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A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

Testing Belumosudil with steroids for chronic Graft Versus Host Disease.

Recruiting
12 years and older
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is testing a medicine called Belumosudil with another medicine called corticosteroids to treat chronic Graft Versus Host Disease (cGVHD), a condition where a donated organ or bone marrow attacks your body. The study is for people aged 12 and older who have just been diagnosed with medium to severe cGVHD.

Participants will need to be screened for up to 4 weeks and then stay in the study until their cGVHD gets worse, or they can't tolerate the treatment. There will be a follow-up for at least 30 days after treatment to check for any side effects.

  • The study can last up to 5 years.
  • Participants must not have had any previous systemic treatment for cGVHD, except corticosteroids.
  • Women who are pregnant or breastfeeding cannot join.

If you join the study, you must agree to use contraception and be able to swallow tablets. The study aims to help find a better treatment for cGVHD, but there are risks of side effects from the medicine. Make sure to talk to your doctor to see if participating is right for you.

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Study details
    Chronic Graft Versus Host Disease

NCT06143891

Sanofi

12 April 2025

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