RecruitingPHASE3INTERVENTIONAL

Baricitinib in Patients With Relapsing or naïve Dermatomyositis

This research is looking into a new treatment called baricitinib for adults aged 18-64 who have dermatomyositis. Dermatomyositis is a rare condition that affects muscles and skin, often requiring strong steroid medicines which can have unwanted side effects. The study wants to find out if baricitinib can help improve the condition and allow patients to use less steroid medication than with current treatments. Patients will either receive baricitinib or a dummy pill (placebo), both in addition to their usual care. This is a crucial step in finding potentially better and safer ways to manage dermatomyositis, focusing on reducing symptoms and steroid dependency.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

31 Aug 2022

Estimated completion

28 Feb 2028

Dermatomyositis

What is this study about?

Dermatomyositis (DM) is a rare condition that causes muscle weakness and skin rashes. It can significantly impact a person's daily life and, in some cases, lead to serious health problems. Currently, a main treatment for DM involves high doses of steroid medications. While these steroids can be effective, they often come with unwanted side effects, like heart problems or damage to muscles and skin. Also, reducing the steroid dose can sometimes lead to a return of symptoms. Other medications are used too, but they might not work for everyone and can take a long time to show effects.

This study, called BIRD, is investigating a new medicine named baricitinib. Researchers believe baricitinib might help reduce the inflammation and damage seen in DM because it targets a specific pathway in the body involved in the condition. The goal is to see if baricitinib can improve DM symptoms and, importantly, help patients reduce or even stop using steroid medications without their symptoms flaring up. This could offer a milder and more effective way to manage the condition.

This study is a Phase 3 clinical trial, which means it's a key stage in testing a new drug before it can be widely used. It's a 'double-blind, randomised, placebo-controlled' study. This means some patients will receive baricitinib, and others will receive a dummy pill (placebo), in addition to their usual care. Neither the patients nor their doctors will know who is getting which, to ensure fair results. The study aims to find out if baricitinib can lead to a significant improvement in DM symptoms without the need for steroids after 24 weeks.

Key takeaways

This study is testing a new drug for dermatomyositis called baricitinib.
It aims to reduce symptoms and the need for steroids in adult patients.
Participants will receive either baricitinib or a dummy pill alongside their usual care.
The study lasts 24 weeks and involves regular hospital visits and health checks.
It's a 'double-blind' study, meaning neither you nor your doctors will know which treatment you receive.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult with dermatomyositis, aged between 18 and 64 years old. Your dermatomyositis must be active, meaning you are currently experiencing symptoms like muscle weakness or significant skin rash, or have certain abnormal test results. If you are already taking steroids, your dose should be stable and not too high for at least four weeks before joining. If you’re on other immunosuppressant medicines, that dose should also be stable for at least three months.

However, there are also some reasons why you might not be able to join. For example, if you have very serious complications from your dermatomyositis, such as severe difficulty swallowing or lung problems that make it very hard to breathe, you wouldn't be eligible. Also, if you have a history of blood clots, heart attacks, or strokes, or if you are a current or past long-term smoker, you would not be able to participate.

Finally, if you are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding, this study would not be suitable for you.

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 with dermatomyositis, aged 18 to 64?
Do you currently have active dermatomyositis symptoms?
If you take steroids, has your dose been stable and not too high for at least 4 weeks?
Do you have stable doses of other immune-suppressing medicines you might be taking for at least 3 months?
Are you not pregnant, breastfeeding, or planning to become pregnant/breastfeed?
Do you not have very severe complications from dermatomyositis or certain heart/lung issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of two groups: either you'll receive baricitinib, or you'll receive a dummy pill (placebo), in addition to your current dermatomyositis treatment and a plan to reduce your steroid dosage quickly. Neither you nor your study doctor will know which group you are in. You'll have regular visits at the hospital, likely at departments specialising in dermatology, rheumatology, or internal medicine in France. These visits will involve various assessments, including checks on your muscle strength, skin condition, and blood tests to monitor your progress and make sure the treatment is safe for you. The main part of the study where the treatment is given will last 24 weeks, during which your doctors will aim to significantly reduce your steroid use. After this, there will be further follow-up appointments.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from a new treatment that could improve your dermatomyositis and reduce your reliance on steroids, potentially leading to fewer side effects from current medications. However, there's also a chance you could receive the dummy pill, meaning you wouldn’t get the active study drug. There might be unknown side effects from baricitinib, or known side effects that could impact you. Your health will be closely monitored, and you will receive careful medical attention throughout the study. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Pitie-Salpêtrière hospital APHP
Verified postcode
Paris, France· Recruiting

Common questions

What is dermatomyositis?

Dermatomyositis is a rare condition that causes muscle weakness and skin rashes. It's an autoimmune disease, meaning your body's immune system mistakenly attacks its own tissues.

What is baricitinib?

Baricitinib is a medicine that works by blocking certain signals in your immune system. Researchers hope it can help reduce the inflammation and symptoms in dermatomyositis.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real drug's effects accurately.

Will I have to stop my current medicines?

No, this study adds baricitinib or placebo to your existing usual care. You'll likely continue your regular treatments, though there's a plan to reduce your steroid dose quickly.

How long will the study last for me?

The main treatment period is 24 weeks, where you'll receive either baricitinib or placebo. There will then be follow-up appointments after this period.

How to find out more

YVES ALLENBACH, MD, PhD

yves.allenbach@aphp.fr 00 33 1 42 16 10 68 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.