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

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 ]

Related Studies