Anifrolumab for Polymyositis and Dermatomyositis

This study is testing anifrolumab, given as a shot under the skin, to see if it's safe and effective for adults with moderate to severe polymyositis (PM) or dermatomyositis (DM). You would receive either anifrolumab or a placebo (an inactive substance) for 52 weeks, in addition to your usual care. After that, everyone will receive open-label anifrolumab for another 52 weeks. Researchers will measure how much your symptoms improve using a score called the Total Improvement Score (TIS) after 52 weeks. The study plans to enroll 240 participants, aged 18 to 75, who have a confirmed diagnosis of PM or DM. The current recruitment status is unclear.

Study design
This is a multicenter, randomized, placebo-controlled, and double-blind study, meaning participants are randomly assigned to a treatment group and neither you nor your doctor will know which treatment you are receiving initially. The study plans to enroll 240 participants.
What's involved
You would receive weekly subcutaneous (under the skin) injections for 52 weeks, followed by another 52 weeks of open-label injections.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 52 weeks, and participants will continue to receive treatment for an additional 52 weeks after that.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06455449

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)

Recruiting
PHASE3Ages 18–75InterventionalTreatment
AstraZeneca
~240 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:Anifrolumab (blinded)PlaceboAnifrolumab (unblinded, open label)

At a glance

Recruiting sites
174 of 236 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total Improvement Score (TIS) ≥ 40 response
Measured over 52 week
Polymyositis, Dermatomyositis
236 sites across 49 states
China19
Japan17
India15
Italy14
France11
Spain10
Florida9
Texas9
AstraZeneca Clinical Study Information Center
Email the study team

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  • Total Improvement Score (TIS) ≥ 40 response52 week

    Participants who have at least moderate improvement in disease activity TIS ≥ 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits