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Study on Nipocalimab for Adults with Active Inflammatory Muscle Diseases

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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 a group of diseases known as Idiopathic Inflammatory Myopathies (IIM). These are rare conditions that cause muscle inflammation and weakness. The study will evaluate a treatment called nipocalimab, which is being tested to see if it can help people with active IIM. Nipocalimab is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to assess how effective and safe nipocalimab is compared to a placebo in treating IIM. Participants in the study will receive either nipocalimab or a placebo, and the effects will be monitored over a period of time. The study will last for up to 52 weeks, during which participants will have regular check-ups to track their progress and any changes in their condition.

Throughout the study, researchers will look for improvements in muscle strength and overall health. The goal is to determine if nipocalimab can provide significant benefits for those living with IIM, potentially offering a new treatment option for managing this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm the diagnosis of idiopathic inflammatory myopathies (IIM). This involves meeting specific diagnostic criteria established by medical guidelines.

    The assessment includes checking for the presence of certain antibodies related to the condition. If the initial test results are inconclusive, a retest may be required.

  2. Step 2

    Stabilization of current treatment

    If currently using low potency topical treatments for skin lesions, the dosage and frequency must remain stable for at least four weeks before starting the study medication. This stability must be maintained until Week 52 of the study.

  3. Step 3

    Medication administration

    The study involves the administration of nipocalimab or a placebo. Nipocalimab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

    The specific dosage and frequency of administration will be determined by the study protocol and communicated during the trial.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, regular monitoring is conducted to evaluate the effectiveness and safety of the treatment. This includes assessing improvements in symptoms and any potential side effects.

    The primary goal is to achieve at least a minimal improvement in the condition by Week 52, with a reduction in the use of oral prednisone or its equivalent.

  5. Step 5

    Completion of study

    The study is expected to conclude by March 2027. At the end of the study, a final assessment will be conducted to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

6 criteria

  • The participant must have a condition called **Active Idiopathic Inflammatory Myopathies (IIM)**, which is a type of muscle inflammation.
  • The participant must meet specific criteria for diagnosing IIM, based on guidelines from 2017, at least 6 weeks before starting the study treatment.
  • If the participant is using certain skin treatments like low-strength topical glucocorticoids or topical tacrolimus, the dose and frequency must be stable for at least 4 weeks before starting the study treatment and should remain the same until Week 52 of the study.
  • The participant must have specific antibodies related to muscle inflammation. These are proteins in the blood that can indicate certain types of muscle inflammation. If the tests for these antibodies are negative or show more than one type, they will be repeated. If the same results occur again, the participant cannot join the study.
  • Both male and female participants are eligible for the study.
  • The study includes participants from vulnerable populations, which means people who might need extra protection or care.

Who cannot join the trial?

10 criteria

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or breastfeeding.
  • Having a history of severe allergic reactions to medications.
  • Using certain medications that might affect the study results.
  • Having a recent infection that requires treatment.
  • Having a history of drug or alcohol abuse.
  • Participating in another clinical trial recently.
  • Having a condition that affects the immune system, which is the body's defense against illness.
  • Having a history of cancer, except for some types of skin cancer.
  • Having a blood disorder, which is a problem with the blood.
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Investigated drugs

Nipocalimab is a medication being studied for its potential to help people with active idiopathic inflammatory myopathies, which are a group of diseases that cause muscle inflammation and weakness. The trial aims to see how effective and safe nipocalimab is for treating these conditions.

What is already known about the treatment

Nipocalimab – Nipocalimab is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials and is not yet widely available in medical practice. The main therapeutic indication for nipocalimab is the treatment of active idiopathic inflammatory myopathies, which are a group of muscle diseases characterized by inflammation. At the molecular level, nipocalimab works by targeting and blocking specific proteins involved in the immune response, helping to reduce inflammation. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

Idiopathic Inflammatory Myopathies – These are a group of rare muscle diseases characterized by chronic muscle inflammation and weakness. The exact cause is unknown, but they are believed to involve the immune system attacking the body's own muscle tissues. Symptoms often include muscle pain, fatigue, and difficulty with movements such as climbing stairs or lifting objects. Over time, the muscle weakness can progress, affecting daily activities and quality of life. The condition can vary greatly in severity and may involve other organs, such as the skin or lungs. Diagnosis is typically based on clinical evaluation, muscle biopsy, and other tests to rule out other conditions.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505314-20-00Protocol code80202135IIM2001Estimated enrolment191 patientsSponsorJanssen Cilag International

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