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)

Description

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.

Conditions

Polymyositis, Dermatomyositis

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Study Overview

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Study Details

Study overview

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.

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)

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)

Condition
Polymyositis, Dermatomyositis
Intervention / Treatment

-

Contacts and Locations

Orange

Research Site, Orange, California, United States, 92868

New Haven

Research Site, New Haven, Connecticut, United States, 06519

Washington

Research Site, Washington, District of Columbia, United States, 20037

Boca Raton

Research Site, Boca Raton, Florida, United States, 33486

Boynton Beach

Research Site, Boynton Beach, Florida, United States, 33472

Gainesville

Research Site, Gainesville, Florida, United States, 32608

Miami

Research Site, Miami, Florida, United States, 33126

Atlanta

Research Site, Atlanta, Georgia, United States, 30322

Fairway

Research Site, Fairway, Kansas, United States, 66205

Ann Arbor

Research Site, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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.
  • 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2028-08-04