Evaluating Anifrolumab for Treating Polymyositis and Dermatomyositis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, placebo-controlled, double-blind study aims to assess the efficacy and safety of subcutaneous anifrolumab in adults with moderate to severe idiopathic inflammatory myopathies, specifically polymyositis and dermatomyositis. Participants will receive either anifrolumab or a placebo alongside standard of care treatments. The study will measure overall disease activity using established core set measurements to determine the impact of anifrolumab compared to placebo.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Irvine, California, United States Recruiting
• Research Site
  Aurora, Colorado, United States Recruiting
• Research Site
  Denver, Colorado, United States Recruiting
• Research Site
  New Haven, Connecticut, United States Recruiting
• Research Site
  Boca Raton, Florida, United States Recruiting
• Research Site
  Margate, Florida, United States Recruiting

+187 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.