A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
This study is investigating a new drug called brepocitinib for adults aged 18 to 75 who have dermatomyositis. It's a phase 3 trial, which means the drug has already undergone earlier testing. Researchers will compare two different doses of brepocitinib with a placebo (a dummy pill) to see how well they improve symptoms, particularly using a scoring system called the Total Improvement Score (TIS). The main part of the study lasts 52 weeks, during which participants won't know if they're receiving the drug or the placebo. After this, all participants will have the option to continue receiving brepocitinib for another 52 weeks in an open-label extension phase, meaning everyone will know they are getting the active medication. The aim is to find out if brepocitinib is a safe and effective treatment for dermatomyositis.
At a glance
What is this study about?
This study is focused on a health condition called dermatomyositis (DM). This is a rare disease that causes muscle weakness and a skin rash. It happens when the body's immune system, which normally fights off infections, mistakenly attacks healthy tissues.
The researchers want to test a new medication called brepocitinib to see if it can help adults with dermatomyositis. This medication works by blocking certain signals in the body (called TYK2/JAK1 inhibitors) that are involved in the immune response. By blocking these signals, the hope is to calm down the overactive immune system and reduce the symptoms of dermatomyositis.
This is a 'Phase 3' study, which means it's one of the final stages of testing a new medicine before it might become widely available. The main goal is to find out if brepocitinib is better than a dummy pill (placebo) at improving symptoms and if it's safe to use. They will look at how much participants' symptoms improve over time using a special scoring system. After the first year, participants can choose to continue in the study for another year, and at that point, everyone will receive brepocitinib.
Key takeaways
- New drug (brepocitinib) being tested for dermatomyositis.
- Compares brepocitinib to a dummy pill (placebo) for one year.
- Participants will have regular medical check-ups and tests.
- Optional second year where everyone receives brepocitinib.
- Aims to find out if the drug is safe and effective.
- You can stop participating at any time.
Who may be eligible?
To join this study, you would generally need to be an adult between 18 and 75 years old and have been diagnosed with dermatomyositis using specific medical guidelines. It's important that your dermatomyositis is currently active, meaning you have noticeable muscle and/or skin symptoms. You might also be allowed to join if you're already taking certain common medications for dermatomyositis, such as steroids, hydroxychloroquine, or another anti-inflammatory drug, or if you've used them in the past. Your weight and body mass index (BMI) would also need to be within a certain range.
However, there are reasons why you might not be able to join. For instance, if your dermatomyositis is very severe and has caused irreversible damage to your organs or muscles, you wouldn't be eligible. The study also cannot include individuals who have certain types of cancer or a history of cancer in the last five years (with a few exceptions for very common or easily treated skin or breast cancers), or if your dermatomyositis is linked to cancer. Other reasons for not being able to join include having a high risk of blood clots or heart problems, a high risk of shingles, or an active infection at the time of screening.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult between 18 and 75 years old?
- Do you have a diagnosis of dermatomyositis?
- Do you currently have active muscle or skin symptoms from your dermatomyositis?
- Are you within a certain weight and body mass index (BMI) range?
- Do you have certain serious health conditions like recent cancer or severe organ damage?
What does participation involve?
If you decide to take part, you would first go through a screening process to make sure you meet all the study requirements. Once enrolled, you would receive either brepocitinib or a placebo (a dummy pill) for 52 weeks. Neither you nor your study doctor would know which one you are receiving during this time. You'll have regular visits to the clinic for assessments, which will include physical examinations, blood tests, and discussions about your symptoms to track your progress and safety. After the first 52 weeks, you'll have the option to continue for another 52 weeks in an 'open-label' phase, where everyone receives brepocitinib and knows they are getting the active medication. The total duration of the study, if you choose to participate in both phases, would be around two years.
Potential risks and benefits
Locations (109)
- Clinical Trial SiteVerified postcodePhoenix, United States
- Clinical Trial SiteVerified postcodeScottsdale, United States
- Clinical Trial SiteVerified postcodeScottsdale, United States
- Clinical Trial SiteVerified postcodeIrvine, United States
- Clinical Trial SiteVerified postcodeLos Angeles, United States
- Clinical Trial SiteVerified postcodeSan Francisco, United States
- Clinical Trial SiteVerified postcodeAurora, United States
- Clinical Trial SiteVerified postcodeDenver, United States
- Clinical Trial SiteVerified postcodeBoynton Beach, United States
- Clinical Trial SiteVerified postcodeGainesville, United States
- Clinical Trial SiteVerified postcodeJacksonville, United States
- Clinical Trial SiteVerified postcodePlantation, United States
Common questions
What is dermatomyositis?
Dermatomyositis is a rare condition where your body's immune system mistakenly attacks healthy tissues, leading to muscle weakness and a skin rash.
What is brepocitinib?
Brepocitinib is a new medication being tested. It aims to calm down the overactive immune system in people with dermatomyositis.
What does 'placebo-controlled, double-blind' mean?
It means some participants will get the actual medicine, and others will get a dummy pill (placebo). Neither you nor your study doctor will know which you are receiving during the first year, to ensure fair results.
How long does the study last?
The main part of the study lasts 52 weeks (about one year). You might then have the option to continue for another 52 weeks, making the total duration about two years.
Can I leave the study early?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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