Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Lupus Nephritis
In brief
This was a pivotal, randomized, double-blind, placebo-controlled trial evaluating at Week 52 the efficacy and safety of secukinumab versus placebo in patients with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features) also receiving background standard of care therapy (SoC).
Key facts
- Study ID
- NCT04181762
- Run by
- Novartis Pharmaceuticals
- People needed
- 275
- Starts
- 2020-07-07
- Expected to finish
- 2023-09-13
- Last updated by the study team
- 2025-05-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Kaiser Permanente Fontana — Fontana, California, United States
- University of California LA — Los Angeles, California, United States
- Arthritis and Rheum Dise Spec — Aventura, Florida, United States
- Integral Rheumatology and Immunology Specialists IRIS — Plantation, Florida, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- Beth Israel Deaconess Hospital — Boston, Massachusetts, United States
- Ahmed Arif Medical Research Center — Grand Blanc, Michigan, United States
- Novartis Investigative Site — Caba, Buenos Aires, Argentina
- Novartis Investigative Site — Ciudad Autonoma de Bs As, Buenos Aires, Argentina
- Novartis Investigative Site — Córdoba, Argentina
- Novartis Investigative Site — Westmead, New South Wales, Australia
- Novartis Investigative Site — Fortaleza, Ceará, Brazil
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
- Novartis Investigative Site — Joinville, Santa Catarina, Brazil
- Novartis Investigative Site — Santo André, São Paulo, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — São José do Rio Preto, Brazil
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Valdivia, Los Ríos Region, Chile
- Novartis Investigative Site — Santiago, RM, Chile
- Novartis Investigative Site — Concepción, Chile
- Novartis Investigative Site — Santiago, Chile
- Novartis Investigative Site — Nanning, Guangxi, China
- University Of Alabama — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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