Study on the Effectiveness of Dazukibart in Adults with Active Dermatomyositis or Polymyositis

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What is this study about?

This clinical trial is focused on studying a group of diseases known as idiopathic inflammatory myopathies, which include specific conditions like dermatomyositis and polymyositis. These are conditions that cause muscle inflammation and weakness. The study aims to evaluate the effectiveness and safety of a treatment called PF-06823859, also known as Dazukibart, which is a type of protein-based medication designed to target and neutralize certain proteins involved in inflammation. Participants in the study may receive either the actual medication or a placebo, which is a substance with no active ingredients, to compare the effects.

The study will also involve other medications that are commonly used to manage these conditions, such as methotrexate, azathioprine, and various glucocorticosteroids like methylprednisolone, dexamethasone, and prednisone. These medications help reduce inflammation and suppress the immune system. The trial will last for about a year, during which participants will receive regular treatments and assessments to monitor their muscle symptoms and overall health.

The purpose of this study is to determine if PF-06823859 can effectively reduce muscle symptoms in adults with active dermatomyositis or polymyositis. Participants will be randomly assigned to different groups to receive either the study medication or a placebo, and their progress will be closely monitored by healthcare professionals. The study will help researchers understand the potential benefits and risks of this new treatment option for people living with these challenging muscle conditions.

Who Can Join the Study?

You must be an adult, which means you are at least 18 years old or the legal age of adulthood in your area.
You must have a confirmed diagnosis of Idiopathic Inflammatory Myopathies (IIM), which is a group of rare diseases that cause muscle inflammation.
Specifically, you must have Dermatomyositis (DM), a condition that affects both the skin and muscles, or Polymyositis (PM), a condition that primarily affects the muscles.
If you have Dermatomyositis, you must show specific skin signs, such as Gottron’s papules (red bumps on the knuckles), Gottron’s sign (redness on the joints), or a Heliotrope eruption (a purple-colored rash on the eyelids).
If you have Polymyositis, you must show muscle weakness in specific areas, such as the upper or lower arms and legs, and you must not have the specific skin rashes seen in Dermatomyositis.
Your condition must be active, meaning your symptoms are currently present and measurable.
Active disease is confirmed if your muscle strength, measured by a test called MMT-8, is below a certain level, or if you have high levels of muscle enzymes (proteins in the blood that indicate muscle damage).
Your active disease may also be confirmed through an MRI (a medical imaging scan) that shows edema (swelling or fluid buildup) in the muscles, or through a muscle biopsy (a small sample of muscle tissue removed for testing) that shows signs of inflammation.
You must be taking a stable dose of your current regular medications, which means your dosage has not changed recently.
Your regular medications must include either an oral corticosteroid (a type of steroid medicine used to reduce inflammation) or an immunosuppressant (a medicine that lowers your immune system activity), or both.
Your diagnosis must not be caused by other conditions like inclusion body myositis (IBM) or immune-mediated necrotizing myositis (IMNM), which are different types of muscle diseases.

Who Cannot Join the Study?

Having myositis (muscle inflammation) that is not caused by idiopathic inflammatory myopathies (a group of diseases where the body’s immune system attacks the muscles for unknown reasons).
Having a diagnosis of inclusion body myositis (a specific type of muscle disease that usually affects older adults).
Having immune-mediated necrotizing myopathy (a severe muscle disease where muscle cells are destroyed), specifically if medical records show the presence of certain proteins called anti-SRP or anti-HMGCR antibodies.
Having myositis that has caused end-stage organ involvement (this means a vital organ like the heart or lungs has reached a very advanced and damaged state) at the start of the study.
Being unable to walk or being limited to using a wheelchair.
Needing to use oxygen supplementation (extra oxygen delivered through a device) at the time of the initial medical check.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland
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Hopitaux Universitaires Pitie Salpetriere	Paris	France
Ospedale San Raffaele S.r.l.	Milan	Italy
Karolinska University Hospital	Solna	Sweden
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
Hospital Edouard Herriot	Lyon	France
Hospital Universitario Infanta Leonor	Madrid	Spain
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
University Of Debrecen	Debrecen	Hungary
Dkc Fokus-5 Lzip OOD	Sofia	Bulgaria
INTER CLINIC Piotr Adrian Klimiuk	Bialystok	Poland
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Ludwig Maximilian University Of Munich	Munich	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
University Of Pecs	Pecs	Hungary
Hospital Universitario De Canarias	La Laguna	Spain
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Malopolskie Centrum Kliniczne	Cracow	Poland
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.	Bialystok	Poland
Narodny Ustav Reumatickych Chorob	Piestany	Slovakia
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Poznan	Poland
Ctenzq Hvagrpimskn Ufhlbmwyirjfp Rdezu	Reims	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.11.2023
Bulgaria	Recruiting	15.11.2023
France	Recruiting	15.11.2023
Germany	Recruiting	15.11.2023
Hungary	Recruiting	15.11.2023
Italy	Recruiting	15.11.2023
Poland	Recruiting	15.11.2023
Slovakia	Recruiting	15.11.2023
Spain	Recruiting	15.11.2023
Sweden	Recruiting	15.11.2023

Trial locations

Investigated drugs:

Dazukibart is a medication being tested to see if it can help reduce muscle symptoms in adults with active inflammatory muscle diseases.

PF-06823859 is a specialized therapy designed to target and block certain proteins in the body that are involved in inflammation, which may help manage the condition.

Investigated diseases:

Dermatomyositis – This is an inflammatory disease that primarily affects the skin and muscles. It often presents with characteristic skin rashes and progressive muscle weakness. The condition involves the immune system attacking healthy tissues, leading to inflammation. Over time, the muscle weakness can spread to different parts of the body.

Polymyositis – This is an inflammatory disease characterized by muscle weakness. It primarily affects the proximal muscles, which are those closest to the center of the body, such as the hips and shoulders. The disease progresses as the inflammation causes the muscles to become weaker and more difficult to use. Unlike some related conditions, it typically does not involve a prominent skin rash.

Trial ID:

2022-502739-20-00

Protocol code:

C0251006

NCT ID:

NCT05895786

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Dazukibart in Adults with Active Dermatomyositis or Polymyositis

What is this study about?

Who Can Join the Study?

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