Last updated 43 days ago
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)
240 patients around the world
Available in Spain, Brazil, United States, Mexico
AstraZeneca
240Patients around the world
This study is for people with
Inflammatory Myopathies
Polymyositis
Dermatomyositis
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Capable of giving informed consent.18 - 75 years old.Body weight 40 kg - ≤ 100 kg.Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.Moderate or severe disease activity per core set measurements.Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.No history of active tuberculosis or severe COVID-19.Male and female participants must follow contraception guidelines.
- 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).PM and DM patients at a high risk of malignancy.Participants with rapidly progressive interstitial lung disease.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.Any history of severe case of herpes zoster infection.History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV.Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.Recent or concurrent enrollment in another clinical study with an investigational product.Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding.
StudyJASMINE
SponsorAstraZeneca
Conditions
PolymyositisDermatomyositis
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06455449
