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)
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)
- Polymyositis, Dermatomyositis
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- AstraZeneca
- Enrolment target
- 240
- Started
- 20 June 2024
- Main results due
- 10 January 2028
- Study sites
- 237
- Registry updated
- 24 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(237)
Research Site
Phoenix, Arizona, United States
Not yet recruiting
Research Site
Irvine, California, United States
Recruiting
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Aurora, Colorado, United States
Recruiting
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Denver, Colorado, United States
Recruiting
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New Haven, Connecticut, United States
Recruiting
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Washington D.C., District of Columbia, United States
Withdrawn
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Boca Raton, Florida, United States
Recruiting
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Boynton Beach, Florida, United States
Withdrawn
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Gainesville, Florida, United States
Withdrawn
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Margate, Florida, United States
Recruiting
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Miami, Florida, United States
Withdrawn
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Miami, Florida, United States
Recruiting
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Orlando, Florida, United States
Recruiting
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Palm Beach Gardens, Florida, United States
Recruiting
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Plant City, Florida, United States
Recruiting
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Atlanta, Georgia, United States
Recruiting
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Willowbrook, Illinois, United States
Recruiting
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Fairway, Kansas, United States
Recruiting
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Baltimore, Maryland, United States
Recruiting
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Boston, Massachusetts, United States
Recruiting
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Ann Arbor, Michigan, United States
Recruiting
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Sterling Heights, Michigan, United States
Recruiting
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Great Neck, New York, United States
Recruiting
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Charlotte, North Carolina, United States
Withdrawn
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Charlotte, North Carolina, United States
Recruiting
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Durham, North Carolina, United States
Recruiting
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Cleveland, Ohio, United States
Recruiting
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Middleburg Heights, Ohio, United States
Withdrawn
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Philadelphia, Pennsylvania, United States
Not yet recruiting
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Pittsburgh, Pennsylvania, United States
Recruiting
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Charleston, South Carolina, United States
Recruiting
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Summerville, South Carolina, United States
Recruiting
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Allen, Texas, United States
Recruiting
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Amarillo, Texas, United States
Recruiting
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Austin, Texas, United States
Recruiting
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Colleyville, Texas, United States
Recruiting
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El Paso, Texas, United States
Recruiting
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Galveston, Texas, United States
Withdrawn
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Harlingen, Texas, United States
Recruiting
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Houston, Texas, United States
Withdrawn
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North Richland Hills, Texas, United States
Recruiting
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Beckley, West Virginia, United States
Withdrawn
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Milwaukee, Wisconsin, United States
Recruiting
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Buenos Aires, Argentina
Recruiting
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CABA, Argentina
Recruiting
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Ciudad de Buenos Aires, Argentina
Recruiting
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Quilmes, Argentina
Recruiting
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San Miguel de Tucumán, Argentina
Recruiting
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Camperdown, Australia
Recruiting
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Nedlands, Australia
Recruiting
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New Lambton, Australia
Withdrawn
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Southport, Australia
Recruiting
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Woodville South, Australia
Recruiting
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Graz, Austria
Recruiting
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Vienna, Austria
Recruiting
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Ghent, Belgium
Recruiting
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Leuven, Belgium
Recruiting
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Merksem, Belgium
Withdrawn
Research Site
Joinville, Brazil
Recruiting
Research Site
Juiz de Fora, Brazil
Recruiting
Showing 60 of 237 sites — filter to narrow it down. 180 of the 237 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06455449. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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