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ReclutamentoFASE3INTERVENTISTICO

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.

A colpo d'occhio

Stato
Reclutamento
Fase
FASE3
Sponsor
Pfizer
Obiettivo di iscrizione
318
Inizio
20 May 2023
Completamento stimato
29 Jul 2030

Di cosa tratta questo studio?

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.

Punti chiave

  • 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.

Chi può essere idoneo?

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.

Questo studio potrebbe fare al caso tuo?

Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.

  1. Hai 18 anni o più?
  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?
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

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.

Rischi e benefici potenziali

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
    Codice postale verificato
    Glendale, Stati Uniti· Reclutamento
  • Neuromuscular Research Center
    Codice postale verificato
    Phoenix, Stati Uniti· Reclutamento
  • Mayo Clinic Hospital
    Codice postale verificato
    Phoenix, Stati Uniti· Reclutamento
  • Mayo Clinic in Arizona - Scottsdale
    Codice postale verificato
    Scottsdale, Stati Uniti· Reclutamento
  • 200 UCLA Medical Plaza
    Codice postale verificato
    Los Angeles, Stati Uniti· Reclutamento
  • UCLA Clinical & Translational Research Center (CTRC)
    Codice postale verificato
    Los Angeles, Stati Uniti· Reclutamento
  • UCLA
    Codice postale verificato
    Los Angeles, Stati Uniti· Reclutamento
  • Center for Clinical Research - Chapman Pavilion
    Codice postale verificato
    Orange, Stati Uniti· Attivo ma non reclutante
  • UCI Douglas Hospital
    Codice postale verificato
    Orange, Stati Uniti· Attivo ma non reclutante
  • UCI Health Center for Innovative Health Therapies
    Codice postale verificato
    Orange, Stati Uniti· Attivo ma non reclutante
  • University of California - Irvine
    Codice postale verificato
    Orange, Stati Uniti· Attivo ma non reclutante
  • Samir Macwan, M.D., Inc.
    Codice postale verificato
    Rancho Mirage, United States· Reclutamento

Domande comuni

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).

What is a '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.

Come verrà somministrato il medicinale?

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.

Posso abbandonare lo studio se cambio idea?

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

Come saperne di più

Pfizer CT.gov Call Center

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