At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Anifrolumab (blinded) (combination product), Placebo (other), Anifrolumab (unblinded, open label) (combination product)
- How long the study runs
- Study runs about 58 months (dates as stated)
- About the drug or intervention
- Anifrolumab (blinded) — combination product: Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks · Placebo — other: Matched placebo delivered subcutaneously, once weekly for 52 weeks · Anifrolumab (unblinded, open label) — combination product: At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by AstraZeneca, is testing a medicine called anifrolumab, given as an injection under the skin, in adults with idiopathic inflammatory myopathies (polymyositis and dermatomyositis) — conditions that cause muscle inflammation. It will compare anifrolumab added to people's usual care with a placebo (a dummy injection with no medicine) added to usual care, to see how well it works and how safe it is.
Who can take part
- Aged 18 to 75 years
- Body weight of 40 kg or more
- A 'probable' or 'definite' diagnosis of polymyositis or dermatomyositis based on 2017 ACR/EULAR criteria (standard rules doctors use to classify adult myositis)
- Moderate or severe disease activity
- Currently taking prednisone (a steroid tablet) or other myositis treatments at a steady dose
- Able to give informed consent
- No history of active tuberculosis (TB) or severe COVID-19
- Following contraception guidelines if male or female
- Not pregnant, breastfeeding, or planning to become pregnant or breastfeed
Who may not be able to
- Diagnosis of certain other muscle conditions: inclusion body myositis (IBM), immune-mediated necrotising myositis (IMNM), juvenile myositis diagnosed within the last 10 years, drug-induced myositis, cancer-associated myositis, amyopathic dermatomyositis, or non-inflammatory muscle diseases such as muscular dystrophies
- High risk of cancer
- Rapidly worsening interstitial lung disease (scarring of the lungs)
- Severe muscle damage or permanent weakness from another condition, such as a stroke
- Past severe shingles (herpes zoster) infection
- History of cancer (except adequately treated basal cell skin cancer or cervical cancer that has not spread), immunodeficiency, HIV, hepatitis B, or active hepatitis C
- Cytomegalovirus (CMV) or Epstein-Barr virus infection that has not fully cleared within 12 weeks before signing the consent form
- An opportunistic infection (an infection that takes hold when the immune system is weak) needing hospital stays or drip (IV) medicine within the past 3 years
- A recent infection needing a hospital stay or anti-infection treatment
- Recently enrolled, or currently enrolled, in another clinical study of an experimental treatment
What taking part involves
- • An injection of anifrolumab under the skin (subcutaneous injection) or a placebo (dummy injection), added to your standard care
- • Standard care treatment continues as before, at a stable dose
Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 240
- Started
- 2024-06-20
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for polymyositis, dermatomyositis
- • Phase3 - 240 participants
- • The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with polymyositis, dermatomyositis
Where?
- • Edinburgh - Research Site
- • London - Research Site
- • Wolverhampton - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.
Polymyositis, Dermatomyositis
How this trial compares with your answers
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓18 - 75 years old
- ✓Body weight ≥40 kg
- ✓Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for...
- ✓Moderate or severe disease activity per core set measurements.
- ✓Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
Who cannot take part
- ✗PM and DM patients at a high risk of cancer.
- ✗Participants with rapidly progressive interstitial lung disease.
- ✗Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per...
- ✗Any history of severe case of herpes zoster infection
- ✗History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency,...
See the full criteria
Capable of giving informed consent.
Inclusion Criteria:
1. 18 - 75 years old
2. Body weight ≥40 kg
3. Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
4. Moderate or severe disease activity per core set measurements.
5. Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
6. No history of active tuberculosis or severe COVID-19.
7. Male and female participants must follow contraception guidelines.
Exclusion Criteria:
1. Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies).
2. PM and DM patients at a high risk of malignancy.
3. Participants with rapidly progressive interstitial lung disease.
4. Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion.
5. Any history of severe case of herpes zoster infection
6. History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
8. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
9. Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
10. Recent or concurrent enrollment in another clinical study with an investigational product.
11. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding
Where Is This Study? (3 UK sites)
Research Site
Edinburgh EH4 2XU, United Kingdom
Research Site
London NW3 2QG, United Kingdom
Research Site
Wolverhampton WV10 0QP, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07