A clinical trial for people with active dermatomyositis or polymyositis.
We are studying a potential treatment to see if it can safely and effectively improve muscle symptoms in people with dermatomyositis or polymyositis.
The study medicine is thought to work by blocking an immune system protein called interferon β (IFNβ), which is found in higher levels in people with dermatomyositis and polymyositis and could drive the progression of these diseases by causing inflammation in the skin and muscles.
Participants in this clinical trial will receive care from a team of dedicated healthcare professionals for approximately 1 year.
Who may participate
Participating in a clinical trial is an important and personal decision. Thank you for taking the time to consider the My(O)Path trial as an option that may be right for you.
This clinical trial may be an option for people 18 years or older diagnosed with active dermatomyositis or polymyositis.
Everyone’s skin is different and many factors, including genetics, race, ethnicity, and sex, can impact how people respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds.
The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.
Condition
Active dermatomyositis or polymyositis
Age
18+ years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If you are a good fit for the trial, you will be assigned by chance to receive the study medicine or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
In this trial, you have a greater chance (2 in 3) of receiving the study medicine than the placebo (1 in 3). You will be asked to visit the trial clinic once every 4 weeks for 1 year.
You will receive the study medicine or placebo through a tube inserted in your arm known as an intravenous (IV) infusion. Each infusion will last approximately an hour.
You will be allowed to continue with certain background treatment for dermatomyositis or polymyositis. If you are being treated with corticosteroids, your study doctor may start lowering the dose of corticosteroids during your time in the trial.
Length of study treatment
12 months
Number of study visits
About 15 study visits
Long-term follow up
Option to receive the study medicine treatment and follow-up in the open-label extension study
Frequently asked questions
The study medicine is thought to work by blocking an immune system protein called interferon β (IFNβ). IFNβ is found in higher levels in people with dermatomyositis and polymyositis and is thought to drive these diseases.
There are some risks associated with taking part in this study. Taking the study treatment (study medicine or placebo) could make your condition worsen, get better, or stay the same.
Side effects of the study medicine may range from mild to serious. A full description of the risks of taking part in this study are given in the informed consent document, which you will be provided with before agreeing to take part in the study.
Your health will be monitored throughout the study. If your health gets worse, a decision will be made between you, the study doctor and the study team about whether you should continue to participate in the study. Your health will be prioritized.
A placebo does not have any medicine in it but looks just like the medicine being studied.
Neither you or the study team will know whether you are receiving the study medicine or the placebo.
You may not receive any direct benefit from taking part in this study. However, by taking part you are helping contribute to research that may help other people with active idiopathic inflammatory myopathies in the future.
Yes. Taking part in this study is completely voluntary. You can decide to end your participation at any point during the study and this will not affect your regular medical care.
Your health information and any data that could be used to identify you (such as immigration status) will be kept private and safe. Only information that relates to the study will be collected, and only your study team, study doctor, and organizations that oversee the study will be able to access it. Your personal information won’t be shared with third parties such as the government or advertisers.
