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Taking people in ItalyPhase 3

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)

Key facts

Who runs it
AstraZeneca
Where
Ancona, Bari, Catania, Milan, Padova, Palermo, Pavia, Pisa, Roma, Rozzano, and Siena, ItalySee the 11 sitesAlso in 28 other countries, 182 sites
Trial code
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

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

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 Italy

Also in 28 other countries, 182 sites

  • AnconaHospital not named in the registryTaking people
  • BariHospital not named in the registryTaking people
  • CataniaHospital not named in the registryTaking people
  • MilanHospital not named in the registryTaking people
  • PadovaHospital not named in the registryTaking people
  • PalermoHospital not named in the registryNo longer taking part
  • PaviaHospital not named in the registryTaking people
  • PisaHospital not named in the registryNo longer taking part
  • RomaHospital not named in the registryNo longer taking part
  • RozzanoHospital not named in the registryTaking people
  • SienaHospital not named in the registryNo longer taking part

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)
Fit questions
Built from NCT06455449, who can take part
Record updated
24 September 2026