Early access
Sign in
Taking people in HungaryPhase 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 AB
Where
Budapest, Budapest II, Debrecen, and Szeged, HungarySee the 4 sitesAlso in 12 other countries, 65 sites
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
84 people, planned
Started
13 Dec 2024
Expected to end
16 Jun 2028
Type of study
Interventional
Record updated
28 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 (PM) or dermatomyositis (DM), which are inflammatory muscle diseases. The disease must be moderately or severely active.

Age
18 - 75 years old
Sex
All sexes can join.
Disease stage
A "probable" or "definite" diagnosis of PM or DM by the 2017 ACR/EULAR criteria for adult myositis. The disease must be moderately or severely active. Body weight 40 kg (88 lb) - ≤ 100 kg (220 lb).
Earlier treatment
People must be taking oral prednisone or another PM or DM treatment at a stable dose.

Main reasons for not taking part

  • Other types of myositis, such as inclusion body myositis, necrotizing myositis, drug-induced or cancer-linked myositis, amyopathic DM, or muscular dystrophies.
  • Pregnant or breastfeeding women, or women planning pregnancy or breastfeeding.
  • Lung scarring that is getting worse quickly (rapidly progressive interstitial lung disease), or a high risk of cancer.
  • History of cancer, immunodeficiency, HIV, HBV, active HCV, active tuberculosis, severe COVID-19 or severe herpes zoster (shingles).
  • Serious recent infections, or taking part recently in another study of a test drug.

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 18 - 75 years old
  • Body weight 40 kg - ≤ 100 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)
  • Recent or concurrent enrollment in another clinical study with an investigational product
  • 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
  • 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

Where in Hungary

Also in 12 other countries, 65 sites

  • Semmelweis UniversityBudapest, HungaryTaking people
  • Betegapolo Irgalmasrend Budai Irgalmasrendi KorhazBudapest II, HungaryTaking people
  • University of DebrecenDebrecen, HungaryTaking people
  • University of SzegedSzeged, HungaryTaking people

About the trial

What the trial wants to find out

To demonstrate the superiority of anifrolumab to placebo on moderate improvement in disease activity at Week 52

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

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
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.
Record updated
28 September 2026