GRAVITAS-301 Treatment of First-Line Acute Graft Versus-Host Disease

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft Versus-Host Disease

• IRAS ID

  228262

• Contact name

  Adrian Bloor

• Contact email

  adrian.bloor@christie.nhs.uk

• Sponsor organisation

  Incyte Biosciences UK Ltd

• Eudract number

  2017-000538-78

• Duration of Study in the UK

  2 years, 4 months, 11 days

• Research summary

  Acute Graft versus Host Disease (aGvHD) is a serious complication of allogeneic (donor) stem cell transplantation. Patients developing aGvHD are treated with corticosteroids but about half require additional therapy. This study is investigating the use of Itacitinib in combination with corticosteroids, to evaluate if it is safe and effective in patients with aGVHD.
  
  The study will be performed in 24 countries in approximately 100 hospitals or clinics
  
  Trial participants will receive one of two treatments below:
  
  1. Itacitinib in combination with corticosteroids
  2. Placebo in combination with corticosteroids

  The study is randomised meaning this is randomly allocated and neither the participant, their doctor or trial team can choose which treatment is assigned. The Itacitinib and Placebo are both taken as tablets. The placebo tablets look similar to the Itacitinib tablets although don't contain any active medication. All participants in the study will continue to receive corticosteroids and other medication as directed by their own doctor.
  
  The Study will continue until one of the following occurs:

  • The GvHD has progressed
  • The participant decide to no longer participate
  • The participant's Doctor determines the patient should no longer receive the trial medication due to side effects or for other reasons
  • The trial ends or is closed early
  • The participant become pregnant or inform the Study Doctor that intend to become pregnant
  
  Trial participants will be followed up weekly for 8 weeks, and then 4-weekly whilst they continue on study medication and followed up every 8 weeks after completing treatment to the end of trial.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  17/SC/0408

• Date of REC Opinion

  18 Sep 2017

• REC opinion

  Further Information Favourable Opinion