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)
← catalyst calendarNCT06455449 · readout in 268 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
240estimated
Sites
236
Countries
Argentina, Australia, Austria +26
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-06-20 | actual | When the study began enrolling |
| Primary completion | 2027-05-14 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-08-04 | estimated | The whole study's end, after follow-up |
| First posted | 2024-06-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Polymyositis, Dermatomyositis
Interventions
- Combination product: Anifrolumab (blinded) — also filed as Treatment arm (blinded)
- Other: Placebo — also filed as Placebo arm (blinded)
- Combination product: Anifrolumab (unblinded, open label) — also filed as treatment arm (unblinded)
Primary outcome
what the primary-completion date above is the date OFTotal Improvement Score (TIS) ≥ 40 response
measured 52 week
Publications
- PMID 40297385 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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