GRAVITAS-309: Initial Treatment for Chronic Graft-Versus-Host Disease
Research type
Research Study
Full title
A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
IRAS ID
255759
Contact name
Adam Shilling
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2018-001606-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 30 days
Research summary
Incyte Corporation (“Sponsor”) is conducting this voluntarily study of an investigational drug (IMP) called itacitinib. Itacitinib (INCB039110) is an IMP that is being studied by for use in the treatment of moderate or severe chronic Graft-Versus-Host Disease (cGVHD).
The Sponsor is trying to find out whether itacitinib in combination with corticosteroids is more effective than the drugs which doctors would normally prescribe for this condition to improve treatments for patients with cGVHD.
cGVHD is a condition where the immune cells from the donor recognise the transplant recipient as foreign following allogeneic haematopoietic stem cell transplantation (allo-HCT). This leads to an increased inflammatory response. The IMP, inhibits specific proteins involved in signalling, and aims to reduce inflammatory response. Corticosteroids are also a type of treatment commonly used to reduce swelling and suppress the immune system. It is hoped that the IMP combined with Corticosteroids will have have a more successful response than current treatment methods.
Male’s or female’s aged 18 years or older with active clinical diagnosis of moderate or severe cGVHD are eligible. Approximately 266 participants with cGVHD will be participating at approximately 131 study centres around the world. In the UK the study will be conducted in NHS Hospitals in England and Wales.
In Part 1, a total of 20 participants (globally) with moderate or severe cGVHD will be randomised 1:1 to itacitinib 200 mg plus corticosteroids once daily, or 300 mg plus corticosteroids one daily. Itacitinib treatment will continue until treatment failure.
Part 2 will include 236 participants (118 per treatment group). Groups include a placebo control group, or treatment group containing a dose determined from results of Part 1.
Participants will remain on study for a total of 36 months.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0028
Date of REC Opinion
7 May 2019
REC opinion
Further Information Favourable Opinion