A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
Condition(s) studied
Investigational drug(s) / intervention(s)
Anifrolumab: Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).
Placebo: Matching placebo solution for injection in aPFS.
Study summary
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).
Eligibility
Primary outcome measure(s)
- Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score — At Week 24
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. It consists of 2 separate scores: i) activity of the disease, and ii) measure of damage. The CLASI instrument will be used at each study visit to capture individual skin manifestation scores. CLASI-70 responder (Yes/No) is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.
Trial sites (188)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Phoenix | Arizona | |
| Research Site | Covina | California | |
| Research Site | La Jolla | California | |
| Research Site | Los Angeles | California | |
| Research Site | Los Angeles | California | |
| Research Site | Orange | California | |
| Research Site | San Francisco | California | |
| Research Site | Aurora | Colorado | |
| Research Site | New Haven | Connecticut | |
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Fort Lauderdale | Florida | |
| Research Site | Miami | Florida | |
| Research Site | Plantation | Florida | |
| Research Site | Chicago | Illinois | |
| Research Site | Chicago | Illinois | |
| Research Site | Indianapolis | Indiana | |
| Research Site | Baltimore | Maryland | |
| Research Site | Boston | Massachusetts | |
| Research Site | Boston | Massachusetts | |
| Research Site | Ann Arbor | Michigan | |
| Research Site | Bloomfield Hills | Michigan | |
| Research Site | Rochester | Minnesota | |
| Research Site | Omaha | Nebraska | |
| Research Site | New York | New York | |
| Research Site | Rochester | New York | |
| Research Site | Charlotte | North Carolina | |
| Research Site | Statesville | North Carolina | |
| Research Site | Cleveland | Ohio | |
| Research Site | Portland | Oregon | |
| Research Site | Providence | Rhode Island | |
| Research Site | Charleston | South Carolina | |
| Research Site | Dallas | Texas | |
| Research Site | Charlottesville | Virginia | |
| Research Site | Roanoke | Virginia | |
| Research Site | Ciudad de Buenos Aires | Argentina | |
| Research Site | Córdoba | Argentina | |
| Research Site | Córdoba | Argentina | |
| Research Site | Quilmes | Argentina | |
| Research Site | San Miguel | Argentina | |
| Research Site | Kogarah | Australia |
+ 148 more sites — see the full list on the official registry below.
On this site
📄 Saphnelo (anifrolumab) drug profile →More AstraZeneca trials in Italy
Other trials for the same condition
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 NCT06015737 on ClinicalTrials.gov ↗ ← All trials in Italy