A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
This study is investigating a new medication called efgartigimod PH20 SC for adults living with certain types of active idiopathic inflammatory myopathy (IIM). IIM is a condition that causes muscle inflammation and weakness. The study aims to find out if this new drug is effective and safe compared to a placebo, which is a dummy treatment with no active medicine. Researchers will be looking at how participants respond to the treatment, specifically checking for improvements in their overall condition. The trial includes specific types of IIM, such as dermatomyositis, immune-mediated necrotizing myopathy, and certain forms of polymyositis. If you have one of these conditions and meet certain criteria, you might be able to take part. More information is available on the study website.
Överblick
Vad handlar denna studie om?
This study is about a new treatment for a group of conditions known as Idiopathic Inflammatory Myopathies (IIM). These conditions cause your immune system to mistakenly attack your muscles, leading to inflammation, weakness, and sometimes skin problems. This study is specifically looking at adults who have active forms of conditions like dermatomyositis, polymyositis (including antisynthetase syndrome), and immune-mediated necrotizing myopathy.
The main goal is to see if a new drug, called efgartigimod PH20 SC, can help improve symptoms and overall well-being compared to a placebo. A placebo looks like the real treatment but contains no active medication. This comparison helps researchers understand the true effects of the new drug. By carefully studying how people respond, doctors hope to find better ways to manage these challenging conditions and improve the lives of those affected.
Finding new, effective treatments for IIM is really important. Current treatments can have side effects and don't work for everyone. This study could lead to a new option that helps more people feel better, regain muscle strength, and reduce inflammation, ultimately improving their quality of life.
Viktiga punkter
- A new drug for muscle inflammation (IIM) is being tested.
- The study compares the new drug to a dummy treatment (placebo).
- It's for adults with active forms of dermatomyositis, polymyositis, or IMNM.
- The goal is to find out if the drug improves muscle strength and overall well-being.
- Deltagande innebär regelbundna klinikbesök och hälsokontroller.
Vem kan vara berättigad?
To join this study, you need to be an adult (18 years or older) with a confirmed diagnosis of idiopathic inflammatory myopathy (IIM). This includes specific types like dermatomyositis, polymyositis (including antisynthetase syndrome), or immune-mediated necrotizing myopathy.
It's also important that your IIM is currently active. This might mean you have certain abnormal blood test results, recent signs of muscle disease on an electromyogram or MRI scan, an active skin rash from dermatomyositis, or changes seen in a recent muscle biopsy. You should also be experiencing muscle weakness and be on a stable background treatment for your IIM.
There are also some reasons why you might not be able to join. For example, if you have an active infection, have recently tested positive for COVID-19, or have another serious autoimmune disease that might complicate the study. You also cannot have a history of cancer unless it's completely cured.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Är du 18 år eller äldre?
- Do you have a diagnosis of dermatomyositis, immune-mediated necrotizing myopathy, or polymyositis (including antisynthetase syndrome)?
- Is your muscle condition currently active (e.g., recent abnormal blood tests, muscle weakness)?
- Are you currently receiving a stable treatment for your muscle condition?
- Do you not have an active infection or certain other serious health conditions?
Vad innebär deltagande?
If you decide to take part in this study, you'll be assigned to either receive the new drug, efgartigimod PH20 SC, or a placebo (a dummy treatment). You won't know which one you're getting, and neither will your study doctor, to ensure the results are unbiased. The new drug is given as an injection under the skin.
Your participation will involve regular visits to the study clinic. During these visits, you'll have various assessments to check your progress and safety. These might include physical examinations, blood tests, and questionnaires about your symptoms and how you're feeling. The study will carefully monitor how your body reacts to the treatment and if your IIM symptoms are improving. The total duration of the study will be explained in detail by the study team, along with specific timelines for follow-up appointments.
Potentiella risker och fördelar
Locations (202)
- Neuromuscular Research CenterVerifierat postnummerPhoenix, USA
- HonorHealth Neurology - Bob Bove Neuroscience Institute - NeurologyVerifierat postnummerScottsdale, USA
- Attune Health Research, IncVerifierat postnummerBeverly Hills, USA
- University of Southern California Norris Comprehensive Cancer CenterVerifierat postnummerLos Angeles, USA
- Profound Research LLC - OceansideVerifierat postnummerOceanside, United States
- University of California, IrvineVerifierat postnummerOrange, USA
- Eisenhower Medical CenterVerifierat postnummerRancho Mirage, USA
- Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of MedicineVerifierat postnummerRedwood City, USA
- California Pacific Medical Center - Sutter HealthVerifierat postnummerSan Francisco, USA
- Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)Verifierat postnummerSan Francisco, USA
- Denver Arthritis ClinicVerifierat postnummerDenver, USA
- Yale Cancer Center-Yale University School Of MedicineVerifierat postnummerNew Haven, USA
Vanliga frågor
What is Idiopathic Inflammatory Myopathy (IIM)?
IIM is a group of conditions where your body's immune system mistakenly attacks your muscles, causing inflammation and weakness.
What is the new drug being tested?
The new drug is called efgartigimod PH20 SC. It's hoped to help reduce muscle inflammation and weakness.
Vad är en placebo?
A placebo is a 'dummy' treatment that looks like the actual medicine but contains no active drug. It helps researchers compare the real drug's effects.
Kommer jag att veta om jag får läkemedlet eller placebon?
No, you won't know if you're receiving the active drug or the placebo. This helps ensure the study results are fair and accurate.
How will the study measure if the treatment works?
The study will measure changes in your overall condition, including muscle strength and how you feel, using something called a 'Total Improvement Score'.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Diskussion
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