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)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Polymyositis, Dermatomyositis

In brief

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.

Key facts

Study ID: NCT06455449
Run by: AstraZeneca
People needed: 240
Starts: 2024-06-20
Expected to finish: 2028-08-04
Last updated by the study team: 2026-05-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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).
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 .
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 non-opportunistic infection requiring hospitalization or anti-infective treatment.
Recent or concurrent enrollment in another clinical study with an investigational product.
Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Where it is running

Research Site — Colleyville, Texas, United States (enrolling)
Research Site — Harlingen, Texas, United States (enrolling)
Research Site — Cleveland, Ohio, United States (enrolling)
Research Site — Austin, Texas, United States (enrolling)
Research Site — El Paso, Texas, United States (enrolling)
Research Site — Boca Raton, Florida, United States (enrolling)
Research Site — Irvine, California, United States (enrolling)
Research Site — Durham, North Carolina, United States (enrolling)
Research Site — Pittsburgh, Pennsylvania, United States (enrolling)
Research Site — Allen, Texas, United States (enrolling)
Research Site — Aurora, Colorado, United States (enrolling)
Research Site — Orlando, Florida, United States (enrolling)
Research Site — Palm Beach Gardens, Florida, United States (enrolling)
Research Site — Plant City, Florida, United States (enrolling)
Research Site — Atlanta, Georgia, United States (enrolling)
Research Site — Willowbrook, Illinois, United States (enrolling)
Research Site — Fairway, Kansas, United States (enrolling)
Research Site — Baltimore, Maryland, United States (enrolling)
Research Site — New Haven, Connecticut, United States (enrolling)
Research Site — Ann Arbor, Michigan, United States (enrolling)
Research Site — Charleston, South Carolina, United States (enrolling)
Research Site — Summerville, South Carolina, United States (enrolling)
Research Site — Miami, Florida, United States (enrolling)
Research Site — Charlotte, North Carolina, United States (enrolling)
Research Site — North Richland Hills, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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