Study on the Long-Term Safety of Dazukibart in Patients with Idiopathic Inflammatory Myopathies, Including Dermatomyositis and Polymyositis

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What is this study about?

This clinical trial is focused on studying the long-term safety and effects of a treatment called dazukibart in people with a group of muscle diseases known as idiopathic inflammatory myopathies. These diseases include specific types like dermatomyositis and polymyositis, which cause muscle inflammation and weakness. The study aims to understand how well the treatment is tolerated over time and its impact on these conditions.

Participants in this study will receive dazukibart, which is a type of medication known as a monoclonal antibody. This medication is designed to target and neutralize specific proteins in the body that may contribute to inflammation. The study will also involve other medications, including betamethasone, hydroxychloroquine, chloroquine phosphate, hydrocortisone, triamcinolone acetonide, methylprednisolone, mycophenolate mofetil, budesonide, dexamethasone, azathioprine, prednisolone, methotrexate, deflazacort, leflunomide, and prednisone. Some participants may receive a placebo instead of the active medication.

The study will last for up to 52 weeks, during which participants will be monitored for any side effects and changes in their condition. The goal is to gather information on the safety of dazukibart and its effectiveness in managing symptoms of idiopathic inflammatory myopathies. Participants will undergo regular check-ups and assessments to track their progress and any changes in their health status.

1 joining the study

Participation begins after completing a previous study. Eligibility requires completion of a 52-week treatment period in the prior study without early discontinuation.

2 treatment phase

The main objective is to evaluate the long-term safety of dazukibart in individuals with idiopathic inflammatory myopathies, including dermatomyositis (DM) and polymyositis (PM).

Participants will receive dazukibart as a solution for injection. The frequency and dosage will be determined by the study protocol.

3 monitoring and assessments

Regular assessments will be conducted to monitor safety and efficacy. This includes checking for any adverse events, changes in laboratory tests, and vital signs.

Specific evaluations will include changes in muscle strength, disease activity, and quality of life measures.

4 completion of study

The study is estimated to end on November 11, 2027. Participants will continue to be monitored until the study’s conclusion.

Who Can Join the Study?

Participants must have a condition called Idiopathic Inflammatory Myopathy, which includes types like dermatomyositis or polymyositis. These are conditions that cause muscle inflammation and weakness.
Participants should have completed the treatment period of a previous related study without stopping the treatment early. Specifically, if they were part of the C0251006 study, they must have completed the 52-week treatment period.
Both males and females are eligible to participate in the study.
The study is open to participants who are not considered part of a vulnerable population, meaning they are not in a group that might need special protection or care.

Who Cannot Join the Study?

Participants with any other serious health condition that could interfere with the study.
Individuals who have had a recent infection that required treatment with antibiotics.
People who have received any other investigational drug within the last 30 days.
Participants who have a history of allergic reactions to similar medications.
Individuals with a history of drug or alcohol abuse.
Women who are pregnant or breastfeeding.
Participants who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.	Bialystok	Poland
Malopolskie Centrum Kliniczne	Cracow	Poland
University Of Debrecen	Debrecen	Hungary
Dkc Fokus-5 Lzip OOD	Sofia	Bulgaria
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Poznan	Poland
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Acjhaht 1b Cly Sp	Do Not Edit	Sweden
Nyhdcxmq Ixcbopns Gkfppuikm Rxnwerfobwfs I Rxenoqtuumafs Ix Pebhw Ds Hoyx Mmdt Ewdvstqw Rnrvmth	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	25.04.2025
Hungary	Recruiting	25.04.2025
Italy	Not yet recruiting	25.04.2025
Poland	Recruiting	25.04.2025
Spain	Not yet recruiting	25.04.2025
Sweden	Not yet recruiting	25.04.2025

Trial locations

Investigated drugs:

Dazukibart is a medication being studied for its long-term safety, tolerability, and effectiveness in treating idiopathic inflammatory myopathies, which include conditions like dermatomyositis and polymyositis. These are diseases that cause muscle inflammation and weakness. The study aims to see how well patients tolerate the medication over an extended period and to monitor any side effects or improvements in their condition.

Idiopathic Inflammatory Myopathy – This is a group of rare diseases characterized by chronic muscle inflammation and weakness. It includes conditions such as dermatomyositis and polymyositis. Dermatomyositis often presents with a distinctive skin rash along with muscle weakness, while polymyositis primarily affects the muscles without a rash. The muscle weakness typically progresses over weeks to months, affecting the ability to perform daily activities. These conditions can also involve other organs, leading to symptoms beyond muscle weakness. The exact cause is unknown, but it is believed to involve an autoimmune response where the body’s immune system mistakenly attacks its own tissues.

Trial ID:

2024-514648-10-00

Protocol code:

C0251010

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Long-Term Safety of Dazukibart in Patients with Idiopathic Inflammatory Myopathies, Including Dermatomyositis and Polymyositis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?