Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

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

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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, 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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    After joining the study, you will receive either the test medication, known as PF-06823859, or a placebo, which is an inactive substance that looks like the medicine.

    The test medication (PF-06823859) or the placebo will be given to you through an intravenous administration, which means it is delivered directly into a vein using a needle or a small tube.

  2. Step 2

    Background medication use

    During the study, you may continue to take certain background medications to manage your condition.

    These medications may include methotrexate (taken by injection or by mouth), prednisolone or prednisone (taken by mouth), hydroxychloroquine (taken by mouth), methylprednisolone (taken by mouth or injection into a muscle), azathioprine (taken by mouth), dexamethasone (taken by injection), mycophenolate mofetil (taken by mouth), triamcinolone acetonide (given under the skin), deflazacort (taken by mouth), hydrocortisone (taken by mouth), leflunomide (taken by mouth), budesonide (taken by mouth), betamethasone (taken by mouth or injection), or chloroquine (taken by mouth).

  3. Step 3

    Monitoring and evaluation

    Your progress will be monitored over several weeks to evaluate how the medication affects your muscle symptoms.

    At week 24, changes in muscle strength and skin severity will be assessed.

    At week 52, the improvement in total muscle symptoms will be evaluated.

Who can join the trial?

11 criteria

  • 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 trial?

6 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

  • Methotrexate

    This medication can be taken by mouth or given as an injection into a vein. It is a well-established treatment used to manage various autoimmune and inflammatory conditions. At a molecular level, it works by interfering with the production of certain substances that help cells grow, which in turn reduces inflammation. It is pharmacologically classified as an antimetabolite and an immunosuppressant.

  • Prednisolone

    This medicine is administered orally as a pill or capsule. It is a common, widely used steroid for treating many inflammatory and allergic conditions. It works by mimicking natural hormones to dampen the body's immune response and reduce swelling. It is pharmacologically classified as a corticosteroid.

  • Hydroxychloroquine sulfate

    This medication is taken orally. It is a standard treatment used in medical practice to manage several autoimmune diseases. It works by affecting how certain immune cells respond to triggers, thereby decreasing inflammation. It is pharmacologically classified as an antimalarial and an immunomodulator.

  • Prednisone

    This is an oral medication used to treat various inflammatory and autoimmune disorders. It is a common steroid widely recognized in medical literature. It functions by blocking the production of chemicals that cause inflammation in the body. It is pharmacologically classified as a corticosteroid.

  • Dazukibart

    This is an experimental medication administered through an intravenous injection. It is currently being studied in clinical trials for its potential to treat specific immune system diseases. It works by targeting and blocking specific proteins involved in the inflammatory process. It is pharmacologically classified as a monoclonal antibody.

  • Methylprednisolone

    This medication can be taken by mouth or injected into a muscle. It is a well-known steroid used to treat many different inflammatory conditions. It acts by regulating the immune system to reduce swelling and irritation. It is pharmacologically classified as a corticosteroid.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502739-20-00Protocol codeC0251006Estimated enrolment318 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.