A randomized, double-blind 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.
Study on Investigational Medication for Chronic Graft Versus Host Disease (cGVHD)
Study Overview
This study is looking for individuals at least 12 years of age with newly diagnosed graft versus host disease after cell transplantation. Chronic graft versus host disease (cGVHD) is an immune-mediated and fibrotic disorder involving many organs, where the transplanted donor cells attack the transplant recipient’s body, after a stem cell or bone marrow transplant.
This study will help to find out if adding the investigational medication to your usual treatment (corticosteroid) is better, the same, or worse. The investigational medication (Belumosudil) is an oral medicine that reduces the immune reactions caused by the donor cells derived from the transplant. These immune reactions induce inflammation that damages normal tissues and promote scarring of the tissues to cause cGVHD. By reducing the immune reactions, the investigational medication may help to decrease symptoms of cGVHD.
Sanofi believes that everyone should have the opportunity to take part in clinical trials. It is important to include people who have been historically under-represented in clinical trials. Sanofi is committed to inclusivity in our studies.
If you are interested in learning more about this study, we encourage you to complete a brief questionnaire to help determine if you may qualify to participate and be referred to a site recruiting in your area for further evaluation.
Study Details
This study will include 260 participants across more than 20 countries and approximately 162 study sites around the world.
All participants will have a 50% chance of receiving a corticosteroid in combination with the investigational medication or a 50% chance of receiving a corticosteroid in combination with a placebo. There are many different corticosteroids, but the ones used in this study are either prednisone or prednisolone.
This study is a double-blind study, meaning neither the people taking part nor the study doctors know who is given the investigational medicine or the placebo. A placebo is an inactive substance that looks like the medicine but does not contain any medicine.
The study will last approximately 5 years. You will be required to come to a study site for a visit about every four (4) weeks initially, then every 8 weeks (2 months) and finally every 12 weeks (3 months). Study assessments include:
- Physical exam
- Vital signs
- Medical history
- Transplant and GVHD history
- GVHD severity assessment
- cGVHD activity assessment
- Lung function tests
- Electrocardiogram (ECG)
- Blood and urine tests
- Health questionnaires
There is no cost to participate. All study-related exams, study-related medications and study-related medical care are provided. There is no insurance required to take part in this study. You may be compensated for time and travel.
Eligibility Criteria
This study investigates chronic graft versus host disease (cGVHD), a condition that occurs after a stem cell or bone marrow transplant where the donor cells attack the recipient's body. The purpose of this study is to see if adding an investigational medication to the usual treatment with corticosteroids can improve outcomes for patients with cGVHD.
Participants will receive either a combination of corticosteroids and the investigational medication or corticosteroids and a placebo. The study is double-blind, meaning neither the participants nor the doctors know who receives the investigational medication. Procedures include physical exams, vital sign checks, and various assessments such as lung function tests and blood tests.
- Who can participate: Individuals aged 12 years and older with chronic graft versus host disease may participate. All genders are eligible.
- Study details: Participants may receive a combination of corticosteroids and either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
- Study Timelines: The study will last approximately 5 years.
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