Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Michelle Min (uci)

Description

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.

Official Title

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)

Keywords

Polymyositis, Dermatomyositis, Polymyositis, Dermatomyositis, anifrolumab, Anifrolumab (blinded), Anifrolumab (unblinded, open label)

Eligibility

For people ages 18-75

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

  • Research Site accepting new patients
    Irvine California 92617 United States
  • Research Site not yet accepting patients
    Phoenix Arizona 85032 United States
  • Research Site accepting new patients
    El Paso Texas 79902 United States

Lead Scientist at University of California Health

  • Michelle Min (uci)
    Associate Clinical Professor, Dermatology, School of Medicine. Authored (or co-authored) 24 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT06455449
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated