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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Trial Transparency email recommended (Toll free for US & Canada) 800-633-1610
contact-us@sanofi.com


Study Location:

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English | Cymraeg
Be Part of Research - Trial Details - 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.

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.

Recruiting

Open to: ALL

Age: 12.0 - N/A

Medical Conditions

Bronchiolitis Obliterans Syndrome
Graft vs Host Disease


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD.

The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jan 2024 Sep 2028

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Pharmaceutical form:Tablet-Route of administration:oral

Intervention Arm Group : Belumosudil;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form:Table-Route of administration:oral

Intervention Arm Group : Placebo;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form:Tablet-Route of administration:oral

Intervention Arm Group : Belumosudil;Placebo;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form:Tablet-Route of administration:oral

Intervention Arm Group : Belumosudil;Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Investigational Site Number : 8260001
    Manchester
    M20 4BX
  • Investigational Site Number : 8260003
    Leeds
    LS9 7TF
  • Investigational Site Number : 8260004
    Newcastle Upon Tyne
    NE7 7DN
  • Investigational Site Number : 8260006
    Cardiff
    Vale Of Glamorgan, The
    CF14 4XW
  • Investigational Site Number : 8260002
    London
    London, City Of
    SE5 9RL

Trial Transparency email recommended (Toll free for US & Canada) 800-633-1610
contact-us@sanofi.com



The study is sponsored by Sanofi




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Read full details for Trial ID: NCT06143891
Last updated 21 May 2025

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