Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Condition(s) studied
Investigational drug(s) / intervention(s)
Placebo: Placebo s.c. monthly
Ianalumab: Ianalumab s.c. monthly Ianalumab s.c. quarterly
Study summary
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
Eligibility
Primary outcome measure(s)
- Number of treatment-emergent Adverse events/Serious Adverse events — through study completion, up to approximately 324 weeks
Assessment of long-term safety and tolerability of ianalumab
Trial sites (164)
| Facility | City | Region | Status |
|---|---|---|---|
| Pinnacle Research Group Llc | Anniston | Alabama | Recruiting |
| Providence Medical Center | Burbank | California | Recruiting |
| Advanced Medical Research | La Palma | California | Recruiting |
| Millennium Clinical Trials | Westlake Village | California | Active Not Recruiting |
| University of Colorado Denver | Aurora | Colorado | Recruiting |
| Clinical Res Of W Florida | Clearwater | Florida | Recruiting |
| GNP Research | Cooper City | Florida | Recruiting |
| Homestead Assoc In Research Inc | Homestead | Florida | Recruiting |
| IRIS Research and Development | Plantation | Florida | Recruiting |
| Clinical Research of West Florida Inc | Tampa | Florida | Recruiting |
| Parris and Associates Rheumatology | Lawrenceville | Georgia | Recruiting |
| Robert A Hozman MD SC | Skokie | Illinois | Completed |
| Willow Rheumatology Wellness | Willowbrook | Illinois | Recruiting |
| Accurate Clinical Research | Lake Charles | Louisiana | Recruiting |
| UMC New Orleans | New Orleans | Louisiana | Active Not Recruiting |
| University Of Maryland | Baltimore | Maryland | Active Not Recruiting |
| Henry Ford Health | Detroit | Michigan | Recruiting |
| Ahmed Arif Medical Research Center | Grand Blanc | Michigan | Recruiting |
| Paramount Med Rsrch and Consult LLC | Middleburg Heights | Ohio | Recruiting |
| University Of Pittsburgh | Pittsburgh | Pennsylvania | Recruiting |
| West Tennessee Research Institute | Jackson | Tennessee | Recruiting |
| Shelby Research LLC | Memphis | Tennessee | Recruiting |
| Novel Research LLC | Bellaire | Texas | Recruiting |
| Accurate Clinical Research | League City | Texas | Recruiting |
| Epic Medical Research | Red Oak | Texas | Recruiting |
| Novartis Investigative Site | La Plata | Buenos Aires | Recruiting |
| Novartis Investigative Site | Quilmes | Buenos Aires | Recruiting |
| Novartis Investigative Site | San Miguel | Buenos Aires | Active Not Recruiting |
| Novartis Investigative Site | San Miguel | Tucumán Province | Active Not Recruiting |
| Novartis Investigative Site | Caba | Argentina | Active Not Recruiting |
| Novartis Investigative Site | Caba | Argentina | Recruiting |
| Novartis Investigative Site | San Miguel de Tucumán | Argentina | Active Not Recruiting |
| Novartis Investigative Site | Maroochydore | Queensland | Recruiting |
| Novartis Investigative Site | Vitória | Espírito Santo | Recruiting |
| Novartis Investigative Site | Salvador | Estado de Bahia | Recruiting |
| Novartis Investigative Site | Belo Horizonte | Minas Gerais | Active Not Recruiting |
| Novartis Investigative Site | Niterói | Rio de Janeiro | Active Not Recruiting |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | Recruiting |
| Novartis Investigative Site | Barretos | São Paulo | Recruiting |
| Novartis Investigative Site | São Paulo | São Paulo | Active Not Recruiting |
+ 124 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in Japan
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 NCT06133972 on ClinicalTrials.gov ↗ ← All trials in Japan