately 6 months
Cmax of itacitinib when administered in combination with corticosteroids
Defined as maximum observed plasma concentration.
Time frame: Protocol-defined timepoints up to Day 28
Cmin of itacitinib when administered in combination with corticosteroids
Defined as minimum observed plasma concentration
Time frame: Protocol-defined timepoints up to Day 28
Tmax of itacitinib when administered in combination with corticosteroids
Defined as time to maximum plasma concentration
Time frame: Protocol-defined timepoints up to Day 28
AUC(area under curve) of itacitinib when administered in combination with corticosteroids
Protocol-defined timepoints up to Day 28
Time frame: Protocol-defined timepoints up to Day 28
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CL/F(clearance) of itacitinib when administered in combination with corticosteroids
Defined as oral dose clearance
Time frame: Protocol-defined timepoints up to Day 28