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RECRUITING Phase 3

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)

NCT06455449 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • OTHER Placebo
  • COMBINATION_PRODUCT Anifrolumab (blinded)
  • COMBINATION_PRODUCT Anifrolumab (unblinded, open label)

Study Locations (20)

Florida

  • Research Site — Boca Raton
  • Research Site — Boynton Beach
  • Research Site — Gainesville
  • Research Site — Margate
  • Research Site — Miami
  • Research Site — Miami
  • Research Site — Orlando
  • Research Site — Palm Beach Gardens
  • Research Site — Plant City

Colorado

  • Research Site — Aurora
  • Research Site — Denver

California

  • Research Site — Irvine

Connecticut

  • Research Site — New Haven

District of Columbia

  • Research Site — Washington D.C.

Georgia

  • Research Site — Atlanta

Illinois

  • Research Site — Willowbrook

Kansas

  • Research Site — Fairway

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2024-06-20
Est. Completion 2028-08-04
Phase Phase 3

Sponsor

AstraZeneca

1,053 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06455449

The ClinicalTrials.gov registry entry for NCT06455449 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Polymyositis, Dermatomyositis appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06455449 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Colorado, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06455449 about?

NCT06455449 is a clinical study titled "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)". 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) \[polymyosi...

What is the current status of trial NCT06455449?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2024-06-20. Estimated completion is 2028-08-04.

What conditions does trial NCT06455449 study?

This clinical trial studies the following conditions: Polymyositis, Dermatomyositis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06455449?

The interventions under investigation include: Placebo (OTHER), Anifrolumab (blinded) (COMBINATION_PRODUCT), Anifrolumab (unblinded, open label) (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06455449?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06455449 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial