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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

7 criteria

  • 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.
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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.

What is already known about the treatment

Dazukibart – Dazukibart is administered as an injection, typically given under the skin or into a vein, depending on the specific treatment protocol. It is currently being studied in clinical trials, particularly in a Phase 3 study, to assess its long-term safety, tolerability, and effectiveness in treating idiopathic inflammatory myopathies, including dermatomyositis and polymyositis. These conditions are characterized by muscle inflammation and weakness. Dazukibart works by modulating the immune system to reduce inflammation at the molecular level, although the exact mechanism is still under investigation. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514648-10-00Protocol codeC0251010Estimated enrolment184 patientsSponsorPfizer Inc.

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