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Study on Anifrolumab for Adults with Polymyositis or Dermatomyositis

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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 two specific diseases: Polymyositis and Dermatomyositis. These are types of idiopathic inflammatory myopathies, which are conditions that cause muscle inflammation and weakness. The study will evaluate the effectiveness and safety of a treatment called Anifrolumab, which is administered as a solution for injection. Anifrolumab is being compared to a placebo, both of which are added to the standard care that participants are already receiving.

The purpose of the study is to determine if Anifrolumab can provide a moderate improvement in disease activity over a period of 52 weeks. Participants will receive either Anifrolumab or a placebo through subcutaneous injections, which means the medication is injected under the skin. The study will follow a double-blind method, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will continue their usual treatments for Polymyositis or Dermatomyositis, and their progress will be monitored to assess any changes in their condition. The trial aims to provide valuable information on whether Anifrolumab can be a beneficial addition to the current standard of care for these conditions.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18-75 years), body weight (40 kg - ≤ 100 kg), and a diagnosis of polymyositis or dermatomyositis.

    Participants must have moderate or severe disease activity and be on a stable dose of oral prednisone or other treatments for these conditions.

  2. Step 2

    Treatment initiation

    Participants receive either anifrolumab or a placebo. Both are administered as a subcutaneous injection.

    The treatment is added to the standard care already being received by the participant.

  3. Step 3

    Treatment duration

    The treatment continues for a period of 52 weeks.

    Participants are monitored for any changes in disease activity and overall health.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to evaluate the improvement in disease activity.

    The primary goal is to achieve at least a moderate improvement in disease activity without meeting criteria for confirmed deterioration at two consecutive visits.

  5. Step 5

    End of study

    The study concludes after 52 weeks of treatment.

    Final assessments are conducted to determine the overall efficacy and safety of the treatment.

Who can join the trial?

7 criteria

  • Age between 18 and 75 years old.
  • Body weight between 40 kg and 100 kg.
  • Must have a "probable" or "definite" diagnosis of polymyositis (PM) or dermatomyositis (DM) according to specific medical guidelines from 2017. These are conditions that affect the muscles and skin.
  • Have moderate or severe disease activity based on certain medical measurements.
  • Currently taking oral prednisone or other treatments for polymyositis or dermatomyositis at a stable dose. Prednisone is a medication used to reduce inflammation.
  • No history of active tuberculosis or severe COVID-19. Tuberculosis is a serious infectious disease that mainly affects the lungs, and COVID-19 is a viral infection that can cause respiratory illness.
  • Male and female participants must follow guidelines for preventing pregnancy during the study.

Who cannot join the trial?

4 criteria

  • Patients who do not meet the 2017 EULAR/ACR classification criteria for polymyositis or dermatomyositis. These are specific guidelines used to diagnose these conditions.
  • Patients who are not within the specified age range for the study. The study has certain age limits that participants must fall within.
  • Patients who are not part of the specified clinical trial groups. The study is looking for participants from certain groups.
  • Patients who are considered part of a vulnerable population. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

Anifrolumab is a medication being studied for its effectiveness and safety in treating idiopathic inflammatory myopathies, specifically polymyositis and dermatomyositis. It is administered as a subcutaneous injection and is added to the standard care treatment. The goal of the trial is to see if anifrolumab can provide a moderate improvement in disease activity over a period of 52 weeks.

What is already known about the treatment

Anifrolumab – Anifrolumab is administered as a subcutaneous injection and is currently being studied in a Phase III clinical trial for its effectiveness and safety in treating idiopathic inflammatory myopathies, specifically polymyositis and dermatomyositis. It is being compared to a placebo, both added to standard care, to assess its ability to improve disease activity. Anifrolumab works by targeting and blocking the type I interferon receptor, which plays a role in the inflammatory process. It is classified as a monoclonal antibody and is being investigated for its potential to provide moderate improvement in these conditions.

Investigated diseases

  • Polymyositis

    Polymyositis is an inflammatory disease that causes muscle weakness, primarily affecting the muscles closest to the trunk of the body. It progresses gradually, leading to increasing difficulty in performing tasks such as climbing stairs, lifting objects, or rising from a seated position. The condition can also affect muscles involved in swallowing and breathing. Over time, the inflammation can cause muscle tissue to break down, resulting in muscle atrophy. The exact cause of polymyositis is unknown, but it is believed to involve an autoimmune response where the body's immune system attacks its own muscle fibers.

  • Dermatomyositis

    Dermatomyositis is a rare inflammatory disease characterized by muscle weakness and a distinctive skin rash. The rash often appears as a violet or dusky red discoloration, typically on the face, eyelids, knuckles, elbows, knees, chest, and back. Muscle weakness usually affects the muscles closest to the trunk, similar to polymyositis, and can progress over weeks or months. This weakness can make everyday activities challenging, such as lifting objects or climbing stairs. The cause of dermatomyositis is not fully understood, but it is thought to involve an autoimmune reaction.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504022-19-01Protocol codeD3463C00003, JASMINEEstimated enrolment204 patientsSponsorAstraZeneca AB

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