Status:

RECRUITING

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)

Lead Sponsor:

AstraZeneca

Conditions:

Polymyositis, Dermatomyositis

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief 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 a...

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

Key Trial Info

Start Date :

June 20 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 4 2028

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT06455449

Start Date

June 20 2024

End Date

August 4 2028

Last Update

March 19 2026

Active Locations (228)

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Page 1 of 57 (228 locations)

1

Research Site

Irvine, California, United States, 92617

2

Research Site

Aurora, Colorado, United States, 80045

3

Research Site

Denver, Colorado, United States, 80230

4

Research Site

New Haven, Connecticut, United States, 06519

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) | DecenTrialz