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Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

NCT06711887

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Lupus Nephritis

Interventions: Ianalumab

Countries: United States, Brazil, China, Colombia, Czechia, Guatemala, Hong Kong, Hungary

The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and 2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Signed informed consent prior to participation in the extension study.
2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.

Exclusion Criteria:

1. Use of prohibited therapies
2. Pregnant or nursing (lactating) women.
Locations (41)
  • Orchard Park, New York, United States
  • Vitória, Espírito Santo, Brazil
  • Salvador, Estado de Bahia, Brazil
  • Belo Horizonte, Minas Gerais, Brazil
  • Santo André, São Paulo, Brazil
  • Guangzhou, Guangdong, China
  • Shantou, Guangdong, China
  • Shenzhen, Guangdong, China
  • Liuzhou, Guangxi, China
  • Wuhan, Hubei, China
  • Changchun, Jilin, China
  • Binzhou, Shandong, China
  • Beijing, China
  • Chongqing, China
  • Guangzhou, China
  • Guangzhou, China
  • Shanghai, China
  • Barranquilla, Atlántico, Colombia
  • Olomouc, Czechia
  • Prague, Czechia
  • Guatemala City, Guatemala
  • Guatemala City, Guatemala
  • Tuenmen, Hong Kong
  • Budapest, Hungary
  • Kuala Lumpur, Kuala Lumpur, Malaysia
  • Sibu, Sarawak, Malaysia
  • León, Guanajuato, Mexico
  • Oaxaca City, Mexico
  • Querétaro, Mexico
  • Bucharest, Romania
  • + 11 more on CT.gov