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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT04220632
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • GVHD,Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
  • Prednisone — DRUG
    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.
  • Methylprednisolone — DRUG
    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.

Study Details

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).

Key Dates

First listed
Jan 7, 2020
Start date
Jun 18, 2020
Status verified
Oct 2020
Primary completion
Oct 10, 2020
Completion
Oct 10, 2020

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib+corticosteroids
    Itacitinib administered in combination with corticosteroids

Primary Outcome Measure

Overall response rate based on Center for International Bloe index [ Time Frame: 28 days ]

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