Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Systemic Lupus Erythematosus
In brief
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).
Key facts
- Study ID
- NCT06133972
- Run by
- Novartis Pharmaceuticals
- People needed
- 550
- Starts
- 2024-05-21
- Expected to finish
- 2032-04-05
- Last updated by the study team
- 2026-07-08
Who can join
Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Caba, Argentina (enrolling)
- Novartis Investigative Site — Salvador, Estado de Bahia, Brazil (enrolling)
- Providence Medical Center — Burbank, California, United States (enrolling)
- Pinnacle Research Group Llc — Anniston, Alabama, United States (enrolling)
- Novartis Investigative Site — Maroochydore, Queensland, Australia (enrolling)
- Advanced Medical Research — La Palma, California, United States (enrolling)
- IRIS Research and Development — Plantation, Florida, United States (enrolling)
- Clinical Research of West Florida Inc — Tampa, Florida, United States (enrolling)
- University of Colorado Denver — Aurora, Colorado, United States (enrolling)
- Robert A Hozman MD SC — Skokie, Illinois, United States (enrolling)
- Clinical Res Of W Florida — Clearwater, Florida, United States (enrolling)
- Accurate Clinical Research — Lake Charles, Louisiana, United States (enrolling)
- GNP Research — Cooper City, Florida, United States (enrolling)
- Henry Ford Health — Detroit, Michigan, United States (enrolling)
- Ahmed Arif Medical Research Center — Grand Blanc, Michigan, United States (enrolling)
- Paramount Med Rsrch and Consult LLC — Middleburg Heights, Ohio, United States (enrolling)
- West Tennessee Research Institute — Jackson, Tennessee, United States (enrolling)
- Shelby Research LLC — Memphis, Tennessee, United States (enrolling)
- Parris and Associates Rheumatology — Lawrenceville, Georgia, United States (enrolling)
- Accurate Clinical Research — League City, Texas, United States (enrolling)
- Epic Medical Research — Red Oak, Texas, United States (enrolling)
- Novartis Investigative Site — La Plata, Buenos Aires, Argentina (enrolling)
- Novartis Investigative Site — Quilmes, Buenos Aires, Argentina (enrolling)
- Willow Rheumatology Wellness — Willowbrook, Illinois, United States (enrolling)
- Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)
Full record on ClinicalTrials.gov
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