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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Anifrolumab (blinded): Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Placebo: Matched placebo delivered subcutaneously, once weekly for 52 weeks
Anifrolumab (unblinded, open label): At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
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.
Eligibility
Primary outcome measure(s)
- Total Improvement Score (TIS) ≥ 40 response — 52 week
Participants who have at least moderate improvement in disease activity TIS ≥ 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits
Trial sites (237)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Phoenix | Arizona | Not Yet Recruiting |
| Research Site | Irvine | California | Recruiting |
| Research Site | Aurora | Colorado | Recruiting |
| Research Site | Denver | Colorado | Recruiting |
| Research Site | New Haven | Connecticut | Recruiting |
| Research Site | Washington D.C. | District of Columbia | Withdrawn |
| Research Site | Boca Raton | Florida | Recruiting |
| Research Site | Boynton Beach | Florida | Withdrawn |
| Research Site | Gainesville | Florida | Withdrawn |
| Research Site | Margate | Florida | Recruiting |
| Research Site | Miami | Florida | Withdrawn |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Orlando | Florida | Recruiting |
| Research Site | Palm Beach Gardens | Florida | Recruiting |
| Research Site | Plant City | Florida | Recruiting |
| Research Site | Atlanta | Georgia | Recruiting |
| Research Site | Willowbrook | Illinois | Recruiting |
| Research Site | Fairway | Kansas | Recruiting |
| Research Site | Baltimore | Maryland | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Ann Arbor | Michigan | Recruiting |
| Research Site | Sterling Heights | Michigan | Recruiting |
| Research Site | Great Neck | New York | Recruiting |
| Research Site | Charlotte | North Carolina | Withdrawn |
| Research Site | Charlotte | North Carolina | Recruiting |
| Research Site | Durham | North Carolina | Recruiting |
| Research Site | Cleveland | Ohio | Recruiting |
| Research Site | Middleburg Heights | Ohio | Withdrawn |
| Research Site | Philadelphia | Pennsylvania | Not Yet Recruiting |
| Research Site | Pittsburgh | Pennsylvania | Recruiting |
| Research Site | Charleston | South Carolina | Recruiting |
| Research Site | Summerville | South Carolina | Recruiting |
| Research Site | Allen | Texas | Recruiting |
| Research Site | Amarillo | Texas | Recruiting |
| Research Site | Austin | Texas | Recruiting |
| Research Site | Colleyville | Texas | Recruiting |
| Research Site | El Paso | Texas | Recruiting |
| Research Site | Galveston | Texas | Withdrawn |
| Research Site | Harlingen | Texas | Recruiting |
| Research Site | Houston | Texas | Withdrawn |
+ 197 more sites — see the full list on the official registry below.
More AstraZeneca trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06455449 on ClinicalTrials.gov ↗ ← All trials in Italy