Projekt
CAIN457Q12301
Automatisch geschlossen · 2020 bis 2023
Bartz-Batliner Mira, Hutz Carina Liane, Peischl Riana, Rubbert-Roth Andrea, Sasselli Clelia
Art
Klinische Forschung
Reichweite
Multizentrisch, KSSG als teilnehmendes Zentrum
Bereiche
Status
Automatisch geschlossen
Start
2020
Ende
2023
Finanzierungsart
Industrie
Studiendesign
A pivotal, randomized, double- blind, placebo controlled trial evaluating at week 52 the efficacy and safety of secukinumbab versus placebo in subjects with active LN also receiving background SoC regimen. Long- term efficacy, saftey and tolerability will be collected up to 2 years.
Kurzbeschreibung/Zielsetzung
A two-year, phase III randomized, double-blind, parallel- group, placebo- controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. secukinumab versus placebo in combination with SoC therapy in patients with active lupus nephritis