A Phase 2, Open-Label Study of Axatilimab With Ruxolitinib on Chronic Graft-Versus-Host Disease

• Research type

  Research Study

• Full title

  A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

• IRAS ID

  1010016

• Contact name

  LORI CHLYSTA

• Contact email

  RA@incyte.com

• Sponsor organisation

  Incyte Corporation

• Clinicaltrials.gov Identifier

  NCT06388564

• Research summary

  This is a Phase 2 study in participants with newly diagnosed moderate or severe chronic graft-versus-host disease. The participant can qualify to be enrolled in 1 of three treatment groups that include the following:
  • Group A: Axatilimab plus ruxolitinib
  • Group B: Ruxolitinib
  • Group C: Corticosteroids
  We expect about 120 participants to be enrolled in this Study including 40 in Group A, 40 in Group B and 40 in Group C.
  It is estimated that an individual will participate for up to 37 months, allowing 28 days for screening, a treatment period consisting of 28-day cycles, until treatment withdrawal criteria are met and for a maximum of 24 months (26 cycles), followed by 12 months for Follow Up, and if the patient is deriving benefit from the study treatment as determined by their study doctor at the end of this period, they may be offered the option to transition to a rollover study.

  Chronic graft-versus-host disease is a severe complication of allo-SCT that affects various organs, leading to a reduced quality of life. Standard initial treatment of moderate and severe cGVHD includes systemic corticosteroids at a prednisone dose ranging between 0.5 and 1 mg/kg. Treatment of cGVHD with systemic corticosteroids is often ineffective, with frequent incomplete responses and recurrences. Approximately 50% to 60% of patients with cGVHD will require a second-line treatment within 2 years. Additionally, prolonged systemic corticosteroid treatment is associated with significant adverse effects. The goal of this study is to increase improve the quality of life of patients by evaluating a new treatment regimen which can hopefully reduce the need for a second therapy at a later date and minimize the adverse events from corticosteroids by reducing the amount of time they are required.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  24/LO/0448

• Date of REC Opinion

  6 Aug 2024

• REC opinion

  Further Information Favourable Opinion