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)

Last updated: February 24, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Idiopathic Inflammatory Myopathies

Lupus

Collagen Vascular Diseases

Treatment

Anifrolumab (unblinded, open label)

Placebo

Anifrolumab (blinded)

Clinical Study ID

NCT06455449
D3463C00003
  • Ages 18-75
  • All Genders

Study Summary

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 Criteria

Inclusion

Capable of giving informed consent.

Inclusion Criteria:

  1. 18 - 75 years old

  2. Body weight 40 kg - ≤ 100 kg

  3. Must have "probable" or "definite" diagnosis of PM or DM according to the 2017ACR/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 dermatomyositistreatments at a stable dose.

  6. No history of active tuberculosis or severe COVID-19.

  7. Male and female participants must follow contraception guidelines.

Exclusion

Exclusion Criteria:

  1. Participants with documented inclusion body myositis (IBM), immune mediationnecrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years priorto signing the ICF), drug-induced myositis, cancer associated myositis, amyopathicDM, 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-DMconditions (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 cancerin-situ), immunodeficiency, HIV, HBV, active HCV .

  7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completelyresolved within 12 weeks prior to signing the ICF.

  8. Opportunistic infection requiring hospitalization or IV antimicrobial treatmentwithin 3 years prior to randomization.

  9. Recent non-opportunistic infection requiring hospitalization or anti-infectivetreatment.

  10. Recent or concurrent enrollment in another clinical study with an investigationalproduct.

  11. Lactating, breastfeeding, or pregnant females or females who intend to becomepregnant or begin breastfeeding

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Anifrolumab (unblinded, open label)
Phase: 3
Study Start date:
June 20, 2024
Estimated Completion Date:
August 04, 2028

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    Camperdown, 2050
    Australia

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    Nedlands, 6009
    Australia

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    New Lambton, 2310
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    Woodville South, 5011
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    Graz, 8036
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    Gent, 9000
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    Leuven, 3000
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    Merksem, B-2170
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    Joinville, 89202-190
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    Juiz de Fora, 36010 570
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    Pelotas, 96040-010
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    Porto Alegre, 90620-110
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    Salvador, 40150-150
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    Sao Jose Do Rio Preto, 15090-000
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    Sao Paulo, 01233-907
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    Haskovo, 6304
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    Milwaukee, Wisconsin 53226
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    Ha Noi, 100000
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    Hanoi, 100000
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    Hue, 530000
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