A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
This research study is looking into a new medicine, dazukibart, for people with muscle conditions called dermatomyositis (DM) and polymyositis (PM). These conditions cause muscles to become weak and can also cause a skin rash in DM. The study aims to understand how this new medicine works, if it can help improve symptoms, and if it is safe. Participants in the study will either receive the new medicine or a dummy medicine (placebo) through an IV drip once a month for about a year. By comparing these two groups, researchers hope to learn if dazukibart could be a helpful treatment option.
במבט חטוף
על מה המחקר הזה?
This study is investigating a new medicine called dazukibart for conditions known as idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM). These are rare conditions where your body's immune system mistakenly attacks your muscles, making them weak. This can make everyday activities like walking, climbing stairs, or getting up from a chair difficult. People with dermatomyositis also often get a distinctive skin rash.
The main goal of this study is to find out if dazukibart can help improve the muscle weakness and other symptoms of DM and PM, and importantly, if it is safe for people to use. To do this, researchers will give some participants the new medicine and others a 'placebo', which looks exactly like the study medicine but contains no active drug. This allows them to clearly see if any changes are due to the new medicine itself.
Understanding how dazukibart works could potentially lead to a new treatment option for people living with these challenging conditions. Your participation could help advance medical knowledge and potentially benefit others in the future.
נקודות עיקריות
- This study evaluates a new medicine (dazukibart) for dermatomyositis (DM) and polymyositis (PM).
- It aims to understand if dazukibart is safe and effective for muscle weakness.
- Participants will receive either dazukibart or a placebo via IV drip once a month.
- The study lasts about 13 months and involves regular clinic visits.
- Participation includes health checks and close monitoring by the study team.
מי עשוי להיות זכאי?
To be considered for this study, you need to be an adult, aged 18 or over, and have been diagnosed with active dermatomyositis (DM) or polymyositis (PM). You should also be taking a steady dose of a common anti-inflammatory medicine (like a corticosteroid) or another type of medicine that calms your immune system, or both.
There are also some reasons why you might not be able to join. For example, if your muscle weakness is due to a different condition, or if you have certain other serious health issues like some cancers, severe infections, or other significant diseases that could make the study medicine unsafe for you. We also can't include people who have had certain organ transplants or serious heart or brain conditions recently.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בן 18 או יותר?
- Do you have active dermatomyositis (DM) or polymyositis (PM)?
- Are you currently on a stable dose of certain anti-inflammatory or immune-calming medicines?
- Do you have any other serious health conditions like recent cancer, severe infections, or major heart/brain problems?
מה כרוך בהשתתפות?
If you join this study, it will last for about 13 months. During this time, you will have 15 visits to the study centre. At these visits, you will receive either the study medicine (dazukibart) or a placebo (a dummy medicine with no active ingredients). Both will be given through a drip into your vein (an IV infusion), which takes about an hour, and this will happen every four weeks for 48 weeks.
Throughout the study, the research team will regularly check your health, symptoms, and how you are responding to the treatment. This will involve physical exams, blood tests, and asking questions about how you are feeling. All these checks are done to monitor your safety and see how the medicine is working.
סיכונים ותועלות פוטנציאליים
מיקומים (138)
- Arizona Arthritis & Rheumatology Research, PLLCמיקוד מאומתגלנדייל, ארצות הברית· גיוס
- Neuromuscular Research Centerמיקוד מאומתפניקס, ארצות הברית· גיוס
- בית חולים מאיו קליניקמיקוד מאומתפניקס, ארצות הברית· גיוס
- Mayo Clinic in Arizona - Scottsdaleמיקוד מאומתסקוטסדייל, ארצות הברית· גיוס
- 200 UCLA Medical Plazaמיקוד מאומתלוס אנג'לס, ארצות הברית· גיוס
- UCLA Clinical & Translational Research Center (CTRC)מיקוד מאומתלוס אנג'לס, ארצות הברית· גיוס
- UCLAמיקוד מאומתלוס אנג'לס, ארצות הברית· גיוס
- Center for Clinical Research - Chapman Pavilionמיקוד מאומתאורנג', ארצות הברית· פעיל אך לא מגייס
- UCI Douglas Hospitalמיקוד מאומתאורנג', ארצות הברית· פעיל אך לא מגייס
- UCI Health Center for Innovative Health Therapiesמיקוד מאומתאורנג', ארצות הברית· פעיל אך לא מגייס
- University of California - Irvineמיקוד מאומתאורנג', ארצות הברית· פעיל אך לא מגייס
- Samir Macwan, M.D., Inc.מיקוד מאומתRancho Mirage, United States· גיוס
שאלות נפוצות
What are dermatomyositis (DM) and polymyositis (PM)?
They are rare conditions where your immune system attacks your muscles, causing weakness and sometimes a skin rash (in DM).
מהו 'פלצבו'?
A placebo looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is effective.
כיצד יינתן התרופה?
The medicine or placebo will be given through a drip into a vein (an IV infusion) at the study centre.
How long will I take part in the study?
You will be in the study for about 13 months, with visits to the study centre every four weeks.
האם אני יכול לעזוב את המחקר אם אשנה את דעתי?
Yes, you can leave the study at any time you wish, without giving a reason.
כיצד לגלות עוד
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