Early access
Sign in
Taking people in United KingdomPhase 3

Anifrolumab injections for adults with polymyositis or dermatomyositis

Tests anifrolumab against placebo in adults with polymyositis or dermatomyositis.

Key facts

Who runs it
AstraZeneca
Where
Edinburgh, London, and Wolverhampton, United KingdomSee the 3 sitesAlso in 28 other countries, 190 sites
Trial code
Registry title
A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Status
Recruiting
Phase
Phase 3
People taking part
240 people, planned
Started
20 Jun 2024
Expected to end
9 Apr 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Anifrolumab (blinded)
  • Placebo
  • Anifrolumab (unblinded, open label)
Record updated
24 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with polymyositis or dermatomyositis (muscle inflammation diseases) that is moderate or severe. They must already be on stable treatment for it.

Age
18 to 75 years
Sex
All sexes
Disease stage
"Probable" or "definite" polymyositis or dermatomyositis by the 2017 ACR/EULAR criteria. Moderate or severe disease activity.
Earlier treatment
Must currently take oral prednisone or other polymyositis or dermatomyositis treatment at a stable dose.

Main reasons for not taking part

  • Other muscle diseases, such as inclusion body myositis, necrotizing myositis, drug-induced or cancer-related myositis, or muscular dystrophies
  • High risk of cancer, or a history of cancer (with some exceptions)
  • Fast-worsening lung scarring (interstitial lung disease)
  • HIV, hepatitis B, active hepatitis C, immune weakness, or a past severe shingles infection
  • Pregnant or breastfeeding, or planning to be

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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 adult myositis
  • Moderate or severe disease activity per core set measurements
  • Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose
  • No history of active tuberculosis or severe COVID-19
  • Male and female participants must follow contraception guidelines

Who cannot take part

  • 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)
  • Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF
  • Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization
  • Recent or concurrent enrollment in another clinical study with an investigational product
  • PM and DM patients at a high risk of malignancy
  • 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 the investigator's opinion
  • Any history of severe case of herpes zoster infection
  • History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV
  • Recent non-opportunistic infection requiring hospitalization or anti-infective treatment
  • Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Other criteria

  • Capable of giving informed consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United Kingdom

Also in 28 other countries, 190 sites

  • EdinburghHospital not named in the registryTaking people
  • LondonHospital not named in the registryTaking people
  • WolverhamptonHospital not named in the registryTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Anifrolumab (subcutaneous weekly injection)Treatment being tested

    Anifrolumab subcutaneous injection once weekly

    Treatment: Anifrolumab (blinded) and Anifrolumab (unblinded, open label)

  • Placebo (subcutaneous weekly injection)Placebo, for comparison

    Matched placebo control subcutaneous injection once weekly

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Plain-language title
Anifrolumab injections for adults with polymyositis or dermatomyositisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06455449, who can take part
Publications
Record updated
24 September 2026