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NCT06455449 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Polymyositis, Dermatomyositis, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT06455449 is a Phase 3 study of Polymyositis, Dermatomyositis that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 240 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT06455449, a Phase 3 study of Polymyositis, Dermatomyositis, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-06-20 |
| Est. Completion | 2028-08-04 |
| Phase | Phase 3 |
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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, categorized as Phase 3. 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 1,285 total studies on file at ClinicalTrials.gov.
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.
NCT06455449 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Colorado, California.
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.
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).
Who is sponsoring clinical trial NCT06455449?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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.
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