Rise Above Dermatomyositis 
with VALOR

The VALOR Study is a clinical study for adults (from 18 to 74 years old) with dermatomyositis who are not finding symptom relief with current treatment.

What is the VALOR Study testing?

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 74 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 the part of the immune system involved in causing the inflammation seen in dermatomyositis.

Who can participate in this study?

To be considered for the study, you must:
Be 18 to 74 years of age
Have a diagnosis of dermatomyositis
Be taking a consistent dose of medication for your dermatomyositis
Have received a COVID-19 vaccine

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 specializes in dermatomyositis.
You will also be a part of advancing the medical understanding of dermatomyositis, which may help other people with dermatomyositis in the future.
Check Eligibility

What happens during the study?

You will be in the study for up to 64 weeks (15 months). You will take the study drug given to you and visit the study site approximately every 4 to 6 weeks for tests and health checks.

Screening

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.

Study 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.

Follow-Up Period

4 weeks, 1 visit

You may have one last visit for tests 4 weeks after your final dose of study drug. If you are eligible to participate in the planned extension study, and agree to participate, you will not be required to complete the follow-up period.

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.
Frequently Asked Questions

Find a Study Site Near You

Below is a list of centers participating in the study.
See if you are Eligible

Florida

University of Florida Health - Springhill
Gainesville, FL
HMD Research LLC
Orlando, FL
Integral Rheumatology & Immunology Specialists (IRIS)
Plantation, FL

Where do I go if I'm interested in joining the study?

Click here to see if you may be eligible for this study and speak with your doctor for more information.

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