Frequently 
Asked Questions

General Study Questions

What are the benefits of being in the clinical study?
You may or may not directly benefit from being in the clinical study. However, the information collected during the VALOR Study may help doctors learn more about the study drug and dermatomyositis, which may help others with dermatomyositis the future.
Will it cost me anything to be in the study?
It will not cost you anything to participate in the study. You may be able to get reimbursed for your travel costs to and from the study site. Speak to a member of the study team for more information.
Who is sponsoring the study?
The biotechnology company Priovant Therapeutics is sponsoring the VALOR Study. Priovant Therapeutics is committed to developing targeted therapies for people living with severe autoimmune disease.
Do I have to stay in the study if I decide to join?
No, being in the study is completely voluntary. If you decide to join and then change your mind, you can leave the study at any time.

Study Setup Questions

How long will I be in the study?
You will be in the study for up to 64 weeks, or 15 months.
How many times will I have to go to the study site?
You will visit the study site for tests and health checks about 13 times during the study, approximately every 4 to 6 weeks. Your study doctor may ask you to come in for extra visits if needed to protect your well-being.

Study Treatment Questions

What treatment will I receive during the study?
If you qualify for the study, you will be placed by chance in a treatment group to receive one of two doses of the study drug or placebo.
What does investigational medicine mean?
Investigational medicine means that it has not been approved by country-specific regulatory health authorities to be used for dermatomyositis and its use is being allowed for research purposes only.
What is placebo?
The placebo looks like the study drug but contains no active medicine. This gives researchers something to compare the study drug to in order to better understand its effects.
Do I need to stop taking my current medications?
You will continue to receive your current medication in addition to study drug or placebo. The study doctor will advise you on which medication(s) you will continue to take.
How are the treatment groups assigned?
A computer is used to assign study participants to study treatment groups by chance, like flipping a coin. This is called randomization.
Are there any side effects from the study medicine?
Like all medicines, there is a chance for side effects, which are unwanted and unintended effects from a medicine. Your health will be closely monitored during the entire study. It is very important to tell the study doctor if you notice any changes in your health or if anything is bothering you.
Where can I go for support for living with dermatomyositis?
For more information about dermatomyositis, including access to support and resources, please visit:
- The Myositis Association (myositis.org)
- Myositis Support and Understanding Association (understandingmyositis.org).
- Autoimmune Association (autoimmune.org)

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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