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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.

En un coup d'œil

Statut
Recrutement
Phase
PHASE3
Sponsor
Pfizer
Objectif d'inscription
318
Démarrer
20 May 2023
Achèvement estimé
29 Jul 2030

De quoi parle cette étude ?

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.

Points clés

  • 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.

Qui peut être éligible ?

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.

Cet étude pourrait-elle vous convenir ?

Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.

  1. Avez-vous 18 ans ou plus ?
  2. Do you have active dermatomyositis (DM) or polymyositis (PM)?
  3. Are you currently on a stable dose of certain anti-inflammatory or immune-calming medicines?
  4. Do you have any other serious health conditions like recent cancer, severe infections, or major heart/brain problems?
Répondez à chaque question pour voir votre résultat.

En quoi consiste la participation ?

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.

Risques et avantages potentiels

Taking part in a study like this might offer potential benefits, such as receiving a new medicine that could help your condition or getting extra medical attention. However, there are also potential risks, as dazukibart is an experimental medicine, and we don't yet know all of its side effects. You might experience discomfort from injections or other procedures, or the medicine might not help your condition. It's important to remember that you can stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (138)

  • Arizona Arthritis & Rheumatology Research, PLLC
    Code postal vérifié
    Glendale, United States· Recrutement
  • Neuromuscular Research Center
    Code postal vérifié
    Phoenix, États-Unis· Recrutement
  • Mayo Clinic Hospital
    Code postal vérifié
    Phoenix, États-Unis· Recrutement
  • Mayo Clinic in Arizona - Scottsdale
    Code postal vérifié
    Scottsdale, États-Unis· Recrutement
  • 200 UCLA Medical Plaza
    Code postal vérifié
    Los Angeles, États-Unis· Recrutement
  • UCLA Clinical & Translational Research Center (CTRC)
    Code postal vérifié
    Los Angeles, États-Unis· Recrutement
  • UCLA
    Code postal vérifié
    Los Angeles, États-Unis· Recrutement
  • Center for Clinical Research - Chapman Pavilion
    Code postal vérifié
    Orange, United States· Actif, mais pas en recrutement
  • UCI Douglas Hospital
    Code postal vérifié
    Orange, United States· Actif, mais pas en recrutement
  • UCI Health Center for Innovative Health Therapies
    Code postal vérifié
    Orange, United States· Actif, mais pas en recrutement
  • University of California - Irvine
    Code postal vérifié
    Orange, United States· Actif, mais pas en recrutement
  • Samir Macwan, M.D., Inc.
    Code postal vérifié
    Rancho Mirage, United States· Recrutement

Questions fréquentes

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).

Qu'est-ce qu'un 'placebo' ?

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.

Comment le médicament sera-t-il administré ?

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.

Puis-je quitter l'étude si je change d'avis ?

Yes, you can leave the study at any time you wish, without giving a reason.

Comment en savoir plus

Centre d'appel Pfizer CT.gov

Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.

Intéressé à participer ?

Inscrivez votre intérêt

Partagez vos coordonnées et l'équipe de recherche pour "A Study to Understand How the Study Medicine (PF-06823859) W… vous contactera si vous êtes éligible. Consultez toujours votre médecin avant d'accepter de participer.

Discussion

Discussion communautaire

Propulsé par notre forum à community.patient.info. Veuillez être respectueux — ceci n'est pas un avis médical.