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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)

RecruitingPhase 3

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)

Who can join

Ages 18 to 75 · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: AstraZeneca · Participants: 240 · Started: Jun 20, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06455449

Locations in the U.S.

ArizonaResearch Site, Phoenix (Not yet recruiting)
CaliforniaResearch Site, Irvine
ColoradoResearch Site, Aurora
Research Site, Denver
ConnecticutResearch Site, New Haven
FloridaResearch Site, Boca Raton
Research Site, Margate
Research Site, Miami
Research Site, Orlando
Research Site, Palm Beach Gardens
Research Site, Plant City
GeorgiaResearch Site, Atlanta
IllinoisResearch Site, Willowbrook
KansasResearch Site, Fairway
MarylandResearch Site, Baltimore
MassachusettsResearch Site, Boston
MichiganResearch Site, Ann Arbor
Research Site, Sterling Heights
New YorkResearch Site, Great Neck
North CarolinaResearch Site, Charlotte
Research Site, Durham
OhioResearch Site, Cleveland
PennsylvaniaResearch Site, Philadelphia (Not yet recruiting)
Research Site, Pittsburgh
South CarolinaResearch Site, Charleston
Research Site, Summerville
TexasResearch Site, Allen
Research Site, Amarillo
Research Site, Austin
Research Site, Colleyville
Research Site, El Paso
Research Site, Harlingen
Research Site, North Richland Hills
WisconsinResearch Site, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.