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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 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)

NCT06455449

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Polymyositis, Dermatomyositis

Interventions: Anifrolumab (blinded), Placebo, Anifrolumab (unblinded, open label)

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (236)
  • Phoenix, Arizona, United States
  • Irvine, California, United States
  • Aurora, Colorado, United States
  • Denver, Colorado, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Boca Raton, Florida, United States
  • Boynton Beach, Florida, United States
  • Gainesville, Florida, United States
  • Margate, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Palm Beach Gardens, Florida, United States
  • Plant City, Florida, United States
  • Atlanta, Georgia, United States
  • Willowbrook, Illinois, United States
  • Fairway, Kansas, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Sterling Heights, Michigan, United States
  • Great Neck, New York, United States
  • Charlotte, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Middleburg Heights, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • + 206 more on CT.gov