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
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.
| 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 | Not Yet 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| Research Site | Washington D.C. | District of Columbia | Withdrawn |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| Research Site | Boynton Beach | Florida | Withdrawn |
| Research Site | Gainesville | Florida | Withdrawn |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 | Suspended |
| Research Site | Miami | Florida | Withdrawn |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 | Not Yet Recruiting |
| Research Site | Ann Arbor | Michigan | Recruiting |
| Research Site | Sterling Heights | Michigan | Not Yet Recruiting |
| Research Site | Great Neck | New York | Not Yet 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| Research Site | Charlotte | North Carolina | Withdrawn |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| Research Site | Middleburg Heights | Ohio | Withdrawn |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 | Not Yet 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 |
+ 196 more sites — see the full list on the official registry below.
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 India