The VALOR Study is a clinical study for adults (from 18 to 75 years old) with dermatomyositis who are not finding symptom relief with current treatment.
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
What happens during the study?
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.
Screening Period
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.
Brepocitinib
This study is testing 2 different doses of brepocitinib. Your chance of receiving brepocitinib is twice as much as receiving placebo.
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.
Follow-Up Period
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:
Physical exam
Vital signs
Medicine review
Heart activity
Muscle testing and disease categorization
Surveys and questionnaires
Blood tests
Urine tests
Photos of your skin*
Chest X-ray*
Imaging scan*
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.
This site uses Cookies. To learn more, please review our Privacy Policy.
Manage consent
Privacy Overview
This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie
Duration
Description
cookielawinfo-checkbox-analytics
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional
11 months
The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance
11 months
This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy
11 months
The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.