Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Polymyositis, Dermatomyositis, sponsored by AstraZeneca.
NCT06455449 is a Phase 3 study of Polymyositis, Dermatomyositis that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants who have at least moderate improvement in disease activity TIS ≥ 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits
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 |
What NCT06455449 shows while recruiting
NCT06455449 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06455449's enrollment target sits among peer trials
240 1274th of 2000 higher than 710 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02855554 · 240 participants · NA
Quantitative Cardiac Parametric Mapping
- NCT03230565 · 240 participants · Phase 4
Continuous Infusions vs Scheduled Bolus Infusions
- NCT03399929 · 240 participants
Traumatic Brain Injury and Stroke Long Term Outcome
- NCT03583710 · 240 participants · Phase 3
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI