The VALOR Study is testing an investigational medicine called brepocitinib. Researchers want to see if it can safely reduce the symptoms of dermatomyositis in adults 18 to 75 years old.
What is dermatomyositis?
Dermatomyositis is a rare disease in which the immune system mistakenly attacks the skin and muscles. This causes muscle weakness, muscle pain, skin rash or redness, and fatigue. If not managed, dermatomyositis may eventually lead to muscle damage, difficulty swallowing, lung disease, and heart failure.
What is brepocitinib?
Brepocitinib is an investigational medication that is taken as a pill once a day. Brepocitinib is designed to block parts of the immune system involved in causing inflammation seen in dermatomyositis.
Who can participate in this study?
To be considered for the study, you must:
Be 18 to 75 years of age
Have a diagnosis of dermatomyositis
Currently taking or previously taken medication for dermatomyositis
Why should I participate?
If you are eligible to participate, you will receive study drug (brepocitinib or placebo) and all study-related care at no cost to you.
Your health will be closely monitored by a doctor who treats dermatomyositis.
You will also be a part of advancing the medical understanding of dermatomyositis, which may help other people with dermatomyositis in the future.
You will be in the study for up to 116 weeks (27 months). You will take the study drug given to you and visit the study site approximately every 4 to 12 weeks for tests and health checks.
up to 8 weeks, At least 1 visit
Permission: You will first need to give your consent, or permission, to join the study by reading the patient information sheet and signing the Informed Consent Form.
Check eligibility: The study doctor will then ask you about your symptoms of dermatomyositis, health history, and any medicines you take. You will also have a checkup and some tests to make sure the study is right for you.
Blinded Treatment Period
52 weeks, 11 visits
If eligible, you will be placed by chance (like flipping a coin) into a study treatment group. Neither you nor the study team will know which group you are in. This helps to keep the study fair.
This study is testing 2 different doses of brepocitinib. Your chance of receiving brepocitinib is twice as much as receiving placebo.
The placebo tablets look like brepocitinib but contain no active medicine. This gives the researchers something to compare brepocitinib to in order to measure its effects.
Open-Label Extension Period
52 weeks, 5 visits
If eligible and you choose to continue into the extension period, you will take brepocitinib once daily for 52 weeks.
4 weeks, 1 visit
You may have one last visit for tests 4 weeks after your final dose of study drug.
How do I take the study drug?
Take 3 tablets by mouth every morning after breakfast (you can take the tablets with or without food). While taking the study medicine, you will also continue all other therapies such as physical therapy, weight management and/or exercise routine as directed by your doctor.
What types of tests and health checks will I have at study visits?
Some of the tests and health checks you will have include:
Muscle testing and disease categorization
Surveys and questionnaires
Photos of your skin*
Lung function test*
*Not all tests may be required for each person in the study. The study doctor will let you know if you need these tests.
You will not have all tests at each study visit. Your study doctor will let you know which tests you will need.
You will be monitored continuously throughout the study for any changes in health or potential side effects.
Have more questions?
Answers to your questions about the VALOR Study can be found in the Frequently Asked Questions page.